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

Catalog Number 107801

Device Problems Device Stops Intermittently (1599); Cut In Material (2454)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4): the replaced portion of the driveline was received for investigation.The evaluation is not yet complete.The patient remains ongoing on lvad support.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.During a clinic visit, a cut in the outer coating of the driveline was observed that the patient reported had occurred the week prior.Upon manipulation of the area, the system controller sounded low speed advisories and a pump stoppage occurred.The patient was asymptomatic.On (b)(6) 2016, the patient's driveline was repaired by the manufacturer's technical services representatives.It was reported that the repair appeared to be successful.No subsequent events have been reported.

Manufacturer Narrative

Device evaluation: the evaluation of the returned portion of the driveline confirmed an issue that would have contributed to the reported low speed events and pump stoppage.A distal end driveline replacement was performed and approximately 15 inches of the external portion/distal end of the driveline was returned for evaluation.Electrical continuity testing of the driveline segment revealed that all wires were electrically intact.The tongue depressors, cotton, and tape which were previously used to stabilize the driveline were removed, and the reported area of superficial damage to the outer silicone sleeve was noted at approximately 4.75 inches from the metal connector.Upon removal of the outer silicone sleeve, the clear bionate layer appeared unremarkable.Breakdown of the metal braided shield was observed near the terminus of the distal end bend relief at approximately 2.5-3.5 inches from the metal connector.Visual inspection of the underlying wires in the location of shield breakdown found that the orange wire was partially fractured at approximately 2.75 inches from the metal connector.The observed wire damage appeared to be the result of fatigue failure due to repetitive flexing of the driveline in this area.If the exposed conductors of the orange wire made contact with the braided shield while the patient was operating on a tethered power source such as the power module, the resulting electrical short to ground would have caused the reported low speed events and pump stoppage that were confirmed via the submitted system controller log file.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 DEVICE
• 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: 5485259
• MDR Text Key: 39843274
• Report Number: 2916596-2016-00409
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 107801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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: 44 YR
• Patient Weight: 88