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

Catalog Number 104911

Device Problems Device Stops Intermittently (1599); Incorrect Device Or Component Shipped (2962)

Patient Problem Low Cardiac Output (2501)

Event Date 02/13/2016

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 2 years and 3 months.The device was returned for investigation.The evaluation is not yet complete.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).It was reported that on (b)(6) 2016, while prepping and draping the patient for a heart transplant, a sudden pump stoppage occurred and the system controller alarmed ''connect driveline.'' at the time of the pump stoppage, no one was touching the patient, system controller, percutaneous lead, patient cable or the power module.It was reported that the percutaneous lead was fully engaged.The hospital staff disconnected the percutaneous lead and reinserted it, without resolution to the alarm.The patient was placed on battery power in case of a short to shield condition but the alarm did not resolve.It was reported that patient became hemodynamically unstable and the hospital staff exchanged the system controller with the patient's backup system controller and the pump started.The patient was prepped and draped, and right after the surgical incision was made pump stoppages re-occurred.The percutaneous lead was jiggled, and the pump started and stopped.The hospital staff was able to maintain pump function by holding the percutaneous lead in just the right position for 1.5 hours, until the patient safely went on bypass.The event could not be reproduced again.The patient was transplanted and no further issues were reported.

Manufacturer Narrative

The evaluation of the returned pump confirmed internal driveline wire damage that could have contributed to the reported event.The pump was returned assembled with the driveline cut approximately 2.5 inches from the pump housing and the remainder of the driveline was returned in two segments measuring approximately 6 inches and 30.5 inches long, respectively.Visual examination the driveline segments revealed a breach in the insulation of the brown wire, approximately 2 inches from one of the cut ends of the 6 inches long segment.High potential testing revealed no additional areas of current leakage.If the exposed conductors of the brown wire contacted with the braided shield while the system was operating on the power module, the resulting short to ground would have interrupted pump function and resulted in the reported red heart alarms and pump stoppages.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5499553
• MDR Text Key: 40299092
• Report Number: 2916596-2016-00455
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 66