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

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

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

Event Date 11/16/2016

Event Type  malfunction  

Event Description

Heartmate 2 lvad presents with pump stops suggestive of driveline fracture on (b)(6) 2016.Underwent failed attempt at splice repair of the external driveline by abbott technicians on (b)(6) 2016, requiring urgent heartmate 2 to heartmate 2 exchange via thoracotomy approach on (b)(6) 2016.

• Brand Name: HEARTMATE II
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10004845
• MDR Text Key: 189185258
• Report Number: 10004845
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 04/17/2020
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 96