EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
Report
- Report Number
- 2015691-2024-07461
- Event Type
- Injury
- Date Received
- September 27, 2024
- Date of Event
- September 3, 2024
- Report Date
- November 21, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11. ADDITIONAL NARRATIVE. UPDATED D4. A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED BECAUSE THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR.
H11. ADDITIONAL NARRATIVE. UPDATED H3 AND H6. H3: PRODUCT EVALUATION. CUSTOMER REPORT OF PANNUS WAS CONFIRMED. STENOSIS, WORSENING GRADIENT, AND REDUCED EXCURSION WERE UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. X-RAY DEMONSTRATED COMMISSURES 1 AND 3 BENT INWARD. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 2MM ON LEAFLET 2 ON THE INFLOW ASPECT AND 1MM ON LEAFLET 2 ON THE OUTFLOW ASPECT. HOST TISSUE ON THE STENT CIRCUMFERENCE WAS MINIMAL AT THE INFLOW ASPECT. SEWING RING HAD A CUT AROUND THE VALVE.
H11. ADDITIONAL NARRATIVE THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INSPIRIS RESILIA AORTIC VALVE, MODEL# 11500A, PMA# P150048. SURGICAL/PERCUTANEOUS INTERVENTION IS INDICATED OR PERFORMED, OR HARM OCCURRED DUE TO THE DEVICE, OR THERE IS A DEVICE MALFUNCTION THAT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THIS EVENT IS CONSIDERED A SERIOUS INJURY. THE DEVICE WAS RETURNED AND PRODUCT EVALUATION IS ONGOING. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.
H11. ADDITIONAL NARRATIVE. UPDATED H6. THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS.
IT WAS REPORTED VIA CLINICAL TRIAL THAT A 11000A 21MM PERICARDIAL AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS VIA A ROSS PROCEDURE DUE TO SEVERE STENOSIS WITH PANNUS AND WORSENING GRADIENTS, SEVERELY REDUCED EXCURSION. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH NYHA CLASS I, AND UNDERWENT ROSS PROCEDURE WITH CORONARY ARTERY REIMPLANTATION, ASCENDING AORTIC REPLACEMENT, AND PULMONIC ROOT REPLACEMENT. INTRAOPERATIVELY, SURGEON NOTED THAT THERE WAS NO CALCIFICATION ON THE 11000A VALVE BUT RATHER WHITE SCAR-LIKE PANNUS CAUSING OBSTRUCTION THAT EXTENDED ONTO THE UNDERSIDE OF THE LEAFLETS INTERFERING WITH THE VALVE FUNCTION. PANNUS WAS DEBRIDED AND SUBAORTIC RING OF PANNUS WAS EXCISED. THE LEAFLETS OF THE EXPLANTED VALVE WERE SOFT AND MOVED NORMALLY FOR OPENING AND CLOSING AFTER THE PANNUS WAS REMOVED. THE PATIENT WAS TRANSPORTED WHILE INTUBATED TO ICU IN CRITICAL CONDITION. ON POD#7 PATIENT RECEIVED A PPM FOR CHB. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POD # 8. PER PATHOLOGY, EXPLANTED VALVE NOTED TO BE TAN-YELLOW, SEMI-CIRCULAR, HARD, BIOMEDICAL DEVICE GROSSLY CONSISTED OF MESH-LIKE WITH RIMS CONTAINING 3 LEAFLETS THAT OPEN EASILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1709375 | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 11000A21MM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention| H| L |