MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Fatigue (1849); Thrombus (2101)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 1 year, 2 months.The outflow graft is expected to be returned for analysis.It has not yet been received.The event occurred at (b)(6).The patient remains ongoing on lvad support.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) 2017, the patient was admitted to the hospital due to low flow alarms.The patient experienced fatigue and shortness in breath.An assessment and clinical investigation showed a potential proximal outflow graft thrombosis, accompanied by aortic valve opening and non-proper left ventricle unloading.A re-operation revealed a twisted outflow graft and thrombus formation between the outflow graft bend relief and the outflow graft.The outflow graft was exchanged and no further issues have been reported.No additional information was provided.

Manufacturer Narrative

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.

Manufacturer Narrative

The report of a twisted sealed outflow graft was confirmed based on images submitted by the account.Ct images submitted for review appeared to show a narrowing of the outflow graft near the graft hardware.Pictures of the outflow graft taken at the time of explant showed that the graft was twisted in the area of the narrowing.The normal tissue ingrowth on the exterior of the graft indicated that the twist had been present for a an undetermined period of time during support.The graft appeared to be twisted in the counter-clockwise direction.The exchanged sealed outflow graft was returned with the bend relief detached.Both the graft and the bend relief had been cleaned prior to return.The graft material still displayed some of the twist impressions that were visible in the submitted photos.Visual inspection of the graft around the twist found no tears or holes.The examination found no evidence of damage or wear to the graft attachment or bend relief attachment clip hardware.The occlusion caused by the observed twist could have contributed to the reported low flow alarms.The evaluation could not conclusively determine the cause of the twist.Similar incidences have been reported.A corrective action has been initiated to investigate the issue.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• 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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7148166
• MDR Text Key: 95832060
• Report Number: 2916596-2017-03336
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: LH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 71