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

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 05/19/2023

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.The device was not returned for evaluation, as device request is ongoing.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 via implant patient registry that a 27mm aortic valve was explanted and replaced with a 27mm valved conduit after an implant duration of 3 years, 2 months due to unknown reasons.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

H10: additional manufacturer narrative: updated sections b5, b7, h6 (impact code, clinical code, device code, and type of investigation).

Event Description

It was learned via implant patient registry that a 11500a 27mm aortic valve was explanted and replaced with a 11060a 27mm valved conduit after an implant duration of 3 years, 2 months due to valve thrombosis and type a aortic dissection.Per medical records, the patient developed valve thrombosis about 8 months post avr and ever since, he was placed on warfarin.During routine outpatient imaging, it was incidentally found that the patient had type a aortic dissection with flaps involving the aortic root and distal ascending aorta.The dissection flap extends into the left main coronary artery with severe stenosis.The patient underwent redo avr, ascending aorta and aortic root replacement using a 27-mm 11060a konect resilia aortic valved conduit, and transverse arch replacement using a 30-mm, graft.Intraoperavely, the 27mm 11500a inspiris resilia aortic valve had evidence of leaflet thrombosis at their bases.The 27mm 11060a aortic valved conduit was competent with good coronary flow and no complications.After surgery, the patient was transferred in stable condition intensive care unit.The patient was discharged on pod #8.

Manufacturer Narrative

The most likely cause is patient factors.

• 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: 17443909
• MDR Text Key: 320237381
• Report Number: 2015691-2023-14992
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)210206
• 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,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• 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: 78 YR
• Patient Sex: Male