BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 5430820 · Received February 11, 2016

    Report

    Report Number
    2015691-2016-00393
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    December 9, 2015
    Report Date
    January 18, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS, MODEL# 3300TFX, PMA# P860057/S042. ADDITIONAL MANUFACTURER NARRATIVE: CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES AND MANY FACTORS CONTRIBUTE TO ITS ONSET AND PROPAGATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. IN THIS CASE, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESIS FROM CALCIFYING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, MINIMAL TO HEAVY HOST TISSUE WAS OBSERVED AT THE ORIFICE OF LEAFLET 2, THE STENT CIRCUMFERENCE, AND IN THE INFLOW AND OUTFLOW ASPECTS. LEAFLET 1 HAD A HOLE ON THE CUSP REGION, WHICH APPEARED TO BE BEVELED AT THE INFLOW ASPECT. EXTRINSIC CALCIFICATION ON LEAFLET 2 WAS IN CLOSE PROXIMITY TO THE HOLE ON LEAFLET 1. ADDITIONALLY, FOUR (4) COR KNOTS REMAINED ATTACHED TO THE SEWING RING, ONE OF WHICH WAS NEAR LEAFLET 1 AND ALSO IN CLOSE PROXIMITY TO THE HOLE. IT IS UNABLE TO BE CONFIRMED IF EXTRINSIC CALCIFICATION OR THE COR KNOT CAUSED THE HOLE ON LEAFLET 1. LEAFLET 2 HAD AN INDENTATION ON THE INFLOW ASPECT. EXTRINSIC CALCIFICATION ON LEAFLET 3 CAME IN CONTACT WITH THE INDENTATION WHEN THE LEAFLETS WERE IN THE CLOSED POSITION. SERRATED MARKINGS WERE OBSERVED ON LEAFLET 1 NEAR COMMISSURES 1 AND 2. THE SEWING RING WAS CUT AROUND THE VALVE, AND THE WIREFORM WAS EXPOSED ON THE SIDE OF THE VALVE NEAR LEAFLET 1. THE X-RAY DEMONSTRATED AN INTACT WIREFORM, MODERATE TO HEAVY CALCIFICATION ON TWO (2) LEAFLETS, AND A BENT COMMISSURE. THE FRAME APPEARED TO BE EXPANDED ASYMMETRICALLY AND CANTED. (B)(4). THE CLINICAL REPORT OF AORTIC STENOSIS, CALCIFICATION, AND PANNUS WERE CONFIRMED; HOWEVER, THE CLINICAL REPORT OF REGURGITATION COULD NOT BE CONFIRMED THROUGH VISUAL OBSERVATIONS. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH THAT TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE BUT ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ADDITIONALLY, MANY FACTORS CAN CONTRIBUTE TO CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON CALCIFICATION AND PANNUS IN BIOPROSTHETIC HEART VALVES, THE CAUSES ARE THESE MECHANISMS ARE STILL NOT FULLY UNDERSTOOD AND THE ROOT CAUSE FOR THE HOST TISSUE GROWTH AND CALCIFICATION CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS 23MM BIOPROSTHETIC AORTIC HEART VALVE IS EXHIBITING SEVERE STENOSIS AFTER AN IMPLANT DURATION OF ONE (1) YEAR, SIX (6) MONTHS. A 2D ECHOCARDIOGRAM WAS PERFORMED IN WHICH THE PROSTHETIC VALVE LEAFLETS APPEARED CALCIFIED (PEAK GRADIENT = 43 MMHG, MEAN GRADIENT = 24 MMHG) AND THERE WAS MILD AORTIC REGURGITATION; THE VALVE APPEARED TO BE STABLE IN ITS ATTACHMENT TO THE AORTIC ANNULUS. RE-INTERVENTION IS PLANNED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED ADDITIONAL INFORMATION THAT THIS PROSTHETIC HEART VALVE WAS EXPLANTED ONE (1) YEAR, EIGHT (8) MONTHS DUE TO STRUCTURAL VALVE DETERIORATION, STENOSIS, MILD REGURGITATION, AND CALCIFICATION. AS REPORTED, THE PATIENT WAS HAVING PROGRESSIVE SHORTNESS OF BREATH WITH CONGESTIVE HEART FAILURE. HE WAS TAKEN TO SURGERY WHERE THE INTRA-OP TEE DEMONSTRATED LITTLE TO NO MOVEMENT OF ALL THREE (3) PERICARDIAL VALVE LEAFLETS WITH SUBVALVULAR DEBRIS, WHICH APPEARED TO BE CALCIUM. UPON VISUALIZATION, THE VALVE DEMONSTRATED CALCIUM UNDERNEATH THE LEAFLETS WITH THICKENING OF ALL THREE (3) LEAFLETS WITH FIBROSIS. THE SURGEON INDICATED THIS EARLY STRUCTURAL VALVE DETERIORATION WOULD HAVE OCCURRED WITH ANY BIOPROSTHETIC VALVE DUE TO THE PATIENT'S CALCIUM METABOLISM AND/OR PHARMACOLOGIC SUPPORT NEEDED TO TREAT THE PULMONARY HYPERTENSION AND BEING ON STEROID MEDICATION FOR 40 YEARS. THE VALVE WAS EXCISED, AN AORTIC ROOT ENLARGEMENT AND RECONSTRUCTION OF THE NONCORONARY SINUS OF VALSALVA WITH DACRON WAS COMPLETED, AND 23MM MECHANICAL VALVE WAS IMPLANTED. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS LATER DISCHARGED ON POST-OP DAY SIX (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87751 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ASPIRIN