CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800TFX (REF 2800TFX23MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103177244), received between Sep 20, 2024 and Jan 3, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Chest Pain; Insufficient Information; Syncope/Fainting

  MAUDE report 21074442 ↗
• InjurySep 20, 2024Degraded; Degraded

  EDWARDS RECEIVED NOTIFICATION FROM PE RETROSPECTIVE STUDY (CHINA) THAT THIS 61-YEAR-OLD PATIENT WITH A 2800TFX23MM VALVE MODEL IMPLANTED IN AORTIC POSITION UNDERWENT REINTERVENTION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS AND SIX (6) MONTHS DUE TO STRUCTURAL DETERIORATION WHICH LED TO SIGNIFICANT LEAFLET OPENING RESTRICTION, SEVERE STENOSIS AND MILD REGURGITATION. VALVE WAS PERFORMING WITH A MEAN GRADIENT OF 63MMHG AND A VELOCITY OF 5.21M/S. THESE FINDINGS WERE DETECTED ON AN ULTRASOUND PERFORMED EIGHTEEN (18) DAYS BEFORE THE REINTERVENTION. AS REPORTED, PATIENT PRESENTED MAINLY WITH COUGH AND WHEEZING. A 24MM NON-EDWARDS TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE. PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY TEN AND WAS NOTED TO BE CURRENTLY IN A STABLE CONDITION.

  Patient problems: Cough; Wheezing

  MAUDE report 20264859 ↗