MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Infarction, Cerebral (1771)

Event Date 02/08/2020

Event Type  Injury  

Event Description

Patient with heparin allergy (+ heparin-induced thrombocytopenia) and critical illness (failed coronary artery bypass graft (cabg) surgery; failing clinical status on impella 5.5 support) prior to heartmate 3 implant, presents with acute right posterior cerebral artery (pca) infarct 5 days after lvad implant despite use of bivalrudin.

• Brand Name: HEARTMATE 3¿
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 9947885
• MDR Text Key: 187204650
• Report Number: 9947885
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 23360 DA
• Patient Weight: 78