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

Model Number 6900P

Device Problems Torn Material (3024); Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) - dropped leaflet.Evaluation summary: the explanted device was returned to edwards for analysis.As received, minimal to moderate host tissue overgrowth encroached onto the tissue and into the orifice on a leaflet at the inflow and outflow aspects.Host tissue on the stent circumference was minimal to moderate at the inflow and outflow aspects.Tissue was observed thickened and swollen at the free margin of all three (3) leaflets near the commissures and in the cusp region of one (1) leaflet.Another leaflet had a tear near the commissure; tissue swelling was noted near the tear.There was an observed gap in the central coaptation region and the x-ray demonstrated an intact wireform intact and a bent commissure.Incidental findings: a hematoma was observed on a leaflet at the outflow aspect and the sewing ring was cut around the same leaflet.Method: light source performance evaluation.Result: dropped, torn leaflet.Conclusion: pending further evaluation.Additional manufacturer narrative: the clinical report of a dropped and torn leaflet could be confirmed and the probable cause of the regurgitation was likely due to leaflet tear.Additionally, host tissue along with thickened and swollen tissue restricted leaflet mobility and led to stenosis.Further observational evaluation of the device is currently underway and a supplemental report will be submitted upon completion.

Event Description

Edwards received information that this mitral bioprosthetic valve was explanted after five (5) years, five (5) months due to mitral regurgitation secondary to a dropped leaflet.Upon examination, a leaflet appeared to have torn from the stent post.A 31mm bioprosthetic valve was implanted in replacement, the tricuspid valve was repaired with an annuloplasty ring, and there were no reported complications.

Manufacturer Narrative

Evaluation summary (additional): during the examination of the valve, cauterizing marks were observed on the sewing areas of both inflow and outflow sides, which were presumably resulted from the explant; tissue tear was observed on one (1) leaflet near the commissure, leading to the prolapse of the leaflet in air.Tissue in the area near the commissural areas, particularly in the area with tear, became noticeably thickened and opaque; x-ray radiography revealed a small calcification nodule in the cusp of another leaflet and several very small calcification nodules were observed in the other two (2) leaflets; no appreciable tissue calcification was evident in the area with tear; these findings suggest that the leaflet tear was most likely related to the non-calcific bioprosthetic tissue degeneration.Conclusion: # human factors issue.The clinical report of a dropped and torn leaflet could be confirmed and the probable cause of the regurgitation was likely due to leaflet tear; additionally, host tissue along with thickened and swollen tissue restricted leaflet mobility and led to stenosis.The prolapse of the leaflet apparently resulted from the non-calcific tissue degeneration mediated leaflet tear that led to the reported mitral regurgitation in vivo; non-calcific tissue degeneration is one of the common chronic failure modes for this type of bioprosthesis.The underline mechanism of non-calcific tissue degeneration in bioprosthetic heart valve is still not fully understood, it is generally believed that the operational mechanical stress and patient biological factors are the major contributors to this type of non-calcific bioprosthetic tissue degeneration; the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.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: mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5005238
• MDR Text Key: 23088032
• Report Number: 2015691-2015-02058
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860057/S016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6900P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 47 YR