MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Material Separation (1562); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The patient remains ongoing with the lvad device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient has had continued connect to power alarms over the course of this year with a lot of intervention done by the hospital team.Log file was submitted.X-ray of the patient¿s abdominal area was taken to look for driveline fracture.The patient¿s log file history showed low voltage advisory and no external power alarms, however, the patient stated not having these alarms while on batteries but did report this back in (b)(6) 2020.The log file captured intermittent low voltage events (b)(6) 2020 and (b)(6) 2020 until (b)(6) 2020 while using battery power only.The images showed what looked like a clamshell repair and there is a little thinning of the shield at the distal end.In the absence of any low speed or pump stop events it looked to be a non-issue.The other image provided was unremarkable.It was observed that the patient's driveline had two small cosmetic tears in the outer silicone jacket wrapped with rescue/fusion tape.Driveline small tears were re-wrapped with new fusion tape.No further information was provided.

Manufacturer Narrative

Manufactures investigation conclusion: the reported tears in the outer jacket of the driveline were confirmed through review of the submitted images, as well as by an onsite evaluation performed by an abbott representative.A specific cause for the reported damage could not be conclusively determined through this evaluation.The submitted images of the patient¿s driveline confirmed two tears in the outer jacket that were covered by rescue tape.The damage was re-wrapped with rescue tape by an abbott representative.The submitted x-ray images were inconclusive for any areas of driveline wire compromise.The submitted log files showed the pump operating as intended above the low speed limit for the duration of the files.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) and patient handbook provide driveline care instructions.The patient handbook instructs the user to check the driveline daily for signs of damage (cuts, holes, tears).Call your hospital contact right away if the driveline is damaged (or might be damaged).No further information was provided.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11180023
• MDR Text Key: 244913430
• Report Number: 2916596-2020-06465
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6109654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 85