MAUDE Adverse Event Report: ABBOTT ABBOTT; HEARTMATE 3

Model Number 106524US

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problem Heart Failure (2206)

Event Date 10/03/2019

Event Type  Injury  

Event Description

Over the past few months patient reports worsening nyha class 2-3 symptoms that have not improved despite escalation of outpatient diuretics.Recent ttes have shown ongoing rv dysfunction.Pump speed increase resulted in brief symptomatic improvement, but patient continued to have worsening heart failure symptoms.Labs remained relatively stable with slightly up-trending creatinine.Patient was admitted (b)(6) for further workup.Cta on (b)(6) 2019 showed an outflow cannula with 50% occlusion.Occlusion was felt to be caused by a twist in the graft resulting in kinking.Patient was taken to the operating room on (b)(6) for revision of the outflow graft.Graft was found to be 75-90 degrees rotated from original position.After adjustment of the outflow graft the locking clip was applied.Patient's speed was able to be reduced 600rpms with adequate support.

• Brand Name: ABBOTT
• Type of Device: HEARTMATE 3
• Manufacturer (Section D): ABBOTT; abbott park IL
• MDR Report Key: 9219237
• MDR Text Key: 163977098
• Report Number: 9219237
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 10/08/2019
• 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: 32 YR
• Patient Weight: 87