CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
Report
- Report Number
- 2015691-2026-10211
- Event Type
- Injury
- Date Received
- January 6, 2026
- Report Date
- March 12, 2026
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: 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.
ADDED INFORMATION TO D4, H6. CUSTOMER REPORT OF PVL WAS UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. CUSTOMER REPORT OF STENOSIS WAS CONFIRMED THROUGH OBSERVED HOST TISSUE OVERGROWTH. HOST TISSUE OVERGROWTH RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. PARAVALVULAR/PERIVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE SEWING RING OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE DUE TO AN INSUFFICIENT SEAL OF THE VALVE TO THE ANNULUS. 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 DURING IMPLANTATION, SUCH AS INCORRECT VALVE SIZING, HAVE BEEN SHOWN TO CONTRIBUTE TO THE DEVELOPMENT OF PVL. ANATOMICAL FACTORS MAY ALSO 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. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PANNUS IS A NON-IMMUNE INFLAMMATORY REACTION OF THE BODY TO THE IMPLANTED PROSTHESIS, CHARACTERIZED BY PROLIFERATION OF FIBROELASTIC TISSUE AND COLLAGEN, WITH A STARTING POINT IN THE SUTURE AREA AND SUBACUTE OR CHRONIC CENTRIPETAL EVOLUTION. PANNUS CAN HAVE BOTH BENEFICIAL AND HARMFUL EFFECTS DEPENDING ON THE AMOUNT OF GROWTH AND LOCATION. A SMALL AMOUNT OF HOST TISSUE GROWTH OVER THE SUTURE LINE IS EXPECTED AND IS NEEDED TO FORM A NON-THROMBOGENIC SURFACE AND COMPLETE THE HEALING PROCESS AFTER DEVICE IMPLANTATION. IN CONTRAST, AN EXCESSIVE AMOUNT OF PANNUS GROWTH CAN CAUSE NONSTRUCTURAL DYSFUNCTION THAT MAY REQUIRE INTERVENTION. HOST TISSUE GROWTH CAN EXTEND ONTO THE CUSP SURFACES LEADING TO THICKENING OF THE CUSPS, CUSP RETRACTION OR CURLING, LEAFLET IMMOBILITY, AND/OR ABNORMAL COAPTATION, POTENTIALLY RESULTING IN VALVULAR REGURGITATION, ELEVATED GRADIENTS, AND/OR STENOSIS. PANNUS/HOST TISSUE OVERGROWTH IS MOST LIKELY DUE TO PATIENT FACTORS AND IS UNLIKELY TO BE RELATED TO A MANUFACTURING NON-CONFORMANCE. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS.
H11. ADDITIONAL NARRATIVE. UPDATED H3 AND H6. H3: PRODUCT EVALUATION. CUSTOMER REPORT OF PVL WAS UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. CUSTOMER REPORT OF STENOSIS WAS CONFIRMED THROUGH OBSERVED HOST TISSUE OVERGROWTH. X-RAY DEMONSTRATED WIREFORM INTACT AND MINIMAL CALCIFICATION ON LEAFLETS 2 AND 3. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 8MM ON LEAFLET 2 AT THE INFLOW ASPECT. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 5MM ON LEAFLET 3 AT THE OUTFLOW ASPECT. HOST TISSUE FUSED LEAFLETS 1 AND 2 BY APPROXIMATELY 5MM AT COMMISSURE 2 ON THE OUTFLOW ASPECT. HOST TISSUE OVERGROWTH RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. HOST TISSUE OVERGROWTH ON THE STENT CIRCUMFERENCE WAS MODERATE AT BOTH THE INFLOW AND OUTFLOW ASPECTS. LEAFLET 1 HAD A PERFORATION OF APPROXIMATELY 5MM X 3MM. THE PERFORATION WAS BEVELED AT THE OUTFLOW ASPECT, A TYPICAL CHARACTERISTIC OF THOSE CAUSED BY SUTURE TAIL/FASTENER ABRASION. SUTURES REMAINED ATTACHED AROUND THE SEWING RING OF LEAFLET 1 ON THE OUTFLOW ASPECT. SEWING RING CLOTH WAS CUT IN MULTIPLE AREAS AROUND THE VALVE EXPOSING THE METAL BAND AND THE WIREFORM.
IT WAS REPORTED THAT A 23MM 3300TFXJ AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY NINE (9) YEARS AND SEVEN (7) MONTHS DUE TO SEVERE PARAVALVULAR LEAK (PVL) AND AORTIC STENOSIS. THE PATIENT PRESENTED WITH MILD SYMPTOMS INCLUDING FATIGUE AND DYSPNEA ON EXERTION. THE EXPLANTED DEVICE WAS REPLACED WITH A NON-EDWARDS PROSTHETIC VALVE. THE PATIENT'S OUTCOME WAS REPORTED AS 'RECOVERED.' ACCORDING TO THE REPORTED INFORMATION, THE INITIAL AVR FOR SEVERE AORTIC REGURGITATION WAS PERFORMED CONCOMITANT WITH MITRAL AND TRICUSPID ANNULOPLASTY. ANATOMICAL FINDINGS REVEALED A FRAGILE AORTIC ANNULUS AROUND THE RCC AREA. FOLLOWING DEVICE IMPLANTATION, A MODERATE PVL ORIGINATING FROM THE RCC AREA WAS IDENTIFIED. THE AORTA WAS RE-CLAMPED, AND THE ANNULAR TISSUE WAS FOUND TO BE TORN OVER A LENGTH OF ABOUT THREE STITCHES. THE SURGEON JUDGED THAT SIMPLE RE-SUTURING WOULD LIKELY RESULT IN FURTHER TEARING. CONSEQUENTLY, THE AORTIC ROOT AROUND THE RCC AREA WAS ELEVATED TO THE LEVEL OF THE ANNULUS, AND THREE MATTRESS SUTURES WITH FELT PLEDGETS WERE PLACED FROM THE OUTSIDE OF THE AORTIC WALL TOWARD THE CUFF OF THE DEVICE. POST-OPERATIVE TTE STILL DETECTED MILD-MODERATE PVL ORIGINATING AROUND THE RCC-NCC COMMISSURE, AND THE SEPTUM WAS SLIGHTLY HYPOKINETIC. UNDER REGULAR FOLLOW-UP WITH TTE, PVL PROGRESSED ANNUALLY IN THE THREE YEARS PRIOR TO REINTERVENTION FROM MILD TO MODERATE AND THEN SEVERE. THE SURGEON CONSIDERED THAT HYPERTROPHIC SEPTUM CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33516 | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 3300TFXJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| L| R |