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

Model Number 103695

Device Problems Mechanical Problem (1384); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Driveline repair in july of 2019 captured in mfr#: 2916596-2019-03471.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient experienced driveline faults that resurfaced from a past problem from on (b)(6) 2019 and patient was trailed on ungrounded cables.The problem stemmed from a tear in the silicone jacket.The driveline repair was completed at the time but did not resolve the alarm.Log file review confirmed multiple strings of yellow wrench alarms that were associated with driveline faults noted in this event.Phase a continued to show further degradation while the other two phases appeared normal.There were no other unusual events recorded in the log file event history.It was noted that the tear in the silicone jacket appeared to be cosmetic only and it was recommended that the affected area be wrapped with rescue tape.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: review of the submitted photograph confirmed damage to the driveline's outer jacket; however, the reported event of exposed driveline wiring could not be confirmed.The submitted photograph captured a portion of the patient¿s external driveline.Damage to the outer jacket was observed adjacent to the proximal end of the existing driveline repair.It should be noted that no exposed wires were observed.The submitted log file contained events from 24sep2022 through 29sep2022, per the timestamps.Silenced driveline fault alarms were captured throughout the majority of the file.Based on previous complaint experience, the alarms appeared consistent with a potential driveline issue.No other notable events or alarms were captured.The pump operated at or above the low speed limit for the duration of the file.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6), with no further reported issues 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 ifu also outlines all system controller alarms, including the driveline fault, and how to respond to each alarm condition.The relevant sections of the device history records for (b)(6), original driveline, serial number (b)(6), and replacement driveline, serial number (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specification.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15545269
• MDR Text Key: 306521998
• Report Number: 2916596-2022-14255
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: 00813024010616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• 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
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 86 KG