MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING

Model Number 4100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/12/2013

Event Type  Injury  

Event Description

In this case, it was reported this bioprosthetic valve was explanted after an implant duration of approximately seven (7) months.Through follow up with the health care provider, it was learned that the reason for explant due to mitral regurgitation, secondary to dehiscence.The patient was transferred to the cardiovascular intensive care unit (cvicu) in stable condition.There were no adverse effects reported as a result of the re-operation.

Manufacturer Narrative

(b)(4).The explanted device was returned to edwards for analysis.As received, the ring exhibited minimal host tissue overgrowth.Suture threads were evident in the sewing ring.No visible damage to band was observed in the x-ray.Based on the product evaluation, we are unable to confirm the clinical observation.Ring or valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair or prosthetic valve implantation in combination with friable myocardial tissue.In this case, the health care provider claimed that the dehiscence was not due to a device malfunction nor quality deficiency.No further actions are possible with the available information.

• Brand Name: CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL 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: 3627583
• MDR Text Key: 4131362
• Report Number: 2015691-2014-00347
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2014

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 Expiration Date: 03/31/2015
• Device Model Number: 4100
• Device Lot Number: R-10D1013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2010
• 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: 72 YR