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

Catalog Number 29257

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 11/16/2016

Event Type  malfunction  

Event Description

Patient with heartmate ii left ventricular assist device (lvad) for 60 months presents with recurrence of vad alarms, vad stops requiring 2nd attempt at splice repair of the external driveline the day after he presented.Unfortunately, the splice repair was unsuccessful requiring urgent heartmate ii lvad exchange.

• Brand Name: HEARTMATE II LVAS
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 23 4th ave.; burlington MA 01803
• MDR Report Key: 6272514
• MDR Text Key: 65598730
• Report Number: 6272514
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 29257
• Device Lot Number: 97712
• 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: 01/12/2017
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 01/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 64 YR
• Patient Weight: 95