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

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Organ Dehiscence (2502)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned to edwards for evaluation.Evaluation is in progress.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Ring 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 in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A manufacturing related issue was not identified.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that a 34mm mitral ring, implanted approximately for one (1) year and 10 months, was explanted due to dehiscent mitral ring with severe mitral regurgitation.The explanted device was replaced with a 29mm bioprosthetic valve.The patient developed a post op coagulopathy requiring blood clots.The patient became hemodynamically unstable immediately following the pump run and an intra-aortic balloon pump had to be placed.The patient returned to the icu in critical, but satisfactory condition.

Manufacturer Narrative

Device evaluation: customer report of dehiscence and regurgitation could not be confirmed through visual observations.As received, the ring exhibited minimal host tissue overgrowth and x-ray demonstrated ring intact.The sewing cloth had straight and even cuts at multiple locations around the ring; silicone cuts were observed underneath two of the three sewing cloth cuts.Sutures remained attached on the sewing ring.Multiple pieces of native tissues and suture threads were also returned along with device.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9071385
• MDR Text Key: 161415693
• Report Number: 2015691-2019-03449
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: 5200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR