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

Model Number 4450

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Mitral Insufficiency (1963); Mitral Regurgitation (1964); Rupture (2208)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted device was received at edwards lifesciences and an evaluation of the product is currently pending.A supplemental report will be submitted upon completion.

Event Description

(b)(4).In this case, edwards received information that this 30mm annuloplasty ring was explanted after four (4) years, three (3) months due to severe mitral insufficiency, secondary to dehiscence.As reported, the native mitral valve had ruptured chordae in two (2) places; one (1) at the confluence of the p1-p2 area and the second at the confluence of the p2-p3 region.This lead to significant eccentric mitral regurgitation near the p2 scallop.Therefore, the ring was excised and the native mitral valve was replaced with a 29mm pericardial bioprosthesis.There were no reported complications and the patient was later discharged on pod #17.

Manufacturer Narrative

Ring dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease and is typically unrelated to a device malfunction.In this case, the explanted device was not returned to edwards for analysis because it was discarded at the hospital.At this time, edwards is unable to conclusively determine the root cause for this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.The annuloplasty ring was initially reported as received at edwards for analysis.It was later learned the hospital returned an unrelated device and this annuloplasty ring was discarded at the hospital.

• 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: mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5304518
• MDR Text Key: 34378926
• Report Number: 2015691-2015-03405
• 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: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 4450
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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 Age: 75 YR
• Patient Weight: 77