MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problems Break (1069); Pumping Stopped (1503)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of damage to the pump cable was confirmed during the evaluation of the device.The center reported that the patient intentionally severed the pump cable to end support on (b)(6) 2018.A physician at the emergency department spliced the wires together and support was resumed.The patient subsequently received a pump exchange on (b)(6) 2018.The device was returned assembled with the pump cable severed approximately 12¿ from the housing.The severed portion of the pump cable showed the reported wire repair, which was bundled under white fabric tape.Under the tape, the wires that had been severed by the patient were stripped, twisted, secured with connector crimps, and insulated with additional white fabric tape.Each wire from the pump was correctly spliced to corresponding colored wire to the inline connector.Examination of the pump blood-contacting surfaces found no adhered depositions or thrombus formations.The pump rotor and rotor well showed no evidence of dents or scratches.The log files retrieved from the pump appeared to show several days of normal pump operation.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the patient intentionally cut through the driveline during a suicide attempt.The patient underwent a pump exchange on (b)(6) 2018.No additional information was provided.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8473191
• MDR Text Key: 140613816
• Report Number: 2916596-2019-01467
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 106524
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Date Device Manufactured: 07/08/2016
• 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: 55 YR
• Patient Weight: 157