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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional narratives: surgical / percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.H3: product evaluation.Customer reports of stenosis and calcification were confirmed.The x-ray demonstrated commissure 1 was bent outward and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated calcification nodules on leaflet 1.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm on leaflet 3 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 1 at the outflow aspect.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect.Host tissue overgrowth and calcification restricted leaflet mobility and led to stenosis.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 reported that a 21mm aortic valve was explanted after an implant duration of 1 year, 9 months due to severe stenosis and calcification.A 21mm valved conduit was implanted in replacement.As reported the alleged valve seemed to be structurally intact, with free moving leaflets on non-coronary and right coronary cusps while calcification was noted at base of left coronary cusp.Per product evaluation moderate pannus, minimal calcification, and stenosis were confirmed.

Manufacturer Narrative

H10: additional narratives: updated b5, b7, and h6 per new information received.

Event Description

It was reported and later learned through investigation that a 11500a 21mm aortic valve was explanted after an implant duration of 1 year, 9 months due to severe stenosis caused by moderate host tissue overgrowth and minimal leaflet calcification.The patient presented with dyspnea on exertion and dizziness.A 11060a 21mm valved conduit was implanted in replacement.As reported the alleged valve seemed to be structurally intact, with free moving leaflets on non-coronary and right coronary cusps while calcification was noted at base of left coronary cusp.Per product evaluation, host tissue overgrowth and calcification restricted leaflet mobility and led to stenosis.The submitted echo images confirm the absence of extensive calcification of the bioprosthesis leaflets.Anatomically, bioprosthesis leaflet opening appears to be moderately and symmetrically reduced; it is possible that this degree of anatomic narrowing could have resulted in more significant (severe) hemodynamic aortic stenosis, but this cannot be confirmed in the absence of spectral doppler hemodynamic interrogation.Although no soft-tissue-density masses suggestive of pannus are visualized in association with the bioprosthesis, echocardiography (including tee) has poor sensitivity for the visualization of pannus, and its presence cannot be excluded.

Manufacturer Narrative

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.

Manufacturer Narrative

H10: additional narratives updated h6 per new information received the most likely cause is patient factors, including history of coronary artery bypass graft (cabg) and history of bicuspid valve.

• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17493199
• MDR Text Key: 320751428
• Report Number: 2015691-2023-15137
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)250505(11)210506217799372
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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: 47 YR
• Patient Sex: Female