BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 4419112 · Received January 14, 2015

    Report

    Report Number
    2017233-2015-00021
    Event Type
    Injury
    Date Received
    January 14, 2015
    Date of Event
    May 3, 2011
    Report Date
    February 20, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORY OF SMOKING, AORTIC VALVE REPLACEMENT IN 1995, DYSPNEA ON EXERTION WHICH BEGAN IN 2010.NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED.THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:LITERATURE CITATION: GONZÁLEZ J, PEÑA DUQUE M, LARRAGA M. EARLY STENOSIS IN A GORE-TEX GRAFT CONNECTED TO THE LEFT MAIN: AN EMERGENCY TRANSRADIAL ANGIOPLASTY FOR A COMPLICATION IN A CABROL PROCEDURE. J INVASIVE CARDOL 2012, 24(10):539-542.

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE IT WAS REPORTED THAT A (B)(6) MALE WITH A HISTORY OF SMOKING AND AORTIC VALVE REPLACEMENT IN 1995, PRESENTED WITH DYSPNEA ON EXERTION WHICH BEGAN IN 2010. IN (B)(6) 2011, THE DYSPNEA PROGRESSED TO APPEAR DURING EVEN LOW LEVELS OF EXERTION. ECHOCARDIOGRAM DETECTED PROSTHETIC AORTIC VALVE STENOSIS WITH AN EJECTION FRACTION OF 50%. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT IN MAY 2011. DURING SURGERY, THE PATIENT HAD AN AORTIC DISSECTION WITH LOSS OF BOTH CORONARY OSTIA AS A COMPLICATION. AORTIC VALVE REPLACEMENT WAS PERFORMED AND A BENTALL AND BONO PROCEDURE WAS IMPLEMENTED TO RECONSTRUCT THE AORTA. THE ORIFICES OF THE CORONARY OSTIA WERE COVERED BY THE AORTIC TUBE AND ADDITIONAL REVASCULARIZATION WAS PERFORMED BY PLACING A SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY AND A 5 MM GORE-TEX® VASCULAR GRAFT TO THE LEFT MAIN (THE CABROL PROCEDURE). AFTER 48 HOURS OF SURGERY, DUE TO PERSISTING HEMODYNAMIC INSTABILITY, THE PATIENT WAS TAKEN TO THE CATH LAB TO CHECK THE STATUS OF BOTH CORONARY GRAFTS. IT WAS STATED THAT AN ANGIOGRAM SHOWED A DIFFUSE STENOSIS OF THE GORE-TEX® VASCULAR GRAFT TO THE LEFT MAIN STARTING AT THE SITE OF THE CORONARY AORTA-ANASTOMOSIS WITH IMPAIRED DISTAL FLOW AROUND THE LEFT CORONARY SYSTEM. AN EMERGENCY PERCUTANEOUS INTERVENTION TO RESCUE THE CABROL GRAFT WAS SUCCESSFULLY PERFORMED. THE PATIENT WAS HEMODYNAMICALLY STABLE AFTER THE PROCEDURE AND WAS EXTUBATED TWO WEEKS POST PROCEDURE. UNFORTUNATELY THE PATIENT EXPIRED 2 MONTHS AFTER THE PROCEDURE DUE TO AN INFECTIOUS LUNG DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32073 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention