BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1000480 · Received February 21, 2008

    Report

    Report Number
    2182269-2008-00056
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    December 11, 2007
    Report Date
    February 13, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBUS 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 STATES IF PATIENT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, 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 STATE FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY. THE IFU CAUTION THAT THE ANGIO-SEAL DEVICE IS TO BE USED ONLY BY A LICENSED PHYSICIAN (OR OTHER HEALTH CARE PROFESSIONAL AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIAN) POSSESSING ADEQUATE INSTRUCTION IN THE USE OF THE DEVICE, E.G., PARTICIPATION IN AN ANGIO-SEAL PHYSICIAN INSTRUCTION PROGRAM OR EQUIVALENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PRE-DEPLOYMENT FEMORAL ANGIOGRAM REVEALED COMMON FEMORAL ARTERY (CFA) ACCESS WITH NO VISIBLE PLAQUE NEAR THE ENTRY SITE. A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AFTER A PERIPHERAL INTERVENTIONAL PROCEDURE AND DEPLOYMENT WAS UNREMARKABLE. HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS RELEASED WITH NO COMPLAINTS. THIRTEEN DAYS LATER AT A ROUTINE FOLLOW-UP EXAM, THE PATIENT DESCRIBED A NEW ONSET OF REST PAIN IN THE LEG WHICH BEGAN AFTER THE PROCEDURE. THE PT HAS CHRONIC PERIPHERAL DISEASE AND WAS USED TO DEALING WITH GENERALIZED PAIN, SO JUST DEALT WITH THIS NEW POST PROCEDURE PAIN. THE PHYSICIAN EXAM REVEALED CLINICAL EVIDENCE OF FEMORAL THROMBOSIS; THERE WAS NO FEMORAL PULSE. THE PATIENT WENT DIRECTLY TO SURGERY. THE SURGICAL FINDINGS INCLUDED THE INTRALUMINAL DEVICE (BOTH ANCHOR AND COLLAGEN) WITH SIGNIFICANT PLAQUE IN THE NATIVE ARTERY. THE PHYSICIAN'S SPECULATION IS THAT THE ANCHOR CAUGHT IN THE POSTERIOR PLAQUE, THAT WAS NOT APPRECIATED IN THE PRE-DEPLOYMENT FEMORAL ANGIOGRAM, RESULTING IN DEPOSITION OF THE ENTIRE DEVICE IN THE ARTERY. THE PHYSICIAN'S ANGIO-SEAL VIP TRAINING WAS IN PROGRESS AT THE TIME OF THIS DEPLOYMENT. HIS TRAINING ON ANGIO-SEAL VIP IS NOW COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention