MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number 3000TFX

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Death (1802); Mitral Regurgitation (1964)

Event Date 12/13/2018

Event Type  Death  

Manufacturer Narrative

Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.There are technique and anatomical related factors that can contribute to the development of pvl.In this case, it was noted that the valve was well-seated.There was no valvular damage or perivalvular gaps seen.There was no clear area of leak.The root cause of this event cannot be determined with the available information.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.(b)(4).Please reference mfr report #2015691-2019-00523 for the 27mm edwards valve also used in this case.

Event Description

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.In this case, it was learned that a 3000tfx 27mm aortic valve was explanted at implant due to perivalvular leak secondary to sizing issues.Per the operative report, this patient presented with significant aortic stenosis and minimal mitral regurgitation with an ef of 44%.Initially, redo-cabg x2 was performed.During the avr, the native aortic valve was trileaflet with a heavily calcified annulus.The valve was implanted and noted to be well-seated; however, echo revealed a significant perivalvular leak.Severe wide open mitral regurgitation was also noted.The patient was placed back on bypass and the valve was examined.There was no valvular damage and no perivalvular gaps seen.Despite finding no clear area of leak, the valve was explanted and new sutures were placed.A 3000tfx 25mm valve (subject device) was placed with no obvious technical issues.However, re-pressurizing the root resulted in identical echo findings.The cause of the perivalvular leak could not be identified.Cardiopulmonary bypass was eventually discontinued after an iabp was placed, which transiently improved the mitral regurgitation and lv function.A continued decompensation with progressive lactic acidosis was documented.This was with maximal inotropic support, no inhalation and iabp.After consolation, the family wished to avoid another bypass run or ecmo.Pacing was discontinued and the patient was declared dead.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8346284
• MDR Text Key: 136443522
• Report Number: 2015691-2019-00524
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: 3000TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91