BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3852136 · Received June 5, 2014

    Report

    Report Number
    9616099-2014-00367
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    June 1, 2013
    Report Date
    May 13, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARTICLE BY SCHMELTER ET AL ¿SUITABILITY OF EXOSEAL VASCULAR CLOSURE DEVICE FOR ANTEGRADE FEMORAL ARTERY PUNCTURE SITE CLOSURE¿ NOTED THAT AFTER THE USE OF EXOSEAL VASCULAR CLOSURE DEVICE, THERE WERE 14 CASES OF BLEEDING AFTER TWO MINUTES OF MANUAL COMPRESSION, THREE CASES OF PSEUDOANEURYSM THAT WERE TREATED WITH ULTRASOUND GUIDED THROMBIN INJECTION, ONE CASE OF PSEUDOANEURYSM (TREATED WITH MANUAL COMPRESSION) AND HEMATOMA. THERE WAS ONE CASE OF LATE BLEEDING AND HEMATOMA, AND EIGHT CASES OF HEMATOMA. SURGICAL INTERVENTION WAS NOT REQUIRED IN THESE CASES. ALL OF THE CASES OF SIGNIFICANT LATE BLEEDING AND ONE CASE OF PSEUDOANEURYSM WERE TREATED WITH COMPRESSION BANDAGES. THE PATIENTS THAT PRESENTED WITH SIGNIFICANT LATE BLEEDING AFTER THE USE OF THE EXOSEAL SHOWED DERANGEMENTS OF THEIR COAGULATION PARAMETERS BEFORE THE INTERVENTIONAL PROCEDURE, INCLUDING PROTHROMBIN TIME (PT, QUICK), ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), AND INTERNATIONAL NORMALIZED RATIO (INR). THE ARTICLE NOTES THAT ANTEGRADE ARTERIAL PUNCTURE WAS USED IN THE PATIENTS THAT PRESENTED WITH PSEUDOANEURYSM. TWO OF THESE PATIENTS HAD DERANGED COAGULATION PARAMETERS PRIOR TO THE INTERVENTIONAL PROCEDURE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. WITHOUT A STERILE LOT NUMBER, A DHR REVIEW COULD NOT BE CONDUCTED. THE EXOSEAL IFU LISTS PROLONGED ACCESS SITE-RELATED BLEEDING (HEMORRHAGE, HEMATOMA, PSEUDOANEURYSM) AS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. ACCESS SITE BLEEDS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. ADDITIONALLY, WITH THE AVAILABLE CLINICAL INFORMATION, IT COULD NOT BE DETERMINED IF ARTERIAL ACCESS WAS ACHIEVED WITH A SINGLE STICK OR IF MULTIPLE PUNCTURES WERE PRESENT. THERE IS ALSO NO INFORMATION REGARDING THE PATIENT¿S COMFORT LEVEL OR MOBILITY AT THE TIME OF THE EVENT. ADEQUATE SHEATH REMOVAL TECHNIQUE AND PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION ARE ROOT CAUSES OF PSEUDOANEURYSM AND HEMATOMA FORMATION. THE IFU ALSO STATES THAT THE SAFETY AND EFFECTIVENESS OF THE EXOSEAL DEVICE IN AN ANTEGRADE APPROACH HAS NOT BEEN ESTABLISHED. AN ANTEGRADE APPROACH MAY NOT ALLOW FOR PROPER VISUALIZATION OF THE ACTUAL ARTERIOTOMY SITE, AS THE IMAGING DYE WILL FLOW AWAY FROM THE ACTUAL ARTERIOTOMY SITE WITH THIS APPROACH. BASED ON THE LIMITED PROCEDURAL INFORMATION PROVIDED IN THE ARTICLE AND WITHOUT THE PRODUCTS AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS. HOWEVER, FACTORS INDICATED IN THE ARTICLE