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

Catalog Number 104911

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The referenced pump exchange was reported under medwatch mfr report #2916596-2016-02204.Approximate age of device  5 years and 2 months.The device is expected to be returned for evaluation.It has not yet been received.The reported outflow graft bend relief disconnection was incidentally noted during the pump exchange.No prior reports of the disconnect, or any events potentially related to the disconnect were received by the manufacturer.No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.This lvad was implanted prior to the following: historically, reports of disconnection of the bend relief from the sealed outflow graft were addressed through the manufacturer's corrective/preventative action system.The device labeling was updated, an urgent medical device correction notice (2916596-2/24/12-001-c) was issued on 02/23/2012, and a sealed outflow graft bend relief collar (sobr collar) was approved in a pma supplement and was implemented for use to secure the bend relief to the sealed outflow graft and increase the assemblys resistance to forces that would tend to dislodge the bend relief.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that during a pump exchange on (b)(6) 2016, it was observed that the outflow graft bend relief was disconnected from the pump.The pump exchange was performed using a subcostal approach.

Manufacturer Narrative

The explanted pump was returned; however, the sealed outflow graft, bend relief, and bend relief collar were not returned with the pump.A correlation between the device and the reported event could not be conclusively determined.The customer reported that during a subcostal pump exchange it was noted that the outflow graft bend relief was disconnected from the patient¿s pump.The explanted pump was returned for evaluation under medwatch mfr number #2916596-2016-02205; however, the sealed outflow graft and bend relief were not returned with the pump and the reported event could not be confirmed.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.

• 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 ; 6517564071
• MDR Report Key: 6097863
• MDR Text Key: 59771127
• Report Number: 2916596-2016-02205
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2916596-2/24/12-001-C
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 110