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

Model Number 6900P27MM

Device Problem Torn Material (3024)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Edwards received information that this (b)(6) male underwent mitral valve replacement after an implant duration of nine (9) years, seven (7) months.Through obtained medical records, the reason for explant was due to severe prosthetic valve mitral regurgitation."[the patient] was found to have severe mitral regurgitation that looked like he had a flail mitral leaflet.Given the fact that [the patient] had had a previous mitral valve replacement, this likely represented a tear of the leaflet along one of the posts." upon visualization of the mitral valve, "the patient's mitral valve did have 1 torn leaflet along the posts." this was excised and replaced with a 29mm magna mitral ease pericardial bioprostheses (7300tfx).Post-operatively, there was no perivalvular leak of the mitral valve.No additional details provided.

Manufacturer Narrative

Additional manufacturer narrative the explanted device is anticipated for return to edwards and an evaluation of the product is currently pending its arrival.A supplemental report will be submitted upon completion.

Manufacturer Narrative

Evaluation summary: the explanted device was returned to edwards for analysis.As received, one (1) leaflet exhibited a tear.Thickened and swollen tissue was observed on all three (3) leaflets at all three (3) commissures.Minimal calcification was observed in the cusp areas of two (2) leaflets and was confirmed via x-ray.Host tissue was minimal to moderate and encroached onto the tissue at the outflow aspect, the stent inflow, and the stent outflow.Incidental findings: what appeared to be mold was observed on the inflow aspect of one (1) leaflet and at various locations on the sewing ring.The wireform of a commissure was distorted; these damages are likely due to implant or explant.Method: x-ray.Results:torn leaflet.The probable cause for explant could be confirmed as the returned device exhibited a tear in the leaflet, likely leading to the reported clinical observation of regurgitation.Leaflet tears and leaflet disruptions occurring over time are a form of structural valve deterioration that may ultimately result in significant regurgitation requiring replacement of the valve.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: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• 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; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4323964
• MDR Text Key: 5208457
• Report Number: 2015691-2014-02956
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2008
• Device Model Number: 6900P27MM
• Device Lot Number: KF7717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2004
• 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: 62 YR