BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SI AVANTI PLUS

    MDR report key: 2240794 · Received September 9, 2011

    Report

    Report Number
    9616099-2011-00713
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD STATES THAT THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) PLUG WAS THOUGHT TO BE DEPLOYED IN THE COMMON FEMORAL ARTERY (CFA). THE PATIENT WENT TO SURGERY WHERE IT WAS DETERMINED THAT THE PLUG WAS DEPLOYED PROPERLY BUT A DISSECTION OCCURRED. ADDITIONAL INFORMATION AND FILM IMAGES RECEIVED CONFIRMED THAT THERE WAS NO VESSEL OCCLUSION. IT WAS NOTED THAT THE PHYSICIAN HAD USED THE EXOSEAL 5-6 TIMES PRIOR TO THIS EVENT. THE PATIENT IS A (B)(6) FEMALE WHO UNDERWENT A DIAGNOSTIC ANGIOGRAM. A CORDIS AVANTI 5.5 FR 11CM SHEATH WAS USED. FEMORAL SUITABILITY WAS VERIFIED UNDER FLUOROSCOPY PRIOR TO USE OF THE EXOSEAL. THE ANGLE OF ACCESS WITH THE SHEATH WAS BETWEEN 30 AND 45 DEGREES. THE VESSEL DIAMETER WAS NOTED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THE ARTERIOTOMY WAS NOT IN OR NEAR AN AREA OF CALCIFIED PLAQUE AND WAS NOT IN OR NEAR A STENTED SEGMENT. THERE WAS NO PRE-EXISTING HEMATOMA NOTED PRIOR TO INSERTING THE EXOSEAL. PRIOR TO USE THE DEVICE WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING OF THE DEVICE AS AN AUDIBLE "CLICK" WAS HEARD. AN ADEQUATE BLEED-BACK SIGNAL WAS OBSERVED. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE VCD. IMMEDIATELY FOLLOWING DEPLOYMENT OF VCD THE PATIENT FELT A LOT OF PAIN AND WAS BROUGHT BACK TO THE PROCEDURE ROOM WHERE A DISSECTION WAS NOTED. IT WAS NOT KNOWN HOW THE DISSECTION WAS TREATED, HOWEVER THE EVENT RESOLVED. ONE CD WITH IMAGES OF FEMORAL ACCESS WAS RECEIVED. IMAGE 15 SHOWS A SHEATH IN THE GROIN. AS CONTRAST WAS INJECTED, LEAKAGE OUT OF THE VESSEL WAS OBSERVED NEAR THE DISTAL TIP OF THE SHEATH, HOWEVER CONTRAST FLOW WAS ALSO OBSERVED FLOWING DISTALLY. NO VESSEL OCCLUSION WAS OBSERVED. THE PHYSICIAN STATED THAT HE LOOKED AT THE IMAGES IN DETAIL AND "THERE IS NO OBSTRUCTION OF FLOW IN THE RIGHT ARTERY, HOWEVER THE EXOSEAL MAY HAVE DEPLOYED SUBINTIMALLY ACCORDING TO VASCULAR SURGERY IN A DISSECTION FLAP". THE PHYSICIAN ADDED "THERE ARE A LOT OF CONFOUNDING FACTORS AS MULTIPLE ATTEMPTS WERE MADE BILATERALLY TO ACCESS THIS VESSEL BY VASCULAR SURGERY AFTER THE EXOSEAL HAD BEEN DEPLOYED". THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THERE ARE POSSIBLE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2011-00713 AND 9616099-2011-00714.

    Additional Manufacturer Narrative · 1

    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 # 9616099-2011-00713 AND 9616099-2011-00714.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD STATES THAT THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) PLUG WAS THOUGHT TO BE DEPLOYED IN THE COMMON FEMORAL ARTERY (CFA). THE PATIENT WENT TO SURGERY WHERE IT WAS DETERMINED THAT THE PLUG WAS DEPLOYED PROPERLY BUT A DISSECTION CAUSED A VESSEL OCCLUSION. THE PATIENT IS A (B)(6) FEMALE WHO UNDERWENT A DIAGNOSTIC ANGIOGRAM. USING AN ANTEGRADE APPROACH A CORDIS AVANTI 5.5 FR 11CM SHEATH WAS INSERTED. FEMORAL SUITABILITY WAS VERIFIED UNDER FLUOROSCOPY PRIOR TO USE OF THE EXOSEAL. THE ANGLE OF ACCESS WITH THE SHEATH WAS BETWEEN 30 AND 45 DEGREES. THE VESSEL DIAMETER WAS NOTED TO BE GREATER THAN OR EQUAL TO 5MM IN DIAMETER. THE ARTERIOTOMY WAS NOT IN OR NEAR AN AREA OF CALCIFIED PLAQUE AND WAS NOT IN OR NEAR A STENTED SEGMENT. THERE WAS NO PRE-EXISTING HEMATOMA NOTED PRIOR TO INSERTING THE EXOSEAL. PRIOR TO USE THE DEVICE WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED AS THE VCD WAS ADVANCED THROUGH THE SHEATH. THE SHEATH LOCKED PROPERLY AGAINST THE COWLING OF THE DEVICE AS AN AUDIBLE "CLICK" WAS HEARD. AN ADEQUATE BLEED-BACK SIGNAL WAS OBSERVED. THE PLUG DEPLOYMENT BUTTON WAS FULLY DEPRESSED AND HEMOSTASIS WAS ACHIEVED SUCCESSFULLY WITH THE VCD. IMMEDIATELY FOLLOWING DEPLOYMENT OF VCD THE PATIENT FELT A LOT OF PAIN. ACCORDING TO THE VASCULAR SURGEON, THE EXOSEAL CAUSED THE DISSECTION AND EVENTUAL OCCLUSION OF THE VESSEL, BUT IT WAS HARD TO TELL HOW SINCE MULTIPLE ACCESS ATTEMPTS OCCURRED IN THE BILATERAL CFA AFTER THE OCCLUSION WAS DISCOVERED BY VASCULAR SURGERY. IT WAS NOTED THAT THE PHYSICIAN HAD USED THE EXOSEAL 5-6 TIMES PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI AVANTI PLUS ENDOVASCULAR VASCULAR ACCESS (DRE) DRE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R EXOSEAL