BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2874482 · Received December 14, 2012

    Report

    Report Number
    2015691-2012-18859
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: X-RAY. EVALUATION SUMMARY: AS RECEIVED, LEAFLET 1 HAD A CUT AREA OF 4MMX10MM, LEAFLET 2 HAD A CUT AREA OF 3MMX11MM AND LEAFLET 3 HAD A CUT AREA OF 3MMX10MM. SEWING RING WAS ALSO CUT NEAR COMMISSURE 2. CUT SECTIONS WERE NOT RETURNED WITH THE VALVE. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. THE RETURNED VALVE WAS MEASURED AND CONFIRMED TO BE A 23MM VALVE, AS LABELED. NO OTHER INCONSISTENCIES PROVIDED. THIS SUBJECT DEVICE IS SUPPLIED WITH MODEL 1130 SIZER. AS INDICATED ON THE PRODUCT INFORMATION FOR USE (IFU), "MODEL 1130 ARE FABRICATED FROM (B)(4) TO PERMIT DIRECT OBSERVATION OF THEIR FIT WITHIN THE ANNULUS. THE MODEL 1130 SIZER WAS DEVELOPED TO FACILITATE ACCURATE SIZING OF THE CARPENTIER-EDWARDS PERIMOUNT MAGNA MODEL 3000TFX VALVE IN A WIDE RANGE OF PATIENTS. EACH SIZER CONSISTS OF A HANDLE WITH A DIFFERENT SIZER CONFIGURATION AT EACH END. ON ONE SIDE OF THE HANDLE IS A CYLINDRICAL END WITH AN INTEGRATED LIP THAT REFLECTS THE VALVE SEWING RING GEOMETRY. ON THE OTHER SIDE OF THE HANDLE IS A VALVE REPLICA END THAT REFLECTS THE VALVE SEWING RING GEOMETRY AS WELL AS THE HEIGHT AND LOCATION OF THE STENT POSTS." THE PRODUCT IFU PROVIDES FURTHER INSTRUCTIONS AND PRECAUTIONS FOR PROPER SIZING AND IMPLANTATION OF THIS DEVICE. PARTIAL OR TOTAL OCCLUSION OF THE CORONARY OSTIA IS A RECOGNIZED COMPLICATION OF AN AORTIC VALVE REPLACEMENT. IT IS TYPICALLY THE RESULT OF A TECHNICAL ERROR DURING VALVE IMPLANT AND NOT RELATED TO A PRODUCT MALFUNCTION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SALES THAT AN EDWARDS MODEL 3000TFX 23 MM WAS EXPLANTED AT IMPLANT, AND REPLACED WITH SAME MODEL, SIZE 21 MM DEVICE. VIA FOLLOW UP, THE SURGEON INDICATED THE FOLLOWING: " IN SHORT, THIS WAS A (B)(6), F, LARGE BODY HABITUS (BSA 2.1-2.2) WITH A BICUSPID AORTIC VALVE AND SMALL ROOT. MAGNA SIZING GAVE US A 23 MM VALVE, WHICH WAS SNUG, BUT APPEARED TO SEAT PROPERLY. IN FACT THE VALVE WAS SEATED WELL, BUT WAS OBSTRUCTING BOTH CORONARY OSTIA. I NEEDED TO RE-ARREST THE HEART AFTER APPROXIMATELY 45 MINUTES OF TRYING TO FIGURE WHAT WAS WRONG WITH BOTH VENTRICLES, AND UPON RE-EXAMINING THE VALVE, COULD NOT LOCATE EITHER CORONARY OSTIA (EXTREMELY LIMITED SPACE WITHIN TUBULAR SHAPED ROOT). I DOWNSIZED TO A 21 MM VALVE, WHICH SEATED OK, BUT AFFORDS HER AN EOAI OF JUST ABOVE 0.9. THE PATIENT IS MAKING A SLOW RECOVERY, THOUGH INCIDENTALLY, SHE ALSO HAS A MODERATE SIZED PERIVALVULAR LEAK, WHICH I QUESTIONED IS A RESULT OF A DOWNSIZED VALVE." THE OPERATIVE REPORT INDICATES, " [23 MM VALVE WAS IMPLANTED], THE PATIENT WAS PLACED IN TRENDELENBURG POSITION, DE-AIRING MANEUVERS WERE PERFORMED, AND THE AORTIC CROSS-CLAMP WAS REMOVED. HOWEVER, BOTH VENTRICLES REMAINED NEARLY AKINETIC. A RIGHT VENTRICULAR PACING WIRE WAS PLACED ON THE RIGHT VENTRICLE, BUT THERE WAS NO SIGNIFICANT MYOCARDIAL CONTRACTILITY. THE PATIENT WAS RESTED ON FULL-FLOW CARDIOPULMONARY BYPASS WITH INTERMITTENT ASSESSMENTS OF NATIVE CONTRACTILITY. WE SUSPECTED EITHER INTRACORONARY AIR OR INADEQUATE MYOCARDIAL PROTECTION DURING THE PROCEDURE THAT MIGHT HAVE ACCOUNTED FOR HER POOR CARDIAC FUNCTION, BUT NEITHER OF THESE INSTANCES WOULD'VE NECESSARILY BEEN AS SUSTAINED OR AS PROFOUND AS THIS. OUR CONCERN WAS THAT THE VALVE PROSTHESIS ITSELF MIGHT'VE BEEN OBSTRUCTING THE CORONARY OSTIA AND THEREFORE, BLOOD FLOW TO THE MYOCARDIUM. THE ASCENDING AORTA WAS AGAIN CROSS-CLAMPED. ANTEGRADE COLD BLOOD POTASSIUM CARDIOPLEGIA WAS USED TO ACHIEVE A DIASTOLIC ARREST. A REPEAT TRANSVERSE AORTOTOMY WAS USED TO EXPOSE THE PREVIOUSLY PLACED BIOPROSTHETIC AORTIC VALVE. AS SUSPECTED, WE ATTEMPTED TO IDENTIFY BOTH THE RIGHT AND LEFT CORONARY ARTERIES, AND THEY COULD NOT BE LOCATED. THEY WERE LIKELY OBSTRUCTED BY THE STENT OF THE PROSTHETIC VALVE. THE PROSTHETIC VALVE WAS THEREFORE REMOVED, ALONG WITH ITS ASSOCIATED SUTURES AND PLEDGETS. A TOTAL OF THIRTEEN, 2-0 ETHIBOND PLEDGETED SUTURES WERE AGAIN PLACED ON THE VENTRICULAR SIDE AND BROUGHT SEQUENTIALLY THROUGH A SMALLER, 21-MM BIOPROSTHETIC AORTIC VALVE. SUTURES WERE TIED DOWN SEQUENTIALLY. THERE WERE NO PERIVALVULAR LEAKS. BOTH CORONARY OSTIA WERE STILL VISUALIZED. THE AORTOTOMY WAS CLOSED WITH 4-0 PROLENE SUTURE IN 2 LAYERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R