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

Model Number 106015

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

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

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 presented with driveline silastic tears.The driveline was repaired with rescue tape.Patient support was ongoing.

Manufacturer Narrative

Manufacturer's investigation conclusion: damage to the silicone jacket of the patient¿s driveline was confirmed through the evaluation of the submitted photographs.A specific cause for the observed damage could not be conclusively determined.Review of the account¿s submitted images revealed damage to the silicone jacket of the external portion of the driveline, and an area of rescue tape partially covering the jacket as well as the controller connector bend relief.No wires were visible, and the damage appeared to be cosmetic only.Additionally, the submitted x-rays revealed no areas of concern in the metal braided shield.Review of the account¿s submitted log file revealed no atypical events or alarms indicating an issue with the patient¿s driveline.The pump appeared to function as intended and operated above the low-speed limit for the duration of the file.The account reported that the driveline was repaired with rescue tape.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The hmii lvas instructions for use (ifu), rev.H, is currently available.Section 6 ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) 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 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The hmii lvas patient handbook, rev.G, is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline and instructs to not twist, kink, or sharply bend the driveline.Section 6 "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.No further information was provided.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
• 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: 13026573
• MDR Text Key: 284144217
• Report Number: 2916596-2021-07067
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2016
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 109 KG