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

Model Number	11060A
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gelweave valsalva graft is made of woven polyester, which has been impregnated with gelatin.The gelatin serves in place of fibrin, which seals the polyester prosthesis during normal pre-clotting.If excess gelatin mass were to accumulate inside the graft, this could lead to embolization, resulting in a partial or total blockage of blood flow in an affected vessel.The severity of harm would depend upon the location of the emboli.Cerebral arteries were involved, stroke may occur or peripheral embolism to a 3-5mm blood vessel.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that a 29mm valved conduit had gel-like debris inside the graft after implant.Per rep the graft immersed in saline for 5 minutes.The graft did not dry out after immersing in saline prior to implant.The debris was seen by surgeon and removed using a sucker.The product was in the rep's inventory and kept in proper conditions.The surgical team could clearly scrape the debris off and were using the sucker tip to remove anything they could see.It was noticed on both parts of the graft.Per medical records the patient presented with ascending aortic aneurysm, aortic insufficiency, and underwent bentall procedure.The echo reviewed valve working normally.The patient was discharged home in good condition on pod #4.
Additional Manufacturer Narrative
Based on the information available, the complaint of gel-like debris is confirmed by product evaluation, however, a manufacturing non-conformance could not be confirmed as the returned fragment would have passed visual inspections during manufacturing.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were 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.
Additional Manufacturer Narrative
Customer report of gel-like debris was confirmed.Returned valsalva graft fragment had traces of blood residue and was approximately 5cm long in its as received un-stretched state.A clear, gel-like particulate approximately 3mm long was observed on the outer folds of the graft.No other visible inconsistencies were observed from returned graft.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15003324
• Report Number: 2015691-2022-06751
• Device Sequence Number: 13836532
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)231013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11060A
• Device Catalogue Number: 11060A29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 09/16/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/09/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Unknown