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

Model Number 105306

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  malfunction  

Manufacturer Narrative

Approximate age of device - 4 years, 1 months.The patient remains ongoing with the device.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 (lvad) on (b)(6) 2014.On (b)(6) 2018, it was reported that the patient's pump was stopping as soon as being connected to the power module.On 06jun "201", the manufacturer¿s technical service representative reviewed supplied x-ray and system log files which confirmed a pump stop while connected to the power module.The x-ray revealed the percutaneous lead to be wrapped around the outflow and it appeared to be pulled tightly.The external view of the percutaneous lead showed wear and tear.A no ground patient cable was provided.On (b)(6) 2018, the manufacturer¿s technical service representative successfully performed a percutaneous lead repair.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned portion of the driveline confirmed wire damage that could have contributed to the low speed and pump stop events that were captured in the submitted log file.A distal end driveline replacement was performed by a technical services representative.Approximately 20¿ of the external portion/distal end of the driveline was returned.A rescue tape repair was present, approximately 1.5-17.5¿ from the metal connector.Electrical continuity testing of the returned driveline was conducted and all wires were found to be electrically intact.No wire-to-wire or wire-to-shield shorts were induced during this testing, even with manipulation of the driveline.The pins of the metal connector appeared free from deformation.Upon removal of the rescue tape, multiple tears to the silicone sleeve were observed.The clear bionate was twisted in multiple locations, 0.25-1.5¿, 3.25-4.5¿, and 7-9¿ from the metal connector.Shield breakdown was also observed in these locations.Visual inspection of the wires found that the orange wire had been punctured by a piece of the metal braided shield in one of the twisted areas, approximately 3.5" from the metal connector.The orange wire redundantly supports motor phase 3.The remainder of the driveline was 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.The pump stops and hazard alarms that were confirmed through the analysis of the patient's log file could have resulted from a short to ground if the exposed conductors of the orange wire contacted the braided shield while the patient was supported by the power module.The patient remains ongoing on heartmate ii lvas.The hmii lvas ifu and patient handbook explain that all hm ii lvas drivelines have the potential for wire/shield breakdown to occur dependent on length of use and movement/flexing over time.Information regarding driveline care can also be found in both of these documents.Additionally, the hmii lvas ifu contains detailed information regarding pump speed, power, flow, and pi.This ifu also outlines all system controller alarms (including low flow hazard and pump off alarms), as well as how to respond to such events.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 95488
• MDR Report Key: 7658475
• MDR Text Key: 113054735
• Report Number: 2916596-2018-02702
• 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: 08/31/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2017
• Device Model Number: 105306
• Device Catalogue Number: 105306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 83