BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3180684 · Received June 20, 2013

    Report

    Report Number
    9616099-2013-00382
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ANGIOJET; 7FR X 90CM TERUMO DESTINATION SHEATH; SHEATH WIRE; VIABAHN COVERED STENT. THE PATIENT PRESENTED TO THE CATH LAB WITH A THROMBOSED BRACHIOCEPHALIC ARTERY. PERCUTANEOUS ENTRY VIA THE RIGHT FEMORAL ARTERY APPROACH WAS PERFORMED. MECHANICAL THROMBOLYSIS, PTA, AND STENTING OF THE BRACHIOCEPHALIC, RADIAL, AND ULNAR ARTERIES WERE PERFORMED WITH THE USE OF THE ANGIOJET. HEPARIN, AND TWO-DOSES OF INTEGRILIN WERE ADMINISTERED. THE PATIENT RECEIVED A LOADING DOSE OF PLAVIX AT THE END OF THE PROCEDURE. THE PHYSICIAN ELECTED TO CLOSE THE RIGHT FEMORAL ARTERY (RFA) ENTRY SITE USING A 6 FR EXOSEAL DEVICE AFTER REMOVING THE 7 FR. X 90 CM. NON-CORDIS SHEATH, AND EXCHANGING FOR A 7 FR CORDIS AVANTI SHEATH. APPROPRIATE DEPLOYMENT OF THE EXOSEAL DEVICE WAS OBSERVED. THERE WAS NO REPORTED PROBLEM NOTED WITH THE AVANTI SHEATH. MODERATE MANUAL COMPRESSION WAS PERFORMED FOR SIX (6) MINUTES AFTER EXOSEAL WAS DEPLOYED AND APPARENT HEMOSTASIS WAS SUSPECTED WITH NO GROIN HEMATOMA, OR BLEEDING OBSERVED AT THE FEMORAL ACCESS SITE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00382 AND # 9616099-2013-00383.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT AFTER SUCCESSFUL DEPLOYMENT OF A 6 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IN THE RIGHT FEMORAL ARTERY ACCESS SITE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT AND DEVELOPED BACK PAIN AND HYPOTENSION. A CT SCAN WAS PERFORMED AND A MASSIVE RETROPERITONEAL HEMATOMA WAS DIAGNOSED. THE PATIENT WAS TRANSFERRED TO THE CATH LAB FOR PERCUTANEOUS ACCESS VIA THE LEFT FEMORAL ARTERY. A SHEATH, WIRE, AND CATHETER WERE ADVANCED UP AND OVER THE ILIAC BIFURCATION TO IMAGE THE RIGHT FEMORAL ARTERY TO IDENTIFY THE LOCATION OF THE ARTERIAL BLEED WHICH WAS DETERMINED TO BE AT THE FEMORAL HEAD OF THE LEFT FEMORAL ACCESS PUNCTURE SITE. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS THEN ADVANCED OVER THE BLEEDING SITE AND INFLATED TO ACHIEVE TAMPONADE OF THE BLEED. THEN A VIABAHN COVERED STENT WAS ADVANCED AND DEPLOYED OVER THE BLEEDING SITE EXCLUDING THE BLEED. THE PATIENT RECEIVED FOUR (4) UNITS OF BLOOD, FLUID ADMINISTRATION AND RECOVERED WITHOUT ADDITIONAL COMPLICATIONS. THE PATIENT DID NOT RECEIVE TPA, BUT HAD HEPARIN, AND INTEGRILIN. AT THE COMPLETION OF THE PROCEDURE, A HEPARIN DRIP CONTINUED, PLAVIX LOADING DOSE WAS GIVEN, AND THE ACT WAS BELOW 250 SECONDS. THE PATIENT RECOVERED AND WAS DISCHARGED HOME. INITIALLY, THE PATIENT PRESENTED TO THE CATH LAB WITH A THROMBOSED BRACHIOCEPHALIC ARTERY. THIS PATIENT HAS A LIVER TUMOR, AND UNUSUAL BLOOD CLOTTING FACTORS WHICH WAS SUSPECTED TO BE THE SOURCE OF HER CLOT FORMATION IN THE BRACHIOCEPHALIC ARTERY. PERCUTANEOUS ENTRY VIA THE RIGHT FEMORAL ARTERY APPROACH WAS PERFORMED. MECHANICAL THROMBOLYSIS, PTA, AND STENTING OF THE BRACHIOCEPHALIC, RADIAL, AND ULNAR ARTERIES WERE PERFORMED WITH THE USE OF THE ANGIOJET. HEPARIN, AND TWO-DOSES OF INTEGRILIN WERE ADMINISTERED. THE