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

Catalog Number 103695

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem Unspecified Infection (1930)

Event Date 06/06/2015

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device.It was reported that the patient had recently been discharged from the hospital for a (b)(6) infection related to the percutaneous lead.The patient called the vad coordinator to report that she had removed some tape that had been placed over a tear in the percutaneous lead and noted some bloody/serous fluid leaking from the tear.It was reported that the patient has not had any alarms or any other complaints.On (b)(6) 2015, the patient was readmitted due to continued drainage from the percutaneous lead.X-rays appeared to show a separation of the silastic covering of the percutaneous lead from the pump housing.It was reported that the drainage was cultured with results of unspecified (b)(6), indicating infected internal bodily fluid.A pump exchange was completed on (b)(6) 2015 for an internally compromised percutaneous lead and a pump pocket infection.

Manufacturer Narrative

Approximate age of device ¿ 4 years and 11 months.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

A full evaluation of the device could not be conducted as the device was not returned.Although the change in orientation of the driveline between the time of implant and time of event was confirmed per x-ray evaluation, a separation of the silastic plastic from the pump housing could not be conclusively determined.A correlation between the device and the reported infection could not be conclusively determined.Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.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.

Manufacturer Narrative

The attached user facility medwatch report was received from the intermacs registry.The user facility number was not provided.(b)(4).

Event Description

Additional information was received from the intermacs registry stating: pt reported sero-sanguinous fluid leakage from nick of in external portion of driveline thought to be bodily fluid from a possible silastic disconnect from pump housing internally.Did patient experience a thrombus event (suspected or confirmed): no.Malfunction component: pump: yes.Malfunction component: pump: driveline: yes.Ae device malfunction: yes.Patient outcome: exchange: yes.Device malfunction causative factor: patient non-compliance.

• 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 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4889606
• MDR Text Key: 16310484
• Report Number: 2916596-2015-01219
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2012
• Device Catalogue Number: 103695
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 87