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

Model Number 106524

Device Problems Detachment Of Device Component (1104); Nonstandard Device (1420)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.(b)(4).Approximate age of device - 11 months.Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014.Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware.A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable.As a corrective action, consignees have been notified of the potential occlusion due to twisting.Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation.The patient remains on lvad support.No additional 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) on (b)(6) 2017.It was reported that review of recent chest x-rays revealed a possible outflow graft bend relief separation.There was no reported adverse patient impact due to the event.No additional information was provided.

Manufacturer Narrative

The review of the post-op x-rays of the lvad, revealed that the sealed outflow graft bend relief may not be fully engaged.These x-rays appear to show the bend relief hardware tilted out of alignment with respect to the sealed outflow graft hardware, indicating that the bend relief was not attached.The evaluation could not conclusively determine a root cause for the disconnected outflow graft bend relief.The patient was implanted after the corrective action implemented to address the heartmate 3 sealed outflow graft bend relief disconnection issue.The patient remains ongoing and no additional events have been reported at this time.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.

• 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
• MDR Report Key: 7657458
• MDR Text Key: 113285061
• Report Number: 2916596-2018-02598
• Device Sequence Number: 0
• Product Code: DSQ
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 6016077
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 100