MAUDE Adverse Event Report: ABBOTT LABORATORIES / THORATEC CORP. HEARTMATE 3; VENTRICULAR (ASSIST) BYPASS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/13/2021

Event Type  Injury  

Event Description

Patient diagnosed with a driveline infection on (b)(6) 2020.Admitted for further evaluation.Taken to the operating room on (b)(6) 2020 for a debridement of the driveline exit site which showed infection tracking into the chest and possibly towards the lvad pump.Initial plans to perform a pump exchange were halted in light of the patients improved ef of 50-55% and the potential for pump explant.Vad speed decreased prior to discharge.Patient did not tolerate vad weaning as evidenced by a drop in ef to 15-20% on (b)(6) 2020.Decision was made to perform a pump exchange with an icd extraction prior to the exchange.Patient admitted (b)(6) 2020 for icd extraction however patient was discharged to home due to a positive covid-19 result.Patient admitted on (b)(6) 2021 for icd extraction which was successful.The patient was taken to the operating room on (b)(6) 2021 for a heartmate 3 pump exchange.During the surgery the surgeon noted there was no extension of the infection towards the lvad pump or outflow graft.Surgery went well.The patient is currently recovering on our telemetry unit.Fda safety report id# (b)(4).

• Brand Name: HEARTMATE 3
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES / THORATEC CORP. ; abbott park IL 60064
• MDR Report Key: 11222683
• MDR Text Key: 228680884
• Report Number: MW5098963
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 108