MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II RING; ANNULOPLASTY RING

Model Number	5200M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the implant patient registry that a 36mm mitral ring, implanted for four (4) years and six (6) months, was explanted due to severe 4+ insufficiency.The patient presented with dizziness and occasional palpitations.The explanted device was replaced with a 25mm bioprosthetic valve.The patient was discharged home in good condition on pod #6.The implantation data card indicated that the device explant was due to deficiency of the original device.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.
Additional Manufacturer Narrative
The causes of re-operation or percutaneous intervention for failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.The device was not returned for evaluation, as device request is still 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.
Additional Manufacturer Narrative
H10: additional narratives updated b5 corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was reported via the implant patient registry that a 36mm mitral ring, implanted for four (4) years and six (6) months, was explanted due to severe 4+ insufficiency.The patient presented with dizziness and occasional palpitations.The explanted device was replaced with a 25mm bioprosthetic valve.The patient was discharged home in good condition on pod #6.Per or finding : very redundant tissue along the posterior leaflet of the mitral valve.There was stretching of the cords to the p3 which was not present at the first operation.The p2 repair was intact.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II RING
• Common Device Name: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13904711
• Report Number: 2015691-2022-04616
• Device Sequence Number: 14469509
• Product Code: KRH
• UDI-Device Identifier: 00690103180237
• UDI-Public: (01)00690103180237(17)220430
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K083470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5200M
• Device Catalogue Number: 5200M36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female