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

Catalog Number 104911

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

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

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Age of device: 5 years, 22 days.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 left ventricular assist device (lvad) on (b)(6) 2013.It was reported that pump stoppages occurred while the device as on batteries.An ungrounded power module patient cable was in use at the time of the event.The manufacturer's technical services performed a percutaneous lead (driveline) replacement on (b)(6) 2018.At midnight on (b)(6) 2018, pump stoppages occurred again.The patient was asymptomatic during the pump stoppages.On (b)(6) 2018, the patient underwent a pump exchange.It was reported that patient was discharged home and was doing well.No further information was provided.

Manufacturer Narrative

Evaluation of heartmate ii lvas, serial number (b)(4), confirmed internal driveline wire damage that would have contributed to the reported event.The pump was returned with the driveline cut approximately 2.5¿ from the pump housing with an additional 14.5¿ segment was returned, as well as a 26¿ distal portion of the driveline also returned.A driveline repair was previously performed and 19¿ of the replaced portion of the dl was also returned.The inflow conduit (inlet tube, flex section, and inlet elbow), sealed outflow graft, and sealed outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Evaluation of the outflow elbow revealed no evidence of depositions or thrombus formations.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(4) also revealed no evidence of depositions or thrombus formations.The replaced segment of the driveline (from (b)(4) was visually inspected and underwent continuity and hipot testing.These tests did not identify any breaches to the wires that would have resulted in the reported event.Both the pump-end segment and the distal segment of the driveline were tested for electrical continuity in the condition that they were received and did not reveal any discontinuities or shorts.The outer silicone jacket, clear bionate cover, and the metal braided shield were carefully removed in order to evaluate the underlying wires.Visual examination of the distal segment of the dl revealed breaches to the insulation of the black and yellow wires, approximately 1 inch away from the pump housing.The observed wire damage appeared to be the result of abrasion from the metal shield as a result of repetitive flexing of the driveline in this location.Both the pump-end segment and the distal segment of the driveline were then submerged in a saline solution for hi-pot testing to further verify the integrity of each wire's insulation.This test did not reveal any additional areas of current leakage.If the exposed conductors of black and yellow wires made contact with each other, or simultaneous contact with the braided shield while the patient was operating on batteries, the resulting phase-to-phase short could have resulted.This could cause the hazard alarms and pump stops that were confirmed through the evaluation of the submitted log file.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7640303
• MDR Text Key: 112442723
• Report Number: 2916596-2018-02615
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• 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: 12/14/2018

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: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88