BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR CLOSURE DEVICE 7F -

    MDR report key: 8799603 · Received July 17, 2019

    Report

    Report Number
    9616099-2019-03083
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 12, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MGB
    UDI-DI
    20705032058893
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE SECTIONS HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, THIS WAS A CAROTID ARTERY STENTING (CAS) CASE, A 7F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS USED FOR HEMOSTASIS, TWO MONTHS AFTER THE PATIENT COMPLAINED OF FOOT PAIN. IT WAS OBSERVED THAT POLYGLYCOLIC ACID (PGA) FROM THE PLUG WAS IMPLANTED IN THE BLOOD VESSEL. THERE WERE NO ADDITIONAL REPORTED PATIENT INJURIES. FLUORESCEIN ANGIOGRAPHY (FAG) WAS PERFORMED. PRE-INTRAVASCULAR ULTRASOUND (IVUS) AND SUCTION WAS PERFORMED. A BIOPSY AND A NON-CORDIS BALLOON CATHETER WERE USED FOR POST IVUS. A BIOPSY WAS INSERTED TO THE PATIENT TO TAKE SOME TISSUES OF THE STENOSIS PART. IT WAS BROUGHT TO LAB OF THE HOSPITAL TO DECIDE ON IF IT WAS PGA. IT WAS NOT CONFIRMED BY PRE-IVUS. AFTER THE NON-CORDIS BALLOON CATHETER WAS INFLATED. IT WAS CONFIRMED THAT THE STENOSIS PART WAS BLACK, AND IT SEEMS NOT TO BE A PLAQUE. THE PHYSICIAN COMMENTED THAT IT SEEMS TO BE ORGANIZED THROMBUS AND PGA. ABOUT TWO MONTHS HAVE PASSED SINCE THE PROCEDURE, BUT IT MAY NOT HAVE BEEN RESOLVED BECAUSE THE BLOOD FLOW WAS BLOCKED. THE SUPERFICIAL FEMORAL ARTERY (SFA) HAD NINETY NINE PERCENT STENOSIS. IT WAS NOT THROMBUS BUT PGA. IF IT WAS PGA, IT IS VERY LIKELY THAT PGA WAS IMPLANTED IN THE BLOOD VESSEL. HOWEVER, IT COULD NOT IDENTIFY AT THIS STAGE, SO WAIT FOR THE RESULT FROM THE LAB OF THE HOSPITAL. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17826351 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿PLUG INACCURATE PLACEMENT INTRAVASCULAR¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND PROCEDURAL IMAGES WERE NOT PROVIDED. THE EXACT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. A THROMBOSIS CAN BE CAUSED BY DISLODGED THROMBUS EMBOLIZING, OR IT CAN BE CAUSED BY THE PLUG BEING DEPLOYED INTRAVASCULARLY, EITHER PARTIALLY OR COMPLETELY, AND A THROMBUS DEVELOPING AT THE DEPLOYED AREA. AN ARTERIAL THROMBOSIS WOULD MOST LIKELY REQUIRE ADDITIONAL INTERVENTION, SUCH AS THROMBECTOMY, STENTING, OR SURGICAL INTERVENTION IN ORDER TO RESTORE/IMPROVE FLOW. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW IN REGARDS TO THE DEPLOYMENT OF THE EXOSEAL, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE SUSPECTED INTRAVASCULAR DEPLOYMENT OF THE PLUG AND THE SUBSEQUENT THROMBOSIS. HOWEVER, IT¿S POSSIBLY RELATED TO PATIENT FACTORS AND HANDLING FACTORS. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿PHYSICIANS SHOULD BE ALERTED TO THE FOLLOWING: EXCESSIVE BLEEDING, SWELLING OF THE GROIN OR LEG, PAIN IN THE GROIN OR LEG OR ANY SIGN OF INFECTION (REDNESS, SWELLING, DRAINAGE, WARMTH, FEVER, CHILLS, NON-HEALING OF WOUND).¿ NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 17826351 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THIS WAS A CAROTID ARTERY STENTING (CAS) CASE, AN EXOSEAL 7F WAS USED FOR HEMOSTASIS, TWO MONTHS AFTER THE PATIENT COMPLAINED OF FOOT PAIN. IT WAS OBSERVED THAT POLYGLYCOLIC ACID (PGA) FROM THE PLUG WAS IMPLANTED IN THE BLOOD VESSEL. THERE WERE NO REPORTED PATIENT INJURIES. FLUORESCEIN ANGIOGRAPHY (FAG) WAS PERFORMED. PRE INTRAVASCULAR ULTRASOUND (IVUS) AND SUCTION WAS PERFORMED. A BIOPSY AND A NON-CORDIS BALLOON CATHETER WERE USED FOR POST IVUS. A BIOPSY WAS INSERTED TO THE PATIENT TO TAKE SOME TISSUES OF THE STENOSIS PART. IT WAS BROUGHT TO LAB OF THE HOSPITAL TO DECIDE ON IF IT WAS PGA. IT WAS NOT CONFIRMED BY PRE-IVUS. AFTER THE NON-CORDIS BALLOON CATHETER WAS INFLATED. IT WAS CONFIRMED THAT THE STENOSIS PART WAS BLACK, AND IT SEEMS NOT TO BE A PLAQUE. THE PHYSICIAN COMMENTED THAT IT SEEMS TO BE ORGANIZED THROMBUS AND PGA. ABOUT TWO MONTHS HAVE PASSED SINCE THE PROCEDURE, BUT IT MAY NOT HAVE BEEN RESOLVED BECAUSE THE BLOOD FLOW WAS BLOCKED. THE SUPERFICIAL FEMORAL ARTERY (SFA)HAD NINETY NINE PERCENT STENOSIS. IT WAS NOT THROMBUS BUT PGA. IF IT WAS PGA, IT IS VERY LIKELY THAT PGA WAS IMPLANTED IN THE BLOOD VESSEL. HOWEVER, IT COULD NOT IDENTIFY AT THIS STAGE, SO WAIT FOR THE RESULT FROM THE LAB OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593188 VASCULAR CLOSURE DEVICE 7F - DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS CORPORATION 17826351 20705032058893

    Patients

    Seq Age Sex Outcome Treatment
    1