MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE INFLOW CANULA; VENTRICULAR (ASSISST) BYPASS

Model Number 106523US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  Injury  

Event Description

Abbott heartmate 3 left ventricular assist device (lavd) was implanted in 2018.The inflow canula associated with lvad pump formed a shallow fibrous growth on the inflow canula.Patient was transplanted on 2020.Surgical pathology note below confirmed the finding.Heartmate 3 lvad in place with shallow fibrous pannus-like growth on the inflow cannula (outside and focally inside).

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE INFLOW CANULA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12467025
• MDR Text Key: 271251605
• Report Number: 12467025
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 106523US
• Device Catalogue Number: 106523US
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21900 DA