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

Model Number 2800TFX23MM

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Edwards received information that this bioprosthetic 23mm aortic valve, implanted approximately one (1) year and five (5) months, was explanted due to severe aortic insufficiency/regurgitation.A photograph was submitted with the reported event, depicting a torn leaflet.Structural valve deterioration was also reported by the physician.Operative observation found a "clean perforation" at the tip of the cusp that correlates to the noncoronary cusp and mild stiffening of the leaflets.The device was replaced with another 23 competitor's aortic valve, there were no complications patient complications reported.Per pathology observation post-surgery, it was reported the valve had leaflet with focal superficially adherent fibrin but without penetration of inflammation into the tissue.

Manufacturer Narrative

Method = device evaluation anticipated, but not yet begun.Additional manufacturer narrative: device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Attempts have been made to obtain additional information about the event and patient.Should additional details be received at a later date, a supplemental report will be submitted.

Manufacturer Narrative

Device evaluation: the device was returned for visual analysis.As received, a hole was observed on leaflet 1, measuring 7mm x 3mm.Multiple surface damages were observed on the outflow aspect of leaflet 3, which did not penetrate the entire thickness of the leaflet.Holes and damages were beveled at outflow aspect.Surface damage on leaflet 3 contacted host tissue overgrowth from the sewing ring while leaflet was in the open position.Minimal host tissue overgrowth encroached onto the tissue at the inflow aspect and into the orifice at the greatest point by approximately 4mm; it was minimal at the outflow aspect and into the orifice at the greatest point by approximately 2mm.Host tissue was moderate to heavy at stent inflow and minimal at stent outflow; it also fused leaflet 2 and leaflet 3 at commissure 3 by 1mm on the outflow aspect.Magnification of the perforation showed that the characteristics of the tissue gap and all of the non-transmural tissue damages are consistent with those caused by typical suture tail abrasion, which have distinct tissue damage pattern tapered towards the inflow side of the leaflets.Suture tail abrasion related to leaflet perforation is a common phenomenon in bioprosthetic hear valves in the aortic position where the bioprosthetic leaflets can come in contact with the long suture tail.Except for the suture tail abrasion related tissue damage, no other structural valve deterioration was evident on the valve as received.Method: x-ray.Additional manufacturer narrative: although no functional evaluation was performed, based on gross visual analysis, the suture tail abrasion related to leaflet tissue damage and perforation appears to be severe enough to have contributed to the severe insufficiency of this particular valve.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT® THEON RSR 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; lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4424561
• MDR Text Key: 5282616
• Report Number: 2015691-2015-00104
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2014
• Device Model Number: 2800TFX23MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2012
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 87