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

Model Number 106524INT

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 2 years and 1 month.(b)(6).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 lvad remains implanted in the patient but is not in use.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 (lvad) on (b)(6) 2016.It was reported that on (b)(6) 2018, a re-exploration of the lvad was performed due to frequent low flow alarms despite optimization of treatment.During re-exploration, a twist at the end of the outflow graft was found.After de-rotation of the outflow graft, the pump parameters normalized.The patient was reportedly stable and doing well.No additional information was provided.

Manufacturer Narrative

No product was returned for evaluation.The pump remains implanted and the patient remains ongoing on vad support.A specific cause for the reported outflow graft twisting could not be determined.Although the reported low flow alarms and outflow graft twist could not be confirmed, it should be noted that the twist could have contributed to low flow alarms.A direct correlation between the reported events and heartmate 3 lvas could not be conclusively established through this evaluation.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.A review of the device history records revealed that the device met applicable specifications.No further information is available.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: 7588643
• MDR Text Key: 110677783
• Report Number: 2916596-2018-02160
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 106524INT
• Device Catalogue Number: 106524INT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 45