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

Model Number 106524US, 106524, 10652INT

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Hemolysis (1886)

Event Date 03/22/2018

Event Type  Injury  

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.

Event Description

A complaint trend was identified as possibly related to hm3 outflow graft obstruction due to twisting.These complaints were investigated as part of a capa since they documented persistent, post-operative low flows and reported outflow graft deformation potentially from a twist anywhere along the graft.These complaints were confirmed based on available data from reoperation with visualization or ct angiography, or through explant analysis confirming hm3 outflow graft obstruction due to postoperative twisting.

• 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7559380
• MDR Text Key: 109735745
• Report Number: 2916596-2018-02282
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US, 106524, 10652INT
• Device Catalogue Number: 106524US, 106524, 10652INT
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• 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): Death; Life Threatening; Required Intervention