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

Model Number 6900PTFX27

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned through implant patient registry that a 27mm 6900ptfx mitral valve was explanted after an approximate implant duration of six (6) years and two (2) months due to unknown reason.The explanted valve was replaced with a 27mm non-edwards prosthetic valve.The patient is a 50-year-old male with history of rheumatic heart disease s/p mvr (2010), s/p re-do mvr & avr (2016), nyha class i-ii heart failure, hypertension, dyslipidemia, complete heart block s/p ppm, paroxysmal atrial fibrillation on coumadin, pericarditis, copd/emphysema on continuous home oxygen, asthma, former smoker, type 2 diabetes, and obesity.

Event Description

It was learned through implant patient registry that a 27mm 6900ptfx mitral valve was explanted after an approximate implant duration of six (6) years and two (2) months due to prosthetic valvular leak, moderate systolic anterior motion, lvot obstruction, and trivial mr.The explanted valve was replaced with a 27mm non-edwards prosthetic valve.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6 corrected: b5, b7 the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16304778
• MDR Text Key: 308860913
• Report Number: 2015691-2023-10601
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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 Expiration Date: 01/27/2012
• Device Model Number: 6900PTFX27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/01/2023
• Date Device Manufactured: 01/27/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female