BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2900112 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00123
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    January 1, 2004
    Report Date
    December 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.(B)(4): CONCOMITANT MEDICAL PRODUCTS:GUIDE WIRE: STANDARD 0.035 GUIDEWIRE, AMPLATZ SUPER-STIFF WIRE.SHEATH: 9FR, 18 FR.OTHER: 21G MICROLANCE NEEDLE, MOSQUITO CLAMP, MEDTRONIC CORE VALVE SYSTEM. THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL DEVICE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH ANTEGRADE PUNCTURES.THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.LARGE CALIBRE ARTERIAL ACCESS DEVICE CLOSURE FOR PERCUTANEOUS AORTIC VALVE INTERVENTIONS: USE OF THE PROSTAR SYSTEM IN 118 CASES. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 79:143-149, 2012. JAMES COCKBURN, MBBS, MD, MRCP, ADAM DE BELDER, MBBS, MD, MRCP, MICHAEL BROOKS, MBBS, FRCA, NEVIL HUTCHINSON, MBBS, FRCA, ANDREW HILL, MBBS, FRCA, UDAY TRIVEDI, MBBS, FRCS, AND DAVID HILDICK-SMITHMBBS, MD, FRCP. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY DATABASE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    A PROSPECTIVE REVIEW OF PROCEDURAL