SUCH AS ¿DERANGEMENTS OF ANTICOAGULANT PARAMETERS¿ AND USE OF ANTEGRADE APPROACH MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE QUANTITY OF EVENTS REPORTED IS 3 (FOR 3 SEPARATE [PATIENTS) SPECIFIC PATIENT AND PROCEDURAL DETAILS ARE NOT AVAILABLE, INCLUDING PRODUCT INFORMATION, SUCH AS THE CATALOG AND LOT NUMBERS. THE CITATION IS AS FOLLOWS: SCHMELTER ET AL SUITABILITY OF EXOSEAL VASCULAR CLOSURE DEVICE FOR ANTEGRADE FEMORAL ARTERY PUNCTURE SITE CLOSURE, CARDIOVASCULAR INTERVENTIONAL RADIOLOGY 36 (2013) 659-668. CONCOMITANT MEDICAL PRODUCTS: X-RAY IMAGES SIEMENS MULTISTAR TOP FLUOROSCOPE (SIEMENS AG, (B)(4)). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY SCHMELTER ET AL SUITABILITY OF EXOSEAL VASCULAR CLOSURE DEVICE FOR ANTEGRADE FEMORAL ARTERY PUNCTURE SITE CLOSURE, CARDIOVASCULAR INTERVENTIONAL RADIOLOGY 36 (2013) 659-668; THERE WERE 13 CASES OF PSEUDOANEURYSM TREATED WITH ULTRASOUND GUIDED THROMBIN INJECTION, 1 CASE OF PSEUDOANEURYSM AND HEMATOMA, 2 CASES OF LATE BLEEDING, 1 CASE OF LATE BLEEDING AND HEMATOMA, AND 8 CASES OF HEMATOMA DURING/FOLLOWING USE OF AN EXOSEAL VASCULAR CLOSURE DEVICE. ONE CASE OF PSEUDOANEURYSM AND ALL CASES OF SIGNIFICANT LATER BLEEDING WERE TREATED WITH COMPRESSION BANDAGES. NO SURGICAL INTERVENTION WAS REQUIRED. ALL PATIENTS WITH PSEUDOANEURYSM AFTER THE INTERVENTIONAL PROCEDURE WERE CONSIDERED TO HAVE GRADE 4 PERIPHERAL VASCULAR DISEASE AND WERE TREATED WITH ANGIOPLASTY. THERE WERE ALSO 4 CASES OF BLEEDING AFTER 2 MINUTES OF MANUAL COMPRESSION,THERE WERE TWO PATIENTS WITH SIGNIFICANT LATE BLEEDING AFTER THE CONCLUSION OF THE CATHETERIZATION PROCEDURE AND 2 MIN OF MANUAL COMPRESSION. BOTH PATIENTS RECEIVED COMPRESSION BANDAGES ON THEIR FEMORAL ARTERIAL ACCESS SITES. BLEEDING OF THE VASCULAR ACCESS SITE AFTER 2 MIN OF MANUAL COMPRESSION WAS EVIDENT IN A SINGLE PATIENT WITH LATE PSEUDOANEURYSM. MANUAL COMPRESSION WAS CONTINUED IN THAT CASE UNTIL THE BLEEDING STOPPED, AND NO COMPRESSION BANDAGE WAS APPLIED. ANOTHER PATIENT WHO DEVELOPED A PSEUDOANEURYSM LATER ON WAS TREATED WITH A COMPRESSION BANDAGE ALTHOUGH BLEEDING AT THE VASCULAR ACCESS SITE HAD STOPPED WITHIN 2 MINUTES OF MANUAL COMPRESSION. . ALL THREE PATIENTS WITH SIGNIFICANT LATE BLEEDING SHOWED DERANGEMENTS OF THEIR COAGULATION PARAMETERS BEFORE THE INTERVENTIONAL PROCEDURE, INCLUDING DERANGEMENTS OF PROTHROMBIN TIME (PT, QUICK), ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), AND INTERNATIONAL NORMALIZED RATIO (INR). OF FOUR CASES WITH PSEUDOANEURYSM AFTER ANTEGRADE ARTERIAL PUNCTURE CLOSURE, THERE WERE TWO PATIENTS WITH DERANGED COAGULATION PARAMETERS BEFORE THE INTERVENTIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329920 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER: (6F) TERUMO DILATATOR