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

Model Number 280025MM

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Stenosis (2263)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The device was not returned for evaluation, as it remained implanted.Based on the available information, the root cause of the event was likely due to patient related factors and the progression of the patient's underlying valvular disease pathology.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a model 25mm pericardial aortic valve was disabled via a valve-in-valve procedure after an implant duration of 11 years, 5 months due to stenosis.A 26mm transcatheter valve was implanted successfully.The patient tolerated the procedure well and was transferred to the icu in stable condition.The patient was discharged home in stable condition on post-operative day two.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7768799
• MDR Text Key: 116626005
• Report Number: 2015691-2018-03287
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: 280025MM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR