BEUDAMED
    FDA Adverse Event Death Summary report: N

    SI BRITE TIP

    MDR report key: 1021151 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00810
    Event Type
    Death
    Date Received
    March 28, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR DAYS FOLLOWING THE PROCEDURE, THE PT WAS DIAGNOSED WITH MASSIVE RETROPERITONEAL BLEEDING AND SHOCK AND WAS TAKEN TO THE OPERATING ROOM (OR) FOR REPAIR OF AN AV FISTULA AND CONTROL BLEEDING FROM THE RIGHT ILIAC ARTERY AND ILIAC VEIN. WHEN THE PT WAS RECEIVED IN THE OR, THE ABDOMEN HAD ALREADY BEEN OPENED. EVERYTHING THAT WAS IN THE RIGHT SIDE OF THE RETROPERITONEUM WAS INSPECTED AND A LARGE AMOUNT OF BLOOD WAS REMOVED, ABOUT 2000ML, AND AT THAT TIME, IT WAS NOTICED THAT THERE WAS ACTIVE BLEEDING IN THE AREA AROUND THE ARTERY AND THE VEIN. THERE WAS ACTIVE BLEEDING DOWN CLOSE TO THE INGUINAL CANAL. WITH A CAREFUL DISSECTION, THE PHYSICIAN WAS TO IDENTIFY THE COMMON ILIAC ARTERY AS WELL AS THE EXTERNAL AND THE HYPOGASTRIC. THE PHYSICIAN WAS ALSO ABLE TO DISSECT AND INVESTIGATE THE ILIAC VEIN. BOTH WERE BLEEDING QUITE BRISKLY, SO THE PHYSICIAN CROSSED CLAMPED THE EXTERNAL ILIAC ARTERY. THERE WAS STILL BLEEDING, SO THE PHYSICIAN DISSECTED DOWN TO THE INGUINAL LIGAMENT AND WAS ABLE TO IDENTIFY THE ILIAC ARTERY AND THE ILIAC VEIN WHERE THEY WERE INTIMATELY ATTACHED WITH A LOT OF REACTION IN THE AREA. THE AREA WAS CAREFULLY DISSECTED AND A LARGE COLLECTION WAS FOUND BETWEEN THE EXTERNAL ILIAC ARTERY AND THE ILIAC VEIN THAT WAS ACTIVELY BLEEDING. THE OPENING IN THE ARTERY WAS REPAIRED WITH INTERRUPTED STITCHES OF 5-0 PROLENE. THE CLAMPS WERE REMOVED AND NO MORE BLEEDING WAS SEEN. THE SAME WAS DONE WITH THE ILIAC VEIN, WHICH WAS REPAIRED WITH 6-0 PROLENE. THE SITE WAS IRRIGATED AND INSPECTED FOR MORE BLEEDING. NONE WAS FOUND. THERE WAS NO MORE THRILL FELT IN THE ILIAC VEIN. THE SMALL INCISION IN THE GROIN WAS STITCHED CLOSED. THE PT TOLERATED THE PROCEDURE WELL AND LEFT THE OR IN EXTREMELY CRITICAL CONDITION AND TAKEN DIRECTLY TO THE ICU. IT WAS REPORTED THAT IN 2008, THE PT EXPIRED. THE CAUSE OF DEATH WAS CARDIAC ARREST. THE EVENT WAS EVALUATED AND WAS DETERMINED TO BE UNRELATED TO THE CORDIS PRODUCT BUT RELATED TO THE INDEX PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT# 9616099-2008-00810 AND 9616099-2008-00811.

    Description of Event or Problem · 1

    FOUR DAYS FOLLOWING A CAROTID STENTING PROCEDURE, THE PT COLLAPSED AND ARRESTED. SHE HAD BEEN DOING WELL AND WAS SCHEDULED FOR OPEN REPAIR OF A LEFT CAROTID STENOSIS. SHE WAS RESUSCITATED AND INTUBATED. HER HEMOGLOBIN WAS FOUND TO BE 7. THE PT'S ABDOMEN BECAME MORE AND MORE DISTENDED. IT WAS FELT THAT THERE WAS EVIDENCE OF INTRAPERITONEAL BLEEDING OF THE RIGHT SIDE. THE PT IS A FEMALE, WHO WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED THE SAME DAY, AND PT WAS ASYMPTOMATIC. THE TARGET LESION LOCATION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. THERE WAS AN OCCLUSION IN THE CONTRALATERAL CAROTID. THE PHYSICIAN ACCESSED THE PT THROUGH THE RIGHT FEMORAL ARTERY WITH A 4FR BRITE TIP SHEATH. A 4FR. PIGTAIL CATHETER WAS INSERTED AND AN ARCH ANGIOGRAM WAS PERFORMED. THE PIGTAIL WAS REMOVED AND A 4FR BERENSTEIN SELECTIVE CATHETER WAS INSERTED FOR SELECTIVE VIEWS OF THE LEFT AND RIGHT CAROTID ARTERIES. THE BERENSTEIN CATHETER WAS REMOVED AND THE 4FR SHEATH WAS REMOVED AND REPLACED WITH AN 8FR 11CM BRITE TIP SHEATH. ADD'L SELECTIVE ANGIOGRAMS WERE OBTAINED OF THE RIGHT CAROTID ARTERY. AN ANGIOGUARD RX DISTAL PROTECTION DEVICE WAS INSERTED INTO THE RIGHT CAROTID BEYOND THE LESION AND A 4 X 20 AVIATOR BALLOON WAS INSERTED FOR PRE-DILATION (7ATM 12 SEC). AN 8 X 40MM PRECISE STENT WAS INSERTED INTO THE LESION IN THE RIGHT CAROTID AND DEPLOYED. A 5 X 20 MM AVIATOR BALLOON WAS INSERTED FOR POST-DILATION. THE BALLOON WAS REMOVED. FINAL ANGIOGRAMS WERE PERFORMED AND THE ANGIOGUARD WAS REMOVED. THE PROCEDURE WAS COMPLETED. ARTERIAL PRESSURE WAS HELD FOR 50 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R ANGIOGUARD DISTAL PROTECTION DEVICE| PRECISE STENT| 4X20 AVIATOR BALLOON