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

Model Number 11500A

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional 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

It was learned through implant patient registry and investigation that a 27mm 11500a aortic valve was explanted after an implant duration of 2 years, 3 months due to valve dehiscence and severe large perivalvular leak.The explanted valve was replaced with a 25mm 11060a aortic valved-conduit.Per medical records, the patient presented with acute systolic heart failure secondary to paravalvular aortic insufficiency and underwent a redo avr and redo total aortic root replacement.Intraoperatively the aortic valve had completely separated from the aortic annulus and is free-floating with a large peri-graft hematoma.Essentially previous repair had completely dehisced.There was a huge inflammatory rind around the graft and valve.The tissue around the true aortic annulus was in reasonable condition.Multiple pledgeted sutures were placed in the annulus and a 25mm 11060a aortic valved-conduit was implanted with graft reconstruction of both coronary arteries.Post repair the avc was well-seated with no evidence of periprosthetic insufficiency.The patient was separated from bypass, coagulopathy was extensive as there were multiple areas of inflamed tissue.The patient tolerated the procedure well, after hemostasis was achieved, he was transferred to the cardiovascular recovery unit in serious but stable condition.

Manufacturer Narrative

Device dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.The root cause of this event was determined to be due to patient related factors, including the patient's friable tissue.The event in this case was impacted by the progression of the patient's underlying valvular disease pathology with nonstructural dysfunction.The subject device is not available for evaluation as it was discarded.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.There was no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.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.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18186600
• MDR Text Key: 328737835
• Report Number: 2015691-2023-17661
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)241001(11)201002217191726
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 78 KG