BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3203335 · Received July 2, 2013

    Report

    Report Number
    2015691-2013-20517
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: X-RAY. DEVICE EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED; LEAFLET 1 HAD A CUT AREA, APPROX 8MM X 8MM, LEAFLET 2 HAD A CUT AREA APPROX 8MM X 6MM, AND LEAFLET 3 HAD A CUT AREA APPROX 8MM X 7MM. THE CUT SECTIONS WERE NOT RETURNED WITH THE VALVE, AND APPEAR TO BE A RESULT OF HOSPITAL PATHOLOGY TESTING/SAMPLING. LEAFLET 2 ALSO HAD A CUT NEAR COMMISSURE 2, APPROX 5MM IN LENGTH. NO VISIBLE CALCIFICATION WAS OBSERVED ON THE TISSUE WHICH REMAINS ATTACHED TO THE VALVE. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 3MM. HOST TISSUE WAS HEAVY AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. ADDITIONAL MANUFACTURER NARRATIVE: PER THE CONDITION OF THE RETURNED VALVE (CUT LEAFLETS), THE REPORTED EVENT CANNOT BE CONFIRMED OR FURTHER EVALUATED. HOWEVER, AS PREVIOUSLY NOTED, THE OPERATIVE REPORT INDICATES, " A TRANSVERSE AORTOTOMY WAS CREATED JUST ABOVE THE PREVIOUS AORTOTOMY REVEALING A PERFORATION OF THE LEAFLET WHICH FACED THE RIGHT CORONARY OSTIUM. I NOTICED THAT THE SUTURES HOLDING THE VALVE IN PLACE WERE SLIGHTLY ELONGATED, BUT NOTHING DRAMATIC. CLEARLY THIS PERFORATION HAD COME FROM RUBBING AGAINST THE SUTURE MATERIAL. THERE WAS ANOTHER SCRAPE MARK ON THE VALVE THAT WAS NEARLY PERFORATED". THEREFORE, THE PROVIDED INFORMATION SUGGESTS IT IS LIKELY THAT THIS EVENT WAS CAUSED BY SUTURE TAIL ABRASION. SUTURE TAIL ABRASION CAN OCCUR DUE TO LOOSE EXPOSED SUTURE TAILS COMING INTO CONTACT WITH THE VALVE LEAFLET THUS CAUSING A PERFORATION. PRODUCT LABELING INSTRUCTS THE USER ON HOW TO AVOID SUTURE TAIL ABRASIONS AS FOLLOWS: ¿WHEN USING INTERRUPTED SUTURES, IT IS IMPORTANT TO CUT THE SUTURES CLOSE TO THE KNOTS AND TO ENSURE THAT EXPOSED SUTURE TAILS WILL NOT COME INTO CONTACT WITH THE LEAFLET TISSUE. CASES HAVE BEEN REPORTED IN WHICH BIOPROSTHESES DEVELOPED SEVERE REGURGITATION AND HAD TO BE REPLACED AS A RESULT OF WEAR DUE TO CONTACT WITH SUTURES.¿ THE REPORTED INFORMATION AND EDWARDS INVESTIGATION SUGGESTS NO DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT THIS EVENT IS RELATED TO PROCEDURAL/TECHNICAL FACTORS. NO FURTHER ACTION IS REQUIRED AT THE TIME, EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RECEIVED BY EDWARDS; HOWEVER, EVALUATION HAS NOT YET BEEN COMPLETED. DEVICE EVALUATION WILL BE REPORTED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN EDWARDS 2700TFX-21MM BIOPROSTHETIC AORTIC VALVE WAS EXPLANTED AFTER A PERIOD OF APPROXIMATELY 3.5 YEARS DUE TO A TORN LEAFLET FROM A POSSIBLE SUTURE TAIL. PATIENT IS REPORTED AS STABLE FOLLOWING THE PROCEDURE. OPERATIVE REPORT INDICATES: "A TRANSVERSE AORTOTOMY WAS CREATED JUST ABOVE THE PREVIOUS AORTOTOMY REVEALING A PERFORATION OF THE LEAFLET WHICH FACED THE RIGHT CORONARY OSTIUM. I NOTICED THAT THE SUTURES HOLDING THE VALVE IN PLACE WERE SLIGHTLY ELONGATED, BUT NOTHING DRAMATIC. CLEARLY THIS PERFORATION HAD COME FROM RUBBING AGAINST THE SUTURE MATERIAL. THERE WAS ANOTHER SCRAPE MARK ON THE VALVE THAT WAS NEARLY PERFORATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303024 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700TFX R-09H1791

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R