MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; TISSUE, HEART-VALVE

Model Number 11060A

Device Problem Product Quality Problem (1506)

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

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As reported the 11060a valved conduit was noted to have accumulation of gelatin inside the terumo gelweave valsalva graft.The gelatin was removed, and the device was implanted.In this case, the root cause remains indeterminable at this time.The reported event has not been confirmed and the investigation is still in progress.The subject device is not available for evaluation, as it remains implanted in the patient.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that during a procedure, it was observed that the 25mm 11060a konect valved conduit had an accumulation of gelatin inside the graft.The gelatin was on the inside of the graft about 1/2 way down, opposite side from the surgeon.It was partially attached.The surgeon easily removed it with a nerve hook and continued with the implant.The removed gelatin was half the sized of a pencil eraser.There was some concerns and questions from the surgeon.Edwards representative contacted vascutek representative to obtain guidance and context regarding the issue, and the implant proceeded on fine.The gelatin was not saved and no photos were taken.Per the operative report, post procedure tee showed a good functioning aortic valve.  the operative report was received; however, it does not document that an accumulation of gelatin was observed and removed.

Manufacturer Narrative

As reported the 11060a valved conduit was noted to have accumulation of gelatin inside the terumo gelweave valsalva graft.The gelatin was removed, and the device was implanted.In this case, the root cause remains indeterminable at this time.Investigation is limited because the product was not returned, no images were provided, and the medical records do not document that an accumulation of gelatin was observed and removed.The reported event has not been confirmed and the investigation is still in progress.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10587843
• MDR Text Key: 208753621
• Report Number: 2015691-2020-13727
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR