BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 4110589 · Received September 23, 2014

    Report

    Report Number
    2017233-2014-00494
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 16, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE SHEATH LOT NUMBER WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MEDICATIONS INCLUDE ASPIRIN, COZAAR, DUONEB, OXYGEN, PLAVIX, PANCREASE MT, PANCRELIPASE, ZENPEP, SPIRIVA, PROAIR HFA, AND HAND INHALER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. DUE TO STENOSES AND CALCIFICATION IN THE EXTERNAL ILIAC ARTERIES AND AT THE ILIAC BIFURCATIONS, ANGIOPLASTY WAS REPORTEDLY PERFORMED PRIOR TO INSERTING THE SHEATHS. THE LEFT SIDE 16 FR GORE® DRYSEAL SHEATH STILL MET WITH RESISTANCE DURING ADVANCEMENT, SO ADDITIONAL ANGIOPLASTY WAS PERFORMED. IT WAS REPORTED THERE WAS STILL SOME RESISTANCE ADVANCING THE LEFT SIDE SHEATH, BUT THE SHEATH WAS ABLE TO BE ADVANCED INTO POSITION. AFTER THE SHEATHS WERE IN PLACE, A TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED WITH NO ISSUE. IT WAS REPORTED THERE WAS SOME DIFFICULTY CANNULATING THE CONTRALATERAL GATE OF THE TRUNK DUE TO THE GATE BEING SLIGHTLY CLOSED FROM THE PATIENT¿S ANATOMY AND USER INEXPERIENCE. HOWEVER, THE GATE WAS EVENTUALLY CANNULATED, AND TWO ILIAC EXTENDER COMPONENTS WERE IMPLANTED ON THE RIGHT SIDE WITH NO ISSUE. IT WAS REPORTED THAT WHEN THE LEFT SIDE 16 FR SHEATH WAS PULLED BACK SLIGHTLY FOR REMOVAL, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND IMAGING SHOWED EXTRAVASATION IN THE DISTAL LEFT COMMON ILIAC ARTERY. TWO ADDITIONAL DEVICES WERE IMPLANTED TO COVER THE RUPTURE. THE EXACT CAUSE OF THE RUPTURE IS REPORTEDLY UNKNOWN; HOWEVER, IT WAS REPORTED THE AGGRESSIVE BALLOONING PERFORMED PRIOR TO SHEATH ADVANCEMENT OR ADVANCING THE SHEATH THROUGH THE STENOTIC, CALCIFIED ILIAC ARTERY COULD HAVE CONTRIBUTED TO THE RUPTURE. ONCE THE SHEATHS WERE REMOVED, AN ENDARTERECTOMY WAS REPORTEDLY PERFORMED ON THE LEFT SIDE TO REMOVE CALCIFICATION. IT WAS REPORTED THE PATIENT WAS BROUGHT TO RECOVERY IN STABLE CONDITION, BUT THE PATIENT¿S BLOOD PRESSURE FLUCTUATED POST-OPERATIVELY. THE PATIENT WAS REPORTED TO HAVE SEVERE CORONARY DISEASE AND EXPIRED LATE THE SAME NIGHT OR THE NEXT MORNING. IT WAS REPORTED THE POSSIBLE CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. ADDITIONAL EVENT AND PATIENT INFORMATION HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    ONCE THE SHEATHS WERE REMOVED, AN ENDARTERECTOMY WAS REPORTEDLY PERFORMED ON THE LEFT SIDE TO REMOVE CALCIFICATION. IT WAS REPORTED THE PATIENT WAS BROUGHT TO RECOVERY IN STABLE CONDITION, BUT THE PATIENT'S BLOOD PRESSURE FLUCTUATED POST-OPERATIVELY. THE PATIENT WAS REPORTED TO HAVE SEVERE CORONARY DISEASE AND EXPIRED LATE THE SAME NIGHT. IT WAS REPORTED THE PATIENT EXPIRED FROM CARDIAC ARREST DUE TO A PRE-EXISTING CARDIAC CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589979 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R