MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524US

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that during implantation, specifically during tunneling of the lance through to the exit site, a tunneling adapter leaflet broke off.The surgeon could not find the broken flange near the exit site or inside the chest cavity and the chest was closed.No adverse events were reported.No further information was provided.

Manufacturer Narrative

Section b5: additional information.Section e4: corrected information.Section e4: initial reporter reported the event to fda under medwatch report mw5085116 manufacturer's investigation conclusion: the report of damage to the tunneling adapter was confirmed through the submitted photographs.Multiple requests for additional information regarding whether the tunneling adapter would be returned were sent to the customer; however, no additional information was received.The patient remains ongoing on vad support.The tunneling adapter was not returned to abbott for analysis.The surgical procedures section of the hm3 ifu describes how to attach the tunneling adapter and how to create the driveline exit site.This document also instructs the user to confirm that the yellow line on the tunneling adapter is fully covered for a secure connection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the piece of plastic that is missing is 8.5 millimeters by 5 millimeters by 2 millimeters.It is thought that the piece become embedded in the driveline tract.No further information was reported.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8477961
• MDR Text Key: 140753348
• Report Number: 2916596-2019-01454
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6824253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 108