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

Model Number 106015

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

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - 1 year, 8 months.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that on (b)(6) 2018, a patient's system controller history interrogation was performed by the hospital clinician which revealed a pump stoppage.On (b)(6) 2018, an x-ray of the patient's percutaneous lead was found to be unremarkable by the manufacturer¿s technical service representative.On (b)(6) 2018, the manufacturer¿s technical service representative successfully performed a percutaneous lead (driveline) replacement.The patient was provided an ungrounded power module patient cable.Additional information has been requested but not provided.

Manufacturer Narrative

Patient weight not provided.Although the report of a pump stoppage event was confirmed based on review of the submitted system controller log file data, a cause for the recorded event could not be conclusively determined.An approximately 16 inch segment of driveline was returned for evaluation.Electrical continuity testing did not reveal any discontinuities or shorts.Breakdown of the braided shield was noted at the terminus of the connector bend relief.Visual inspection of the driveline revealed no evidence of mechanical damage or wear of the wire insulation.The driveline was submerged in a saline bath for hipot testing to check for current leakage through each wire's insulation.This test did not reveal any insulation breaches that would have contributed to an electrical short.The patient remains on vad support with the use of an ungrounded patient cable for power module support.No further related events have been reported.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7640426
• MDR Text Key: 112445592
• Report Number: 2916596-2018-02607
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR