MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU

Model Number 106016

Device Problems Break (1069); Device Stops Intermittently (1599)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device ¿ 3 years and 7 months.A full evaluation of the device could not be conducted as the device remains in use.Damage to the driveline¿s silicone sleeve was confirmed via customer submitted photos.No alarms were noted in the system controller history and no driveline x-rays were ordered.The patient remains ongoing on vad support.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device.It was reported that during a routine visit on (b)(6) 2018, the cardiologist reported damage to the percutaneous lead (driveline) and a pump stoppage.The driveline was repaired with silicon tape.Damage to the driveline's braided shield was observed.The patient was asymptomatic.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7640377
• MDR Text Key: 112437266
• Report Number: 2916596-2018-02368
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 54 YR