FRAMINGHAM, Mass., June 8, 2015 /PRNewswire/ -- HeartWare
International, Inc. (NASDAQ: HTWR) issued a voluntary Urgent
Medical Device Correction on May 11,
2015, describing five different types of complaints reviewed
as part of HeartWare's ongoing product performance monitoring. The
notice provides information to reinforce proper performance and
safe use of the HeartWare® Ventricular Assist System to
help reduce the potential occurrence of avoidable patient
injury. In letters to clinicians and patients, the company
reminds patients with HeartWare System product codes 1101 and 1103
to follow directions in the Patient Manual and to be aware of
certain signs of wear. Specifically, the notice calls
attention to the following points:
- Maintaining Continuous Power Supply – The notice reminds
patients never to disconnect the HVAD® Pump from both
power sources at the same time. The HVAD®
controller has an internal battery with the sole purpose of
powering a "double disconnect alarm" in the unlikely event that
both power sources are simultaneously disconnected. Like all
batteries, this battery may degrade with age. If there is a
complete interruption of power (i.e., a "double disconnect") and
the internal battery is discharged or underpowered, there may not
be an audible alarm. The internal battery is the final
mitigation in a cascade of power management risk controls, which
include labeling, patient training and alarms related to external
battery charge. A failure of the internal controller battery
has no impact on normal functionality of the controller and is
unlikely to have a clinical impact, provided patients follow the
Patient Manual and never disconnect from both power sources at the
same time.
- Worn Alignment Guides – The alignment guides in the
controller's power supply connector ports may wear down over
time. The notice instructs patients to inspect their
controller's power supply ports for potential wear or damage to the
alignment guides or connection pins. If damage is found,
patients should use care when connecting power sources to avoid
twisting or bending the power connection pins, and should contact
their healthcare provider to schedule an appointment and possibly
arrange for a replacement controller. Over time, substantial
wear-and-tear to power supply connectors could result in the
inability to connect to a power source, potentially resulting in an
interruption in electrical connectivity, which could lead to a pump
stop. Pump stops could cause death or serious injury.
During the past 18 months, HeartWare has been made aware of worn
alignment guides in approximately 1% of distributed
controllers. HeartWare has initiated a program to improve the
strength of the alignment guides in the controller's power supply
connector ports to reduce possible damage to the connection
pins.
- Power Management Software Upgrades – In certain
situations, it is possible that a temporary loss of communication
between the controller and the batteries can result in premature
"battery switching" or false battery alarms. Unnecessary
battery switching and false battery alarms do not increase risk to
patients, but may result in an increase in alarms or the need for
more frequent battery changes. HeartWare is developing a
software upgrade to improve how the controller manages a transient
loss of communication between the controller and HVAD System
batteries. The software upgrade is expected to become
available later in 2015, at which time physicians will notify their
patients. In the meantime, the notice reminds patients to
always treat battery alarms in accordance with the instructions in
the Patient Manual.
- Driveline Outer Sheath Discoloration and Cracking –
Patients should be aware that the driveline outer sheath may become
discolored or display small cracks over time. This outer,
protective covering contains a plastic material that may degrade if
exposed to excessive ultraviolet (UV) light, such as from direct
sunlight or tanning beds, while the internal driveline conductors
remain protected and intact. Discolored or cracked outer
sheaths have not demonstrated an elevated safety risk, but could
contribute to the risk of infection at the exit site. The
notice reminds patients to keep their driveline protected under
their clothing as described in the Patient Manual. HeartWare
introduced a thicker sheath in 2013 internationally and
2014 in the U.S. that has generated fewer complaints
related to discoloration and cracking than the thinner
sheath.
- Driveline Pulling and Snagging – Patients should take
care when managing their drivelines to avoid accidental snagging or
pulling, which could cause damage to the driveline or a
disconnection. If a driveline is severely damaged or
disconnected from the controller, electrical issues or pump stops
are possible, which could lead to serious injury or death.
Patients are reminded to follow the instructions in the Patient
Manual and not to pull, kink or twist their drivelines. For
example, the notice reminds patients to avoid catching their
driveline on hazards such as door knobs, seat belts or vehicle
brake handles.
Patients who experience these issues should contact their
physician or VAD Coordinator at their hospital center. Clinicians
with questions should contact their HeartWare representative, call
HeartWare's 24-hour Clinical Support line at (888) 494-6365 or
email FSCA@heartware.com.
HeartWare has advised the U.S. Food and Drug Administration
(FDA) of this action. Adverse reactions or quality problems
experienced with the use of this product may be reported to FDA's
MedWatch Adverse Event Reporting program either online, by regular
mail or by fax:
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form. Then, complete and return the form to the
address on the pre-addressed form, or submit by fax to
1-800-FDA-0178.
About HeartWare International
HeartWare International
develops and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat patients suffering from
advanced heart failure. For additional information, visit the
company's website at www.heartware.com.
Investor and media contact:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.