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

Model Number 11500A25

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem Dyspnea (1816)

Event Date 12/29/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that this inspiris resilia valve model 11500a25 was explanted from the aortic position after an implant duration of 3 years and 5 months due to leaflet holes.The valve was implanted via full sternotomy approach.Echo post op, 3 years ago was normal.On explant, holes were observed on the leaflets.The sutures matched the holes at the time of explant.Threads were observed close to the holes.Upon examination it was concluded that the holes were due to the use of the corknot device at implant.As reported, the holes were not discovered before because the holes enlarged progressively with time.The patient presented with short of breath before the procedure.A 29mm edwards valve was successfully implanted in replacement.All went well without complications and the patient was discharged home on pod #5.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Customer report of leaflet hole was confirmed through image evaluation.Three color photos were provided of implanted valve from the outflow aspect.All three leaflets had multiple holes that were beveled at the outflow aspect, a characteristic typical of suture tail/fastener abrasions.Multiple suture fasteners were attached all around the valve sewing ring.One of the opened leaflets appeared torn from the inflow aspect and a suture fastener end was visible through the hole.If the surgeon does not cut sutures close to the knot, excess suture tails may result in abrasion, perforation, or damage to the leaflet.This may require an exchange of the device.The subject device was not available for evaluation.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.

Event Description

New information was received through review of medical article moth-eaten like impact of automated titanium fasteners on aortic valve bioprosthesis: a word of caution.Edwards received notification that an inspiris resilia valve model 11500a25 was explanted from the aortic position after an implant duration of three (3) years and five (5) months due to leaflet holes.The valve was implanted via full sternotomy approach.Echo post op and follow-up echo three (3) months post op were normal with no gradient nor regurgitation.However, at the four (4) months follow-up echo, first signs of central aortic regurgitation were noted.Four months and one year after surgery mild transvalvular aortic regurgitation, two years after surgery moderate, three years after surgery moderate to severe and three and a half years after surgery severe aortic regurgitation was observed.On explant, holes were observed on the leaflets.The sutures matched the holes at the time of explant.Threads were observed close to the holes.Upon examination it was concluded that the holes were due to the use of automated titanium fasteners at implant.As reported, the holes were not discovered before because the holes enlarged progressively with time.The patient presented with short of breath before the procedure.Another edwards valve was successfully implanted in replacement.All went well without complications and the patient was discharged home on pod #7.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13391175
• MDR Text Key: 284994620
• Report Number: 2015691-2022-03709
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)200131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A25
• Device Catalogue Number: 11500A25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male