MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; VENTRICULAR (ASSISST) BYPASS

Model Number 105581US

Device Problems Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

It was reported that the customer opened a kit for an implant and the outflow graft was defective so they had to use a standalone.A replacement was requested.It was reported that the outside lining looked slightly separated from the housing.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of the outermost layer of the outflow graft being slightly separated from the housing upon opening the heartmate 3 left ventricular assist system implant kit could not be conclusively determined through this investigation as no photos were submitted by the account and no product was returned for evaluation.The account opened a heartmate 3 left ventricular assist system implant kit and noticed that the outermost layer of the outflow graft was slightly separated from the housing.A standalone outflow graft was used, and there was no reported harm to the patient.The account communicated that they did not take any pictures of the defective outflow graft and that it would not be returned for evaluation as it was discarded.The surgical procedures section of heartmate 3 left ventricular assist system instructions for use (rev.C) contains information on "preparing the sealed outflow graft".The instructions for use also warns that, during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.There were no ncmrs related to the reported event.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11485898
• MDR Text Key: 239824034
• Report Number: 2916596-2021-01168
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 06/30/2021

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: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 7558253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1