MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAS, EUROPE; DSQ: LEFT VENTRICULAR ASSIST DEVICE

Model Number 104912

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/30/2014

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad).Approximately 22 months post-implant, it was reported that the patient was returned to the operating room to reconnect the outflow graft bend relief that had become disconnected (mfr report number 0002916596-2013-00558).During the procedure, the surgeon noticed that the graft was eroded at the point where the metal part of the bend relief was in contact with the graft and therefore, the outflow graft and bend relief were replaced and a sealed outflow graft bend relief collar was applied.

Manufacturer Narrative

The pump remains implanted and in use by the patient and the suspect outflow graft and bend relief were disposed of by the hospital.No photos were taken by the hospital prior to disposal.No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: HEARTMATE II LVAS, EUROPE
• Type of Device: DSQ: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORP.; 6035 stoneridge dr.; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth ave.; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3662392
• MDR Text Key: 4355836
• Report Number: 2916596-2014-00172
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 104912
• Device Catalogue Number: 104912
• Device Lot Number: 111619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2014
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2014
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention