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

Catalog Number 106016

Device Problems Break (1069); Pumping Stopped (1503); Cut In Material (2454)

Patient Problems Death (1802); Weakness (2145)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

The patient weight was not provided.Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 3 years and 2 months.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.It was reported that the patient attempted suicide by severing the driveline.The driveline was severed completely.It was reported that the patient did not collapse, and was later admitted to the intensive care unit.No treatments were provided.Approximately two weeks after the incident, it was reported that the patient's condition was very weak, and that the pump would not be exchanged.No additional information was provided.

Event Description

Correction: it was initially reported that date of this report: was 05/04/2016.The correct date is 05/04/2017.

Manufacturer Narrative

A full evaluation of the device could not be conducted as the device was not returned.The report the pump driveline being severed was confirmed via photographs submitted for evaluation.Photographs provided for review confirmed the driveline had been completely severed.The connector portion of the driveline remained connected to the system controller.The patient expired on (b)(6) 2017 and outcome information indicated the the cause of death was suicide.An autopsy was not performed and the pump was not explanted.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient expired on (b)(6) 2017.

• 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: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6543814
• MDR Text Key: 74400196
• Report Number: 2916596-2017-00894
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 106016
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2013
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 46 YR