BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3133076 · Received May 29, 2013

    Report

    Report Number
    9616099-2013-00325
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 7, 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

    THE PATIENT¿S MEDICAL HISTORY, HEIGHT AND WEIGHT WERE UNKNOWN. THE PATIENT¿S MEDICAL REGIMEN INCLUDED ANTIPLATELET THERAPY. THE PATIENT WAS ANTICOAGULATED FOR THE PROCEDURE BUT THE ACT WAS NOT AVAILABLE. ANTIPLATELET THERAPY WAS ADMINISTERED DURING THE PROCEDURE. THE THROMBUS DESCRIBED WAS REPORTED TO BE UNRELATED TO THE EXOSEAL DEVICE OR ANY CORDIS PRODUCT AND WAS NOT RELATED TO THE EXOSEAL DEPLOYMENT PROCEDURE. THE EXOSEAL PLUG WAS CONFIRMED TO BE PLACED ACCURATELY AFTER THE PROCEDURE. THERE WAS NO REPORTED PROBLEM NOTED DURING DEPLOYMENT OF THE EXOSEAL DEVICE. THE PHYSICIAN WAS CERTIFIED IN USE OF THE EXOSEAL DEVICE. THE NUMBER OF CASES PERFORMED BY THE PHYSICIAN WAS NOT KNOWN. THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE DEVICE OR PACKAGING UPON INSPECTION PRIOR TO USE. THE EXOSEAL DEVICE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO PROBLEMS NOTED DURING PREPARATION. THE TARGET SITE FOR THE EXOSEAL DEVICE WAS NOT CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION WITHIN THIRTY DAYS PRIOR TO THE PROCEDURE. THERE WAS NO REPORTED EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. A 90% STENOSIS AT THE ACCESS SITE WAS NOTED. FILMS ARE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15762076 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE DAY AFTER SUCCESSFUL DEPLOYMENT OF A 7 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IN THE RIGHT FEMORAL ARTERY ACCESS SITE, THE PHYSICIAN NOTICED NO PULSE COULD BE FELT AT THE RIGHT DORSALIS PEDIS ARTERY AND BLOOD FLOW OBSTRUCTION WAS CONFIRMED IN RIGHT POPLITEAL ARTERY. THEREFORE, THROMBUS ASPIRATION WAS CONDUCTED VIA LEFT COMMON FEMORAL ARTERY APPROACH. HOWEVER THROMBUS WAS STILL OBSERVED AT THE RIGHT FEMORAL ARTERY BY IVUS. ASPIRATION AND BALLOON ANGIOPLASTY (POBA) WERE REPEATED, AND THE BLOOD FLOW WAS RECOVERED. AFTER TREATMENT, THE PATIENT WAS MAKING SATISFACTORY PROGRESS. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR THE LEFT COMMON ILIAC ARTERY AND LEFT EXTERNAL ILIAC ARTERY. THE APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY AND IT WAS RETROGRADE PUNCTURE. A NON-CORDIS GUIDING SHEATH WAS USED FOR THE PROCEDURE. THERE WAS 90% STENOSIS OBSERVED AT THE ACCESS SITE, BUT NO CALCIFICATION. AFTER THE PTA PROCEDURE, THE GUIDING SHEATH WAS EXCHANGED TO A (NON-CORDIS) SHORT SHEATH INTRODUCER. THE 7 FR. EXOSEAL DEVICE WAS INSERTED INTO THE SHEATH INTRODUCER AND CONNECTED. AN ADEQUATE BLEED-BACK SIGNAL FROM THE BLEED BACK INDICATOR WAS CONFIRMED, AND THE EXOSEAL DEVICE WITH THE SHEATH WAS RETRACTED UNTIL THE BLEED BACK HAD VISIBLY REDUCED AND THE INDICATOR WINDOW WAS NOTED TO HAVE CHANGED TO A BLACK-BLACK PATTERN. THEN THE PHYSICIAN PRESSED THE PLUG DEPLOYMENT BUTTON, AND THE PLUG WAS DEPLOYED NORMALLY. AFTER THE PLUG DEPLOYMENT, LIGHT PRESSURE WAS APPLIED TO THE PUNCTURE SITE FOR APPROXIMATELY TEN (10) MINUTES AND HEMOSTASIS WAS ACHIEVED WITH THE EXOSEAL DEVICE. THE PHYSICIAN¿S COMMENT: ¿AT FIRST, THE PLUG WAS SUSPECTED TO BE PLACED INTRAVASCULAR AND OCCLUDED THE RIGHT FEMORAL ARTERY. BUT IT WAS CONFIRMED AS A THROMBOTIC OCCLUSION BECAUSE THERE WAS NO HEMORRHAGE OBSERVED FROM THE PLUG IMPLANTED SITE AND HEMOSTASIS WAS ACHIEVED/MAINTAINED WITH THE EXOSEAL DEVICE¿.THE PATIENT¿S MEDICAL HISTORY, HEIGHT AND WEIGHT WERE UNKNOWN. THE PATIENT¿S MEDICAL REGIMEN INCLUDED ANTIPLATELET THERAPY. THE PATIENT WAS ANTICOAGULATED FOR THE PROCEDURE BUT THE ACT WAS NOT AVAILABLE. ANTIPLATELET THERAPY WAS ADMINISTERED DURING THE PROCEDURE. THE THROMBUS DESCRIBED WAS REPORTED TO BE UNRELATED TO THE EXOSEAL DEVICE OR ANY