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

Model Number 11500A

Device Problem Malposition of Device (2616)

Patient Problem Laceration(s) (1946)

Event Date 12/09/2022

Event Type  Injury  

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 patient anatomy, and not a malfunction of the device.There may be cases in which regurgitation is detected by tee prior to the completion of the surgical case and exchange of the valve is required.The device was not returned for evaluation, as it was discarded.The most likely cause is procedural factors, including insufficient debridement of calcification along the sinotubular junction (stj).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.

Event Description

It was learned via the implant patient registry that a 23mm aortic valve was explanted at implant due to seating difficulty.The explanted device was replaced with a 23mm valve.Per medical records the patient presented with symptomatic as and cad, and underwent avr, annular enlargement, aortic patch reconstruction using bovine pericardium, cabg x 2, and laa ligation.The native av was found to be trileaflet with dense calcific disease and a large amount of calcium along the stj as well as the ascending aorta.Portions of calcium which were protruding into the ascending aorta were debrided, the aortic annulus was debrided.Upon implant of the 23mm inspiris valve, there was significant difficulty parachuting the valve into position because of the stj calcium and it was noted upon further inspection that the stj calcium had torn and started to cause a dissection over the left main coronary artery.The valve was explanted to better visualize the area for repair.The tear was debrided of calcium and repaired with sutures.The rest of the st j was inspected and the decision was then made to cut across the st j into the non-coronary cusp and partially into the annulus in order to accommodate valve placement given that the aorta was starting to tear in multiple areas due to friable tissue.A new 23mm lnspiris valve was seated into position.Tee examination of the aortic prosthesis demonstrated a well-functioning 23mm lnspiris aortic bioprosthesis, well-seated with no pvl.A ppm was implanted on pod #4 for chb.The patient was discharged home on pod #9.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Manufacturer Narrative

The most likely cause is procedural factors, including insufficient debridement of calcification along the sinotubular junction (stj).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.

• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16480255
• MDR Text Key: 310648081
• Report Number: 2015691-2023-11232
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)260831(11)220901219479516
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue 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: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 68 YR
• Patient Sex: Female