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

Model Number 106015

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

This information was previously reported under mfr: 2916596-2020-05038, these were deemed separate events and will be reported separately.

Event Description

It was reported the patient contacted the heartline and communicated that the white silicon layer has been taped up.He indicted that the wires may be showing, but does not have any alarms.

Manufacturer Narrative

Manufacturer's investigation conclusion: damage to the outer jacket of the patient¿s driveline could not be confirmed as no product was returned for evaluation and no images were provided by the account for review.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and no further events have been reported at this time.The heartmate ii lvas ifu, rev.H and the heartmate ii patient handbook, rev.G are currently available.Sections 6 and 8 of the hmii ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2016.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
• MDR Report Key: 11296452
• MDR Text Key: 241053672
• Report Number: 2916596-2021-00627
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5677181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 99