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 06/09/2018

Event Type  malfunction  

Manufacturer Narrative

Percutaneous lead replacement was reported under mfr# 2916596-2015-01984.Approximate age of device: 5 years, 4 months.The patient remains on lvad support with no issue reported.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2013.It was reported on (b)(6) 2018 that the patient was admitted to the emergency room with intermittent alarms on battery and ungrounded cable.The submitted log file was reviewed by the manufacturer¿s technical service representative and it was observed low speed and pump stoppages while the patient was on battery power and power module.On (b)(6) 2018 it was reported that the patient underwent lvad exchange on (b)(6) 2018 to another lvad.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the explanted pump was returned for evaluation.The evaluation of the pump confirmed an issue that could have contributed to the reported pump stoppages on both battery power and the ungrounded cable, which were observed in the submitted system controller log file.The pump was returned assembled with the percutaneous lead (lead) severed approximately 11 inches (") from the pump housing.The remainder of the lead was returned in a segment measuring approximately 29.5¿.The previous percutaneous lead repair was observed approximately 18¿ through 22¿ from the metal connector.Metal braided shield breakdown was observed along the length of the lead with severe breakdown observed adjacent to the nipple of the pump housing, adjacent to the metal connector, and approximately 2.5¿, 18¿, and 27.5¿ from the metal connector.Visual inspection of the underlying wires revealed that the yellow and orange wires were fractured adjacent to the metal connector, and a breach was observed in the insulation of the red wire adjacent to the metal connector, exposing the inner conductors.Hipot testing of the remainder of the percutaneous lead revealed additional breaches in the insulation of the black and green wires adjacent to the nipple of the pump housing, exposing the inner conductors.The observed wire damage appeared consistent with fatigue failure due to repetitive flexing and abrasion against the metal braided shield.If the exposed inner conductors of wires from two different motor phases made direct contact with each other or simultaneous contact with the metal braided shield, the resulting phase-to-phase short could have contributed to the pump stops and low speed hazard/advisory events observed in the submitted log file while connected to any power source.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
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488 3270
• MDR Report Key: 7661344
• MDR Text Key: 113173732
• Report Number: 2916596-2018-02693
• 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
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95