BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3082085 · Received April 29, 2013

    Report

    Report Number
    9616099-2013-00256
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF HOURS AFTER USE OF EXOSEAL DEVICE FOR VASCULAR CLOSURE, A (B)(6) PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA RESULTING IN CARDIAC ARREST AND DEATH. A LARGE HEMATOMA WAS NOTED AT THE PUNCTURE SITE AT THIS TIME. THE AUTOPSY REPORT WAS NOT AVAILABLE FOR REVIEW. INITIALLY, THE PATIENT UNDERWENT A PCI OF UNKNOWN VESSELS TWO WEEKS PRIOR USING OPPOSITE FEMORAL APPROACH. AFTER THIS PROCEDURE, MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS, BUT HEMATOMA OCCURRED. PRESCRIBED MEDICAL REGIME AFTER THE PROCEDURE INCLUDED CLOPIDOGREL SULFATE 75 MG/DAY AND ASPIRIN 100 MG/DAY. THERE WAS NO INFORMATION REGARDING THIS INITIAL PROCEDURE PROVIDED. IT IS REPORTED THAT THE PATIENT WAS ADMITTED TO UNDERGO PCI OF THE AHA11~13 CORONARY VESSELS TWO WEEKS AFTER THE FIRST PROCEDURE. DURING THE REPORTED PROCEDURE, APPROACH WAS MADE FROM THE COMMON FEMORAL ARTERY WITH A SHEATH INTRODUCER (TERUMO¿S 6F 25 CM). IT WAS RETROGRADE APPROACH. THERE WAS NO INFORMATION AVAILABLE REGARDING ACCESS SITE. A GUIDING CATHETER WAS ENGAGED TO THE LEFT MAIN TRUCK (LMT) AND THE LESION WAS CROSSED WITH A GUIDEWIRE (NEO¿S SOFT). THEN OCT (OPTICAL COHERENCE TOMOGRAPHY) WAS CONDUCTED AND THERE WAS MUCH OF PLAQUE WAS AT THE LESION AND RUPTURE OF PLAQUE WAS ALSO OBSERVED. IT IS UNKNOWN IF THROMBUS WAS PRESENT. PRE-DILATATION WITH A BALLOON (TREK 3.0/15 MM) WAS CONDUCTED AND A STENT (XIENCE PRIME 3.0/23 MM) WAS IMPLANTED AT THE LESION WITH DISTAL PROTECTION DEVICE (FILTRAP 5.0 MM). OCT WAS CONDUCTED AGAIN AND SUFFICIENT STENTS APPOSITION WAS OBSERVED. HEPARIN 7000 IU WAS ADMINISTERED DURING THE PCI PROCEDURE. ACT LEVEL WAS UNKNOWN. AFTER THE PCI, THE SHEATH INTRODUCER WAS EXCHANGED FOR A SHEATH INTRODUCER (BRITE TIP SHEATH INTRODUCER 6F 11 CM), AND THE EXOSEAL (6F: COMPLAINT PRODUCT) WAS USED FOR HEMOSTASIS. THE EXOSEAL DEPLOYMENT PLUG WAS FULLY DEPRESS AND FLUSHED AGAINST THE HANDLE WITH NO DIFFICULTY. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE REMOVED AS A SINGLE UNIT FROM THE PATIENT APPROXIMATELY 1-2 SECONDS AFTER DEPRESSING THE DEPLOYMENT BUTTON. MANUAL COMPRESSION WAS CONDUCTED FOR 5 MINUTES AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. A COMPRESSION BANDAGE WAS APPLIED TO THE PUNCTURE SITE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WHERE APPROXIMATELY ONE AND A HALF HOURS AFTER EXOSEAL WAS IMPLANTED THE PATIENT EXPIRED DUE TO CARDIAC ARREST. AT THIS TIME, A LARGE HEMATOMA WAS CONFIRMED AT THE GROIN. THE HEMATOMA WAS REPORTED TO BE 15-20 CM IN DIAMETER AND THE ESTIMATED AMOUNT OF THE BLEEDING REPORTED WAS APPROXIMATELY 500 ML. THE PATIENT¿S MEDICAL HISTORY INCLUDES DEMENTIA, OMI, DIABETES MELLITUS AND RHEUMATOID ARTHRITIS. THE PATIENT¿S WEIGHT WAS (B)(6). IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH THE BED REST PRESCRIBED AFTER DEPLOYMENT DUE TO DEMENTIA AND A FAMILY MEMBER WAS CARING FOR HER. HOWEVER, WHEN THE FAMILY MEMBER LEFT THE RECOVERY ROOM, THE PATIENT ARRESTED. THE HOSPITAL¿S POST-HEMOSTASIS MANAGEMENT PROTOCOL IS UNKNOWN. THE PHYSICIAN COMMENTED THAT ¿THE CAUSE OF HEMATOMA AFTER PLUG PLACEMENT WAS DUE TO THE PATIENT COULD NOT KEEP QUIET DUE TO DEMENTIA¿. A REVIEW OF THE MANUFACTURING RECORDS FOR THE BRITE TIP CSI COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. 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. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. COMPLIANCE WITH DECREASED MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION AFTER THE PROCEDURE CONTRIBUTES TO HEMATOMA FORMATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (INCREASED AGE, MULTI VESSEL HEART DISEASE, NON-COMPLIANCE WITH LIMITED MOBILITY) AND PHARMACEUTICAL FACTORS (ANTIPLATELET THERAPY) MAY HAVE CONTRIBUTED TO THE HEMATOMA REPORTED RESULTING IN CARDIAC ARREST. WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN COMMENTED THE CAUSE OF HEMATOMA AFTER PLUG PLACEMENT WAS DUE TO THE PATIENT COULD NOT KEEP QUIET DUE TO DEMENTIA. THE PUNCTURE SITE STARTED BLEEDING DURING THE PATIENT'S RECOVERY AT THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED ON THE AUTOPSY REPORT, STATES THAT THERE WAS NO THROMBUS IN THE CORONARY ARTERY AND THE IMMEDIATE CAUSE OF CARDIAC ARREST WAS UNKNOWN. THE PHYSICIAN ALSO SAID THAT IT COULD NOT BE DENIED CAUSAL RELATIONSHIP BETWEEN THE HEMATOMA AT THE ACCESS SITE AND THE DEATH. FURTHER INFORMATION WILL BE PROVIDED, IF IT COMES AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 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 #9616099-2013-00257.

    Description of Event or Problem · 1

    APPROXIMATELY 30 MINUTES OF USING AN EXOSEAL VASCULAR CLOSURE DEVICE (VCD), THE PATIENT EXPIRED DUE TO CARDIAC ARREST. THE VCD WAS USED FOR HEMOSTATIS OF THE COMMON FEMORAL ARTERY AFTER A STENTING PROCEDURE. APPROACH WAS MADE FROM THE COMMON FEMORAL ARTERY WITH A SHEATH INTRODUCER (TERUMO'S 6F 25CM). THERE WAS NO INFORMATION AVAILABLE REGARDING ACCESS SITE. IT WAS A RETROGRADE APPROACH. A GUIDING CATHETER WAS ENGAGED TO THE LMT AND THE LESION WAS CROSSED WITH A GUIDEWIRE (NEO'S SOFT). THEN OCT (OPTICAL COHERENCE TOMOGRAPHY) WAS CONDUCTED AND THERE WAS PLAQUE AT THE LESION AND RUPTURE OF PLAQUE WAS ALSO OBSERVED. THERE WAS NO CALCIFICATION OR STENOSIS AT THE PUNCTURE SITE. PRE-DILATATION WITH A BALLOON (TREK 3.0/15MM) AND A STENT (XIENCE PRIME 3.0/23MM) WAS IMPLANTED AT THE LESION WITH DISTAL PROTECTION DEVICE (FILTRAP 5.0MM). OCT WAS CONDUCTED AGAIN AND SUFFICIENT STENTS APPOSITION WAS OBSERVED. AFTER THE PCI, THE SHEATH INTRODUCER WAS EXCHANGED FOR A 6F BRITE TIP. THE EXOSEAL DEPLOYMENT PLUG WAS FULLY DEPRESS AND FLUSHED AGAINST THE HANDLE WITH NO DIFFICULTY. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE REMOVED AS A SINGLE UNIT FROM THE PATIENT APPROXIMATELY 1-2 SECONDS AFTER DEPRESSING THE DEPLOYMENT BUTTON. IT WAS REPORTED THAT HEMOSTATIS WAS ACHIEVED WITH THE EXOSEAL, HOWEVER, IT WAS ALSO NOTED THAT AFTER DEPLOYMENT OF THE PLUG, MANUAL COMPRESSION WAS CONDUCTED FOR 5 MINUTES AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITHOUT PROBLEMS. APPROXIMATELY ONE AND A HALF HOUR AFTER THE PROCEDURE (APPROXIMATELY 30 MINUTES AFTER THE PATIENT CAME BACK TO HER ROOM) HER CONDITION SUDDENLY CHANGED TO THE WORSE AND SHE DEVELOPED VT. AT THAT TIME, THERE WAS A BIG HEMATOMA (15-20 CM IN DIAMETER) OBSERVED AT THE ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183851 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15754106

    Patients

    Seq Age Sex Outcome Treatment
    1 Death