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

Model Number 11500A23

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/23/2023

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.

Event Description

It was learned through implant patient registry and investigation, that a patient with a 23mm inspiris aortic valve was explant at implant due to obstruction of lad/circumflex artery.The device was replaced with a 21mm 11500a valve.Per medical records the patient initially underwent avr with a 23mm edwards inspiris valve for native as and ai.The valve was implanted and appeared to seat easily in the annulus but one of the struts of the valve was noted to be looped by the valve suture.The 23mm edwards valve was explanted ((b)(6) 2023) and replaced with a 23mm inspiris valve.The valve was inspected, and the lad/circumflex was obstructed by the strut adjacent to the left right commissure.It was elected to explant the 23mm inspiris valve replacing with a 21mm inspiris valve and graft the lad and circumflex arteries.Impella was placed due to poor lv function.Placement of impella was difficult due to the small size of the patients heart and it could not be positioned adequately leading to severe ai.It was elected to withdraw the impella device.Following removal of the impella, there was no transvalvular or perivalvular insufficiency.The patient oxygenation continued to deteriorate followed by lv failure.The patient was transferred to cvicu with a va ecmo and open chest.It was later learned that the patient expired on pod#2.This case involved a 69-year-old male with history of severe bicuspid av stenosis.

Manufacturer Narrative

H10: additional manufacturer narrative: valve explant at implant is typically a result of inappropriate sizing, difficulty seating, distortion of the valve, valve displacement before/after frame expansion, and/or the patients anatomy, and not a malfunction of the device.The most likely cause is procedural factors, including the valve explanted was inadequate with regard to the patient's anatomy leading to an obstruction of the lad/circumflex artery.

• Brand Name: EDWARDS 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17871199
• MDR Text Key: 324927490
• Report Number: 2015691-2023-16526
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)270215(11)2302162110048232
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female