PATIENT RECEIVED A LOADING DOSE OF PLAVIX AT THE END OF THE PROCEDURE AND HEPARIN DRIP CONTINUED. ACT WAS BELOW 250 SECONDS. THE PHYSICIAN ELECTED TO CLOSE THE RIGHT FEMORAL ARTERY (RFA) ENTRY SITE USING A 6 FR. EXOSEAL DEVICE AFTER REMOVING THE 7 FR. X 90 CM NON-CORDIS SHEATH (TERUMO DESTINATION), AND EXCHANGING FOR A 7 FR. CORDIS AVANTI SHEATH. APPROPRIATE DEPLOYMENT OF THE EXOSEAL DEVICE WAS OBSERVED. THERE WERE NO REPORTED PRODUCT ISSUE WITH THE AVANTI SHEATH. MODERATE MANUAL COMPRESSION WAS PERFORMED FOR SIX (6) MINUTES AFTER EXOSEAL WAS DEPLOYED AND APPARENT HEMOSTASIS WAS SUSPECTED WITH NO GROIN HEMATOMA, OR BLEEDING OBSERVED AT THE FEMORAL ACCESS SITE. THE PATIENT WAS THEN TRANSFERRED TO THE RECOVERY UNIT WHERE SHE DEVELOPED BACK PAIN AND HYPOTENSION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE 7 FR AVANTI SHEATH WAS INCORRECTLY PROVIDED BY STAFF. THE PATIENT HAS RECOVERED AND DISCHARGED HOME. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. (B)(4). A DEVICE HISTORY RECORD REVIEW FOR THE EXOSEAL VCD WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE EXOSEAL IFU LISTS PROLONGED ACCESS SITE-RELATED BLEEDING AS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. ACCESS SITE RETROPERITONEAL BLEEDS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THERE ARE POSSIBLE PROCEDURAL (USE OF 7 FR SHEATH WITH A 6 FR EXOSEAL) AND PHARMACOLOGICAL FACTORS (INTEGRILLIN, HEPARIN, PLAVIX) THAT MAY HAVE CONTRIBUTED TO THE REPORTED RETROPERITONEAL BLEED. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00382 AND # 9616099-2013-00383.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT AFTER SUCCESSFUL DEPLOYMENT OF A 6 FR EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IN THE RIGHT FEMORAL ARTERY ACCESS SITE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT AND DEVELOPED BACK PAIN AND HYPOTENSION. A CT SCAN WAS PERFORMED AND A MASSIVE RETROPERITONEAL HEMATOMA WAS DIAGNOSED. THE PATIENT WAS TRANSFERRED TO THE CATH LAB FOR PERCUTANEOUS ACCESS VIA THE LEFT FEMORAL ARTERY. A SHEATH, WIRE, AND CATHETER WERE ADVANCED UP AND OVER THE ILIAC BIFURCATION TO IMAGE THE RIGHT FEMORAL ARTERY TO IDENTIFY THE LOCATION OF THE ARTERIAL BLEED. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS THEN ADVANCED OVER THE BLEEDING SITE AND INFLATED TO ACHIEVE TAMPONADE OF THE BLEED. THEN A VIABAHN COVERED STENT WAS ADVANCED AND DEPLOYED OVER THE BLEEDING SITE EXCLUDING THE BLEED. THE PATIENT RECEIVED FOUR (4) UNITS OF BLOOD, FLUID ADMINISTRATION AND RECOVERED WITHOUT ADDITIONAL COMPLICATIONS. OF NOTE WAS THAT THIS PATIENT HAS A LIVER TUMOR, AND UNUSUAL BLOOD CLOTTING FACTORS WHICH WAS SUSPECTED TO BE THE SOURCE OF HER CLOT FORMATION IN THE BRACHIOCEPHALIC ARTERY. THE PATIENT DID NOT RECEIVE TPA, BUT HAD HEPARIN, AND INTEGRILIN. AT THE COMPLETION OF THE PROCEDURE, A HEPARIN DRIP CONTINUED, PLAVIX LOADING DOSE WAS GIVEN, AND THE ACT WAS BELOW 250 SECONDS. THE PATIENT RECOVERED AND WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280785 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15723247

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R