MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS® PERIMOUNT MAGNA; HEART-VALVE, REPLACEMENT

Model Number 3300TFX21MM

Device Problem Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation, as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Failure of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis, non-calcific degeneration and/or endocarditis.Based on the information received, the most likely root cause is patient's clinical condition that contributed to this event.Of note, the patient's has had multiple sings of infection.A manufacturing non-conformance was not identified.There was no indication or allegation of a device malfunction contributing to the event.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Structural deterioration is listed as a potential adverse event in the ifu.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

It was reported via the implant patient registry that a 21mm bioprosthetic aortic valve, implanted for four (4) years and eight (8) months, was explanted due to aortic valve regurgitation and aortic stenosis.This (b)(6) year old male patient presented with an apparent infection in a prosthetic right knee three years post avr.He was found to have a strep mitis/oralis bacteremia with septic arthritis.He was treated appropriately with eventual resolution of his illness.Few months later, tee demonstrated an ejection fraction 65% with moderate aortic valve regurgitation and identification of 2 separate eccentric jets.There was no vegetation seen.Eight months after his resolved illness, he developed a dental infection which was treated.Following that he developed progressive shortness of breath and was extremely symptomatic.Follow-up tee demonstrated worsening aortic insufficiency.He has had negative blood cultures.Prior to his redo avr, he had an infected tooth pulled.He underwent redo avr with a 21mm 3300tfx valve, platelet gel application, dual catheter on-q pain pump insertion.Intraoperatively, the aorta was opened and the valve pathology was visualized.There was a 2mm hole in the right coronary leaflet and the adjacent left coronary leaflet had partially torn away from the supporting strut causing prolapse of this leaflet.Postoperatively, he was taken to the intensive care unit.On pod one, av paced with underlying bradycardia.A permanent pacemaker was placed on pod #2.On pod #6, he experience new afib and amiodarone was administered.He was later discharged home on pod#7.

• Brand Name: CARPENTIER-EDWARDS® PERIMOUNT MAGNA
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7508195
• MDR Text Key: 108037906
• Report Number: 2015691-2018-01813
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2017
• Device Model Number: 3300TFX21MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Date Device Manufactured: 04/26/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR