MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problems Cut In Material (2454); Device Damaged by Another Device (2915)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device: 1 year, 4 months.The replaced portion of the driveline was received for evaluation.Approximately 27 inches of the distal end of the driveline was returned.The outer silicone sleeve, clear bionate, and metal braided shield layers had been cut approximately 25 inches from the distal metal connector.Approximately 2 inches of five of the six driveline wires were exposed; the proximal end of the red wire was not exposed.The five exposed wires at the proximal end of the driveline were tested for electrical continuity and did not reveal any discontinuities.When the outer silicone sleeve was slightly pulled back, a slice in the clear bionate and damage to the underlying braided shield and wires was observed at approximately 24 inches from the metal connector.Visual inspection of the underlying wires revealed a fractured end of the red wire and a partially fractured orange wire in the area of the damaged outer layers of the driveline.The evaluation findings are consistent with the report by the technical services representative that a broken red wire was detected during the evaluation of the driveline prior to the replacement procedure.The observed wire damage appeared to be the result of mechanical trauma to the driveline and is consistent with the report that the driveline was accidentally damaged with a chainsaw.The fractured wire conductors would have caused the reported driveline fault alarms.No other areas of compromised wire insulation or conductor damage were identified along the remainder of the returned driveline segment.A review of the device history records revealed the device met applicable specifications.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 the patient had an accident with a chainsaw and part of the driveline was cut.Driveline fault alarms sounded and the patient presented to the hospital for evaluation.Upon arrival, lacerations were observed on the abdomen, arms and at the exit site of the driveline.There were no reports of any interruption in lvad support.Upon evaluation of the driveline, it appeared that a wire was severed but they were not able to tell the exact wire.The patient's medical and surgical teams determined that the best approach was to perform a surgical revision in order to expose enough of the driveline to allow a distal driveline replacement procedure.The driveline repair was performed by the manufacturer's technical services representatives in the operating room after verifying with the surgeon that enough of the driveline was available.Continuity testing confirmed a broken red wire.The driveline repair was performed with no issues.No further driveline fault alarms occurred after the external portion of the driveline was replaced.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5658984
• MDR Text Key: 45302348
• Report Number: 2916596-2016-00923
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 109