MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP; VENTRICULAR (ASSIST) BYPASS

Model Number	103695
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that log files were submitted for a patient with extensive damage and wear on their driveline, which had occurred over many years.The patient denied any alarms.Despite the damage observed to the driveline, the log file data indicated that the internal conductors were still intact.An external driveline revision was not required at this time.There were (2) no external power events recorded while connected to mobile power unit (mpu).This was likely caused by power to the mpu being briefly interrupted.The emergency backup battery was used to support the system during these events.Motor function was not affected by this event.Regarding the mpu, the power cord was of the locking type.The patient stated they did not recall these specific power events, but they lived in a semi-rural area and had frequent power outages from clay electric.The system controller had never had an alarm that they could recall without there being an explainable power outage.Layers of rescue tape was applied just behind the clam shell repair and to gradually reduce the layers as the wrapping continued toward the exit site to reproduce a bend relief.
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
The onset of the patient's driveline damage is reported under mfr #: 2916596-2019-00579.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported driveline damage was confirmed through the submitted images.A specific cause for the damage could not be conclusively determined through this evaluation.Evaluation of the submitted images showed the outer jacket had multiple areas of tears and damage of the outer jacket with portions of the outer jacket missing.The bionate layer was visible in the areas of damage and appeared discolored, but intact.Multiple attempts were made to obtain additional information regarding the reported event; however, no further information was provided by the account.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number vad-7157.No further related events have been reported at this time.The heartmate ii lvas instructions for use (ifu) and patient handbook discuss wear and tear to the driveline, contain information on caring for the driveline, and provide possible indications of driveline damage as well as how to respond to such events.The heartmate (hm) ii left ventricular assist system (lvas) instructions for use (ifu) rev.C and the heartmate ii patient handbook rev.C are currently available.Section 6 of the ifu, ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ and provides possible indications of driveline damage as well as how to respond to such events.This section also instructs to check the driveline daily for signs of damage, such as cuts, holes, or tears.Section 8 of the ifu, ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.Section 4 of the patient handbook, ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 6 of the patient handbook, "caring for the equipment" discusses damage due to wear and fatigue of the driveline and outlines indications of driveline damage, as well as how to respond to such events.The relevant sections of the device history records for vad-7157 were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20251478
• Report Number: 2916596-2024-06038
• Device Sequence Number: 12802713
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)121231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2012
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/22/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 122 KG