MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Mechanical Problem (1384); Pumping Stopped (1503)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient has damage to the percutaneous portion of the driveline 4.25¿ from the exit site above the connector causing short to power lines.The pump was off.The site planned to go on site to re-insulate the exposed wires and secure the damaged area.Log file review was requested, and the log files captured pump stops on (b)(6) 2024 due to fuse a & b being open in the system controller.Technical services noted that a short in the driveline was a possible cause of the fuses opening.Technical services originally stated that if a controller swap did not resolve the issue, this would indicate the driveline short was active.The customer additionally stated that at the time of the log file review, no controller exchange had been attempted despite statements to the contrary.The customer then reported that the controller was exchanged, and the pump restarted.An insulation repair was scheduled the for patient with the cut driveline above the modular connector.Visual inspection showed the cut to driveline with damaged kevlar and exposed wires.The site pulled back the silastic layer, kevlar, and bionate on either side of the cut.They noted slices through yellow, green, and blue wires that could have caused a short if touching (or touching through conductive intermediary such as knife).The damaged wires were wrapped in kapton tape, and then all wires were wrapped in additional kapton tape to add further protection and rigidity.The open area was wrapped with rescue tape.Related manufacturer reference number: 2916596-2024-01521 (controller).

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18982148
• MDR Text Key: 339551241
• Report Number: 2916596-2024-01520
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2024
• Device Model Number: 106524US
• Device Lot Number: 8383305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American