BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIGO-SEAL DEVICE

    MDR report key: 1241296 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00253
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    December 1, 2007
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WERE NOT POSSIBLE SINCE THE LOT NUMBERS WERE UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. FOR THE ADVERSE EVENTS REPORTED IN THIS ARTICLE, THE FOLLOWING INFO WAS NOT AVAILABLE: COUNTRY, FACILITY/HOSPITAL, PHYSICIAN, PATIENT INFO/MEDICAL BACKGROUND, PRODUCT MODEL AND/OR LOT NUMBER. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEARS, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT IF COLLAGEN DEPOSITION INTO THE ARTERY AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVE, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATES FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING, THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A META-ANALYSIS LITERATURE ARTICLE, "VASCULAR OCCLUSION AS A LATE COMPLICATION OF THE ANGIO-SEAL CLOSURE DEVICE," MINERVA CARDIOANGIOLOGIA 2007 WRITTEN BY T. VAN DEN BROEK, ET AL, THAT FOLLOWING PERCUTANEOUS ANGIOGRAPHIC PROCEDURES, ANGIO-SEAL CLOSURE DEVICES WERE USED. THE PATIENTS MENTIONED IN THIS ARTICLE EXPERIENCED LATE VASCULAR OCCLUSION AS A COMPLICATION AND ARE DESCRIBED BELOW. THERE IS NO ADDITIONAL INFO AVAILABLE REGARDING PHYSICIAN, HOSPITAL, OR COUNTRY WHERE THE EVENTS OCCURRED. ONE PATIENT DEVELOPED CRITICAL ISCHEMIA OF THE LEG 5 WEEKS AFTER ANGIO-SEAL DEPLOYMENT. SURGICAL EXPLORATION WAS NECESSARY AND REVEALED A REABSORPTION OF THE COLLAGEN PLUG AND ANCHOR OF THE ANGIO-SEAL DEVICE. ALLEGEDLY, THIS REABSORPTION HAD BEEN TRANSFORMED INTO PERI-ARTERIAL AND INTRA-ARTERIAL FIBROSIS WHICH WAS THE CAUSE FOR THE COMMON FEMORAL ARTERY OCCLUSION. ONE PT DEVELOPED CLAUDICATION 3 MONTHS LATER. AFTER DEOBSTRUCTION OF THE FEMORAL STENOSIS BY BALLOON DILATATION, A REDUCED BLOOD FLOW IN THE SUPERFICIAL FEMORAL ARTERY WAS IDENTIFIED. DURING THIS PROCEDURE, THE PREVIOUSLY USED ANGIO-SEAL ANCHOR HAD EMBOLIZED DOWNSTREAM IN THE ARTERY. THE ALLEGED ANCHOR WAS SNARED AND RETRIEVED TO THE LEVEL OF THE EXTERNAL ILIAC ARTERY WHERE IT WAS SURGICALLY REMOVED. ONE PATIENT EXPERIENCED DIMINISHED DORSALIS AND MALLEOLAR PULSES AND HAD AN AUDIBLE BRUIT OVER THE GROIN. FOUR WEEKS LATER, THE PATIENT EXPERIENCED PROGRESSIVE CLAUDICATION AND PAIN AT REST. THE PATIENT WAS DIAGNOSED WITH FEMORAL ARTERY THROMBOSIS AND UNDERWENT SURGICAL INTERVENTION. THE ANGIO-SEAL WAS REMOVED. THE PATIENT'S COMPLAINTS WERE RELIEVED. ONE PATIENT EXPERIENCED SYMPTOMS OF AN ARTERIAL STENOSIS TWENTY FOUR HOURS LATER WHICH PROGRESSIVELY WORSENED OVER A 6 WEEK PERIOD. TWO SEQUENTIAL BALLOON DILATION PROCEDURES DID NOT IMPROVE THE LESION IN THE COMMON FEMORAL ARTERY. A SUCCESSFUL ATHERECTOMY WAS PERFORMED USING A LSF SILVERHAWK CATHETER. TWO PATIENTS WERE DIAGNOSED WITH VASCULAR STENOSIS. THE FIRST EXPERIENCED PAIN AND A PALE COLD LEG NINE DAYS LATER AND WAS TREATED WITH SURGERY. THE SECOND PATIENT EXPERIENCED PAIN AT REST NINETEEN DAYS LATER AND WAS TREATED WITH A SMALL ARTERIOTOMY AND MEDICATION. THREE PATIENTS EXPERIENCED ASYMPTOMIC COMMON FEMORAL ARTERY OCCLUSIONS. THE FIRST PATIENT WAS DIAGNOSED DURING A SUBSEQUENT TRANSFEMORAL CEREBRAL ANGIOGRAPHIC PROCEDURE. THIS PATIENT HAD COLLATERAL CIRCULATION, SO NO TREATMENT FOR THE VESSEL OCCLUSION WAS PERFORMED. THE SECOND PATIENT WAS DIAGNOSED WITH A FILLING DEFECT ON ANGIOGRAPHY TEN WEEKS LATER AND UNDERWENT SUCCESSFUL BALLOON DILATION AT THE SITE. THE THIRD PATIENT EXPERIENCED AN ASYMPTOMIC COMMON FEMORAL ARTERY OCCLUSION ON THE SIDE OF THE ANGIO-SEAL BUT THE ARTICLE DID NOT DISCUSS PATIENT TREATMENT. ONE PATIENT EXPERIENCED CLAUDICATION 2 MONTHS FOLLOWING THE PROCEDURE, ALLEGEDLY, AT THE SITE OF THE ANGIO-SEAL DEPLOYMENT. SURGICAL INTERVENTION REVEALED FOCAL INTIMAL HYPERPLASIA IN THE COMMON FEMORAL ARTERY. AN ENDARTERECTOMY AND PATCH ANGIOPLASTY ELIMINATED THE CLAUDICATION. FOUR PATIENTS DEVELOPED CHRONIC LEG ISCHEMIA WITH CLAUDICATION 1 WEEK FOLLOWING THE PROCEDURE. SURGICAL INTERVENTION REMOVED THE DISLODGED ANCHOR AND A LOOSE INTIMAL FLAP. AN ENDARTERECTOMY AND THROMBECTOMY FOLLOW BY PATCH ANGIOPLASTY OR DIRECT SUTURE OF THE ARTERY WERE PERFORMED. THIRTY FOUR PATIENTS DEVELOPED SYMPTOMS OF PERIPHERAL ARTERY DISEASE. SOME PATIENTS DEVELOPED SYMPTOMS 1 TO 14 DAYS LATER AND WERE TREATED WITH EXCIMER LASER ANGIOPLASTY. IN THE REMAINDER 10 PATIENTS, TREATMENT WAS NOT DISCUSSED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIGO-SEAL DEVICE ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R