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

Model Number 4450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Corneal Pannus (1447)

Event Date 02/13/2014

Event Type  Injury  

Event Description

Edwards received information that a 30mm annuloplasty ring was explanted twelve (12) years after implant.It was reported that the patient's mitral valve was distorted with pannus formation between a dehisced ring and the mitral valve, entrapping the posterior leaflet.The device was removed, the anterior leaflet of the native mitral valve was resected (posterior leaflet left intact) and a 27mm pericardial bioprosthetic valve was implanted.The patient was taken to the icu in stable, but critical condition.

Manufacturer Narrative

(b)(4).Device not returned.The explanted device was not returned to edwards for analysis.However, the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Without return of the device, edwards is unable to confirm the clinical observation.Ring dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Reoperations are primarily the result of a progression of disease, the patient's baseline hemodynamics, or technical failures and are not evidence of product malfunctions.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• 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: 3746144
• MDR Text Key: 4221977
• Report Number: 2015691-2014-00854
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2014

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
• Device Operator: Health Professional
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/11/2014
• 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: 70 YR