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

Model Number 103695

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

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

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

The referenced previous percutaneous lead (driveline) replacement was reported under medwatch mfr report# 2916596-2016-00859.Approximate age of device - 7 years, 10 months.The device was returned for analysis.Evaluation is not complete.No additional information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2010.It was reported that the patient presented to clinic today due to the lvad system producing low flow alarms with pump stoppages.The patient was asymptomatic.Log files were reviewed by the technical service representative and pump stoppage events were confirmed.X-rays provided to the technical service representative revealed areas that were of concern, however they were not able to confirm that the area was responsible for the pump stoppage events.It was previously reported that on (b)(6) 2016, the patient received a prior distal end percutaneous lead (driveline) replacement, and there was not enough length of the driveline remaining to perform a second replacement.On (b)(6) 2018, the vad coordinator confirmed that the patient was having a pump exchange due to suspect of internal percutaneous lead (driveline) damage.The pump will be returned for analysis.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of pump stoppages was confirmed based on the evaluation of the returned device.The pump was returned with the percutaneous lead (driveline) cut approximately 1.75¿ from the pump housing and the severed portion was returned.Examination of the pump portion of the driveline found it to be unremarkable.The brown wire on the severed portion of the driveline, approximately 2¿ from the pump housing, was damaged and broke off before continuity testing could be performed.Electrical continuity testing revealed discontinuities in the black, brown, red, yellow, and green wires.Visual inspection of the wires found insulation damage and wear in the yellow wire 2.5¿ from the pump housing and in the yellow, brown, and green wires 5.5¿ away from the pump housing.If the exposed conductors of the brown wire and either the yellow, or green wires made direct contact or simultaneous contact with the braided shield, the resulting phase-to-phase short could have caused the pump stop events captured on the submitted log files, while the system was operating on batteries.The pump stops that reportedly occurred while the system was operating on the power module could have occurred if any of the exposed conductors contacted the braided shield.The observed wire damage appeared to be the result of abrasion against the braided shield due to repetitive flexing.A review of the device history record revealed the device met applicable specifications.No further information was provided.The manufacturer is closing its 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: 7640365
• MDR Text Key: 112408877
• Report Number: 2916596-2018-02413
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 01/24/2019

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: 103695
• Device Catalogue Number: 103695
• 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: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 180