CORDIS PRODUCT AND WAS NOT RELATED TO THE EXOSEAL DEPLOYMENT PROCEDURE. THERE WAS NO REPORTED PROBLEM NOTED DURING DEPLOYMENT OF THE EXOSEAL DEVICE. THE PHYSICIAN WAS CERTIFIED IN USE OF THE EXOSEAL DEVICE. THE NUMBER OF CASES PERFORMED BY THE PHYSICIAN WAS NOT KNOWN. THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE DEVICE OR PACKAGING UPON INSPECTION PRIOR TO USE. THE EXOSEAL DEVICE WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO PROBLEMS NOTED DURING PREPARATION. THE TARGET SITE FOR THE EXOSEAL DEVICE WAS NOT CLOSED WITH ANY CLOSURE DEVICE OR MANUAL COMPRESSION WITHIN THIRTY DAYS PRIOR TO THE PROCEDURE. THERE WAS NO REPORTED EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO EXOSEAL VCD USE. A 90% STENOSIS AT THE ACCESS SITE WAS NOTED. FILMS ARE NOT AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15762076 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. PERIPHERAL ARTERY OCCLUSION AND LOWER EXTREMITY ARTERIAL EMBOLI ARE LISTED AS SERIOUS POTENTIAL RISKS ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. WHILE THERE DO NOT APPEAR TO BE ANY OVERT PROCEDURAL DEVICE RELATED FACTORS THAT CAN BE ATTRIBUTED TO THE REPORTED EVENT, THE SAFETY AND EFFECTIVENESS OF THE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WHO WITHIN = 1 CM OF THE PUNCTURE SITE HAVE FLUOROSCOPICALLY VISIBLE CALCIUM, ATHEROSCLEROTIC DISEASE, OR A STENT. IT WAS REPORTED THAT THERE WAS 90% STENOSIS AT THE ACCESS SITE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE THROMBUS FORMED IN THE AFFECTED LEG RESULTING IN ARTERIAL OCCLUSION. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. 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.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE DAY AFTER SUCCESSFUL DEPLOYMENT OF A 7 FR. EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IN THE RIGHT FEMORAL ARTERY ACCESS SITE, THE PHYSICIAN NOTICED NO PULSE COULD BE FELT AT THE RIGHT DORSALIS PEDIS ARTERY AND BLOOD FLOW WAS NOT CONFIRMED FROM THE RIGHT POPLITEAL ARTERY. THEREFORE, THROMBUS AT THE RIGHT FEMORAL ARTERY WAS ASPIRATED BY LEFT COMMON FEMORAL ARTERY APPROACH. HOWEVER THROMBUS WAS STILL OBSERVED AT THE RIGHT FEMORAL ARTERY BY IVUS. ASPIRATION AND BALLOON ANGIOPLASTY (POBA) WERE REPEATED, AND THE BLOOD FLOW WAS RECOVERED. AFTER THE TREATMENT, THE PATIENT WAS MAKING SATISFACTORY PROGRESS. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR THE LEFT COMMON ILIAC ARTERY AND LEFT EXTERNAL ILIAC ARTERY. THE APPROACH WAS MADE FROM THE RIGHT COMMON FEMORAL ARTERY AND IT WAS RETROGRADE PUNCTURE. A NON-CORDIS GUIDING SHEATH WAS USED FOR THE PROCEDURE. THERE WAS 90% STENOSIS OBSERVED AT THE ACCESS SITE, BUT NO CALCIFICATION. AFTER THE PTA PROCEDURE, THE GUIDING SHEATH WAS EXCHANGED TO A (NON-CORDIS) SHORT SHEATH INTRODUCER. THE 7 FR. EXOSEAL DEVICE WAS INSERTED INTO THE SHEATH INTRODUCER AND CONNECTED. AN ADEQUATE BLEED-BACK SIGNAL FROM THE BLEED BACK INDICATOR WAS CONFIRMED, AND THE EXOSEAL DEVICE WITH THE SHEATH WAS RETRACTED UNTIL THE INDICATOR WINDOW WAS NOTED TO HAVE CHANGED TO A BLACK-BLACK PATTERN. THEN THE PHYSICIAN PRESSED THE PLUG DEPLOYMENT BUTTON, AND THE PLUG WAS DEPLOYED NORMALLY. AFTER THE PLUG DEPLOYMENT, LIGHT PRESSURE WAS APPLIED TO THE PUNCTURE SITE FOR APPROXIMATELY TEN (10) MINUTES AND HEMOSTASIS WAS ACHIEVED WITH THE EXOSEAL DEVICE. THE PHYSICIAN¿S COMMENT: AT FIRST, THE PLUG WAS SUSPECTED TO BE PLACED INTRAVASCULAR AND OCCLUDED THE RIGHT FEMORAL ARTERY. BUT IT WAS CONFIRMED AS A THROMBOTIC OCCLUSION BECAUSE THERE WAS NO HEMORRHAGE OBSERVED FROM THE PLUG IMPLANTED SITE AND HEMOSTASIS WAS ACHIEVED/MAINTAINED WITH THE EXOSEAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235984 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15762076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MEDIKIT'S 7F/11CM SHEATH