MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 2 LVAD; VENTRICULAR (ASSIST) BYPASS

Device Problems Fracture (1260); Pumping Stopped (1503)

Patient Problem No Code Available (3191)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Heartmate 2 left ventricular assist device (lvad) patient with ~ 1 year history of known driveline fracture (patient declined intervention at that time beyond use of ungrounded cable), now presents with pump stops on battery and wall power prompting hospitalization and surgical consult.Patient agreed to proceed with surgical exchange to heartmate 3.

• Brand Name: HEARTMATE 2 LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 4550 norris canyon rd; san ramon CA 94583
• MDR Report Key: 9952979
• MDR Text Key: 187397068
• Report Number: 9952979
• 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: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 04/03/2020
• Device Age: 3 YR
• 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: 28105 DA
• Patient Weight: 89