MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; VENTRICULAR (ASSISST) BYPASS

Model Number 105581US

Device Problems Material Puncture/Hole (1504); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

It was reported that in a new implant kit the outflow graft (ofg) bend relief was observed to have a hole in the outer layer.The hole was observed directly out of the box prior to the preparation of the pump.The facility did not have a stand-alone ofg so new implant kit was opened and ofg and bend relief was removed and used in implant.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted photo and returned outflow graft bend relief confirmed the reported damage; however, a specific cause for this finding could not be conclusively determined through this evaluation.The sealed outflow graft assembly, including the bend relief, was returned in like-new condition.Visual inspection of the outflow graft bend relief (ogbr) revealed a tear to the outer layer of ogbr material, approximately 2.75¿ from its hardware.The hardware of the outflow graft and ogbr were inspected and no abnormalities were observed.The tear was examined under a microscope, which revealed no damage to the underlying layers of the ogbr.Additional minor damage was observed 0.5¿ distal to the tear.Blue markings were observed approximately 0-0.25¿ proximal to the tear and 0-0.25¿ distal to the tear.This issue was forwarded to abbott manufacturing for further analysis.A quality document review found that the ogbr undergoes inspection at the vendor, abbott receiving inspection (ri), and abbott packaging.Furthermore, there are no sharp tools used during the packaging process.Packaging materials used are unlikely to have damaged the ogbr.There are sufficient inspection steps in place for when the bend relief is received from the supplier to when it is placed in the tray with the assembled graft for surface damage to be caught.Although a specific root cause for the observed outflow graft bend relief damage could not be conclusively determined through this evaluation, this does not appear to be a manufacturing-related issue.The relevant sections of the device history records for the outflow graft assembly, lot number 7558200 were reviewed and showed no deviations from manufacturing or quality assurance specifications.Additionally, a quality document review was performed.The bend relief undergoes inspection at the vendor, abbott receiving inspection (ri), and abbott packaging.The heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu) is currently available.Section 5 of this ifu contains instructions for unpacking the sealed outflow graft (5-15) and preparing the sealed outflow graft.Section 5 also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11458070
• MDR Text Key: 239706779
• Report Number: 2916596-2021-00847
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 7558200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1