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

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

Heartmate left ventricular assist device (lvad) presents with acute symptomatic low flow alarms 9 months into lvad therapy.Etiology initially thought to be thrombus; later confirmed to be malposition of inflow cannula per computerized tomography angiogram.Patient underwent reposition of the inflow cannula via left thoracotomy pericardial window with subsequent resolution of low flow alarms.

• Brand Name: HEARTMATE 3¿
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 4550 norris canyon rd; san ramon CA 94583
• MDR Report Key: 9952873
• MDR Text Key: 187392516
• Report Number: 9952873
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2020
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Weight: 61