SEE H11
Report
- Report Number
- 2015691-2025-09113
- Event Type
- Death
- Date Received
- November 6, 2025
- Date of Event
- March 20, 2025
- Report Date
- December 23, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- SEEH11
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INFORMATION ADDED/UPDATED TO SECTION H6 (INVESTIGATION FINDINGS, AND INVESTIGATIONS CONCLUSIONS). CORRECTED DATA IN SECTION H6 (DEVICE CODE): 1153 (DEGRADED) REPLACES 1069 (BREAK) AND 4056 (THICKENING OF MATERIAL). ADDITIONAL H6 (TYPE OF INVESTIGATION) CODE: LABELLING REVIEW. UPDATED DEVICE EVALUATION: CUSTOMER REPORT ISSUE WITH LEAFLET AND REGURGITATION WAS CONFIRMED DUE TO OBSERVED LEAFLET TEARS IN THE AS RECEIVED CONDITION. AS RECEIVED, WHAT APPEARED TO BE HOST ANATOMY WAS OBSERVED SURROUNDING THE RETURNED VALVE AND ANTERIOR MITRAL LEAFLET COVERING ENTIRE VALVE INFLOW ASPECT. WHAT APPEARED TO BE ANTERIOR MITRAL LEAFLET WITH MITRAL AORTIC CURTAIN AND CHORDAE WAS ATTACHED TO ONE SIDE OF THE VALVE WITH THE AORTIC ROOT AND SURROUNDING HOST TISSUE / OVERGROWTH. ANTERIOR MITRAL LEAFLET COVERING WAS LIFTED DURING EVALUATION FOR VISUAL OBSERVATIONS OF THE INFLOW ASPECT. LEAFLET 3 HAD AN APPROXIMATELY 6MM LONG TEAR NEAR COMMISSURE 1 AND AN APPROXIMATELY 7MM LONG TEAR NEAR COMMISSURE 3. LEAFLET 2 HAD AN APPROXIMATELY 3MM LONG TEAR NEAR COMMISSURE 2. TORN EDGES APPEARED TO BE MATCHED UP. THICKEN AND SWOLLEN TISSUE WERE VISIBLE ON THE FREE MARGINS AT THE COMMISSURES AND THE TEARS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 5MM ON LEAFLET 1 ON THE OUTFLOW ASPECT. MODERATE HOST TISSUE OVERGROWTH WAS ALSO OBSERVED ON THE SURROUNDING HOST ANATOMY. HOST TISSUE OVERGROWTH WAS MINIMAL TO MODERATE AT THE OUTFLOW STENT CIRCUMFERENCE. WHAT APPEARED TO BE BLOOD RESIDUE WERE VISIBLE ON BOTH INFLOW AND OUTFLOW ASPECTS. X-RAY DEMONSTRATED WIREFORM INTACT. MULTIPLE SUTURES REMAINED ATTACHED TO THE SEWING RING. H11: ADDITIONAL MANUFACTURER NARRATIVE: THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO RELATED MANUFACTURING NONCONFORMANCES WERE IDENTIFIED. STRUCTURAL VALVE DEGENERATION (SVD) IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BIOPROSTHETIC HEART VALVE (BHV) IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. SVD IS AN ACQUIRED CONDITION, INTRINSIC TO BIOPROSTHETIC VALVES, CHARACTERIZED BY DETERIORATION OF THE LEAFLETS OR SUPPORTING STRUCTURES, LEADING TO THICKENING, CALCIFICATION, TEARING, OR DISRUPTION OF THE PROSTHETIC VALVE MATERIALS. THESE CHANGES RESULT IN VALVULAR DYSFUNCTION MANIFESTING AS STENOSIS AND/OR REGURGITATION WITH A CONSEQUENT DROP IN HEMODYNAMIC EFFICACY OF THE VALVE. DESPITE THE ADVANCEMENTS IN THE HEART VALVE INDUSTRY, SVD COMMONLY BEGINS 7- 8 YEARS AFTER IMPLANTATION, WITH A CONSIDERABLY INCREASED RATE IN PATIENTS WITH PERTINENT COMORBIDITIES AND/OR AN IMPLANT DURATION OF GREATER THAN 10 YEARS. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. 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. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS, INCLUDING AN IMPLANT DURATION OF NEARLY 10 YEARS AND PATIENT COMORBIDITIES LIKE CHRONIC KIDNEY DISEASE (CKD) LIKELY CONTRIBUTED TO LEAFLET THICKENING, PANNUS FORMATION, AND LEAFLET TEARING. THESE FINDINGS ARE CONSISTENT WITH EXPECTED WEAR AND TEAR OVER TIME AND ALIGN WITH POSTMORTEM OBSERVATIONS OF LEAFLET DETACHMENT, REGURGITATION, AND VALVULAR DYSFUNCTION, CONSISTENT WITH STRUCTURAL VALVE DETERIORATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS IDENTIFIED.
THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. THE PRODUCT WAS RETURNED FOR EVALUATION. CUSTOMER REPORT ISSUE WITH LEAFLET WAS CONFIRMED DUE TO LEAFLET TEAR. REPORT OF REGURGITATION WAS UNABLE TO BE CONFIRMED DURING VISUAL OBSERVATION. AS RECEIVED, WHAT APPEARED TO BE HOST ANATOMY/CONDUIT WAS OBSERVED SURROUNDING THE RETURNED VALVE AND HOST TISSUE/OVERGROWTH COVERING ENTIRE VALVE INFLOW ASPECT. OVERGROWTH WAS ATTACHED TO ONE SIDE OF THE VALVE. HOST TISSUE/OVERGROWTH COVERING WAS LIFTED DURING EVALUATION FOR VISUAL OBSERVATIONS OF THE INFLOW ASPECT. LEAFLET 3 HAD AN APPROXIMATELY 6MM LONG TEAR NEAR COMMISSURE 1 AND AN APPROXIMATELY 7MM LONG TEAR NEAR COMMISSURE 3. LEAFLET 2 HAD AN APPROXIMATELY 3MM LONG TEAR NEAR COMMISSURE 2. TORN EDGES APPEARED TO MATCHED UP. THICKEN AND SWOLLEN TISSUE WERE VISIBLE ON THE FREE MARGINS AT THE COMMISSURES AND THE TEARS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 5MM ON LEAFLET 1 ON THE OUTFLOW ASPECT. MODERATE HOST TISSUE OVERGROWTH WAS ALSO OBSERVED ON THE SURROUNDING HOST ANATOMY. HOST TISSUE OVERGROWTH WAS MINIMAL TO MODERATE AT THE OUTFLOW STENT CIRCUMFERENCE. WHAT APPEARED TO BE BLOOD RESIDUE WERE VISIBLE ON BOTH INFLOW AND OUTFLOW ASPECTS. X-RAY DEMONSTRATED WIREFORM INTACT. MULTIPLE SUTURES REMAINED ATTACHED TO THE SEWING RING. 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.
EDWARDS RECEIVED NOTIFICATION FROM UNITED KINGDOM THAT A VALVE MODEL 290027MM, WHICH HAD BEEN IMPLANTED IN THE AORTIC POSITION FOR NINE (9) YEARS AND ELEVEN (11) MONTHS, WAS ABNORMAL IN THAT THE LEAFLET OF THE CUSP AT THE SITE OF THE LEFT CORONARY ARTERY HAD BECOME DETACHED DISTALLY CAUSING ACUTE AORTIC REGURGITATION, LEFT VENTRICULAR FAILURE, AND CLINICAL DETERIORATION LEADING TO DEATH. THE INDEX PROCEDURE INCLUDED AN AORTIC ROOT REPAIR. THE STRUCTURAL LEAFLET ISSUE WAS DISCOVERED DURING POST-MORTEM EXAMINATION AND CAUSE OF DEATH WAS REPORTED AS TERMINAL AORTIC REGURGITATION AND LEFT VENTRICULAR FAILURE. THE PATIENT, WHO INITIALLY RECOVERED WELL AFTER VALVE REPLACEMENT, STARTED DEVELOPING PROGRESSIVE HEART FAILURE APPROXIMATELY TWO YEARS PRIOR TO HIS DEATH, WITH MULTIPLE ADMISSIONS FOR DECOMPENSATED HEART FAILURE, PULMONARY OEDEMA, AND FLUID OVERLOAD. DESPITE MEDICAL THERAPY, LEFT-VENTRICULAR FUNCTION DECLINED FROM 55% TO 22% WITH VALVE OBSTRUCTION, REGURGITATION AND SYMPTOMS INCLUDING DYSPNEA, FATIGUE AND TACHYPNEA. DURING ULTIMATE HOSPITAL ADMISSION, AN ADVANCED HEALTH CARE DIRECTIVE WAS COMPLETED, DOCUMENTING AWARENESS OF HIS SEVERE HEART FAILURE AND AGREEMENT WITH SYMPTOM-DIRECTED CARE WITHOUT ESCALATION TO INTENSIVE CARE NOR CARDIO-PULMONARY RESUSCITATION. PER PATHOLOGIST REPORT, THE FAILURE OF THE AORTIC VALVE IS RESPONSIBLE FOR THIS PATIENT'S RAPID TERMINAL DECLINE AND DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1702461 | SEE H11 | REPLACEMENT HEART-VALVE | DYE | EDWARDS LIFESCIENCES | 2900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Hospitalization| D |