BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL STS PLUS

    MDR report key: 3032433 · Received March 29, 2013

    Report

    Report Number
    3003681312-2013-00018
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) WARNS, DO NOT USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY. THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA). THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT BASED ON CLINICAL EXPERIENCE, THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES, IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THE USE OF THE ANGIO-SEAL IN PEDIATRIC PATIENTS OR OTHERS WITH SMALL FEMORAL ARTERY SIZE (<4MM IN DIAMETER). SMALL FEMORAL ARTERY SIZE MAY PREVENT THE ANGIO-SEAL ANCHOR FROM DEPLOYING PROPERLY IN THESE PTS.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO CLOSE A RETROGRADE PUNCTURE FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PT WAS BEING TREATED FOR CHRONIC TOTAL OCCLUSION (CTO) OF THE LEFT ANTERIOR DESCENDING ARTERY. A PRE-DEPLOYMENT ANGIOGRAM REVEALED NO ANOMALIES. IMMEDIATELY AFTER DEPLOYMENT, THE PT HAD ABSENT PULSES AND WAS DIAGNOSED WITH A VESSEL OCCLUSION. A POST-OP ECHOGRAM REVEALED MINIMAL BLOOD FLOW THROUGH THE AFFECTED ARTERY. THE FOLLOWING DAY, ANOTHER ECHOGRAM SHOWED NORMAL BLOOD FLOW HAD BEEN RESTORED AND THE ANCHOR AND COLLAGEN WERE DEPLOYED IN THE CORRECT POSITION WITH NO SIGN OF THROMBUS. THE PHYSICIAN STATED THAT THIS EVENT WAS LIKELY CAUSED BY A FEMORAL ARTERY SPASM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129848 6F ANGIO-SEAL STS PLUS DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO NA 3845630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R