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

Model Number 106015

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 initial submission of this event was reported by the manufacturer under mfr.Report #: 2916596-2018-01074.This report is being submitted as additional information.Reportable event type updated.The explanted pump is expected to be returned for evaluation.The replaced portion of the driveline was received; evaluation of both the driveline portion and the explanted pump will be completed together upon receipt of the pump.The patient remains ongoing on lvad support with the replacement device.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 a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the lvad system produced a pump stoppage event.The patient was asymptomatic.A log file was reviewed by the technical service representative and confirmed a pump stoppage.As of 05feb2018, the patient's lvad has been on battery power with no issues.A percutaneous lead (driveline) replacement was tentatively scheduled for (b)(6) 2018.A driveline replacement was performed on (b)(6) 2018.After the replacement, it was reported that pump stoppages occurred while the patient's lvad system was supported on a regular (grounded) patient cable.In addition, multiple pump speed decelerations were observed in the system controller history file on 01jun2018 which appeared consistent with continued short to shield.A pump exchange was subsequently performed on (b)(6) 2018.

Manufacturer Narrative

Device analysis: approximately 11 inches of the external portion/distal end of the driveline that was replaced on (b)(6) 2018 was returned for analysis.Rescue tape was observed 2 inches through 4 inches from the metal connector.Electrical continuity testing of the returned portion of the driveline revealed that all wires were electrically intact.No wire-to-wire or wire-to-shield shorts were induced during this testing, even with manipulation of the driveline.Upon removal of the rescue tape, damage to the silicone jacket was observed 2.5 inches from the metal connector.The clear bionate layer appeared unremarkable.Shield breakdown was observed adjacent to and 2.5 inches through 4 inches from the metal connector.The shielding was removed and examination of the underlying wires revealed no evidence of any breaches or damage to the wire insulation or underlying conductors.The driveline was submerged in a saline bath for high potential testing and the test did not reveal any current leakage in the insulation of any of the wires that would have resulted in an electrical short.The explanted device was retained by the hospital and was not available to be returned for analysis.Pump speed decelerations and pump stoppage events were confirmed based on the data contained in the submitted log file.These events occurred while the system was operating on the power module.Based on the manufacturer¿s previous complaint experience, the events recorded in the patient¿s system controller event history appear consistent with a potential driveline issue; however, driveline wire damage could not be confirmed.The submitted x-ray images did not show any areas of concern; however, an internal loop of the driveline was observed.The patient handbook contains a section on ¿caring for the percutaneous lead" and in addition, the instructions for use states all lvad percutaneous leads have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The heartmate ii lvas ifu provides also outlines indications of driveline wire damage as well as how to respond to such events.In addition, the ifu outlines all system controller alarms as well as how to respond.A review of the device history records revealed the device met applicable specifications.No further information is available.The manufacturer is closing the 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: 7645464
• MDR Text Key: 112581809
• Report Number: 2916596-2018-02464
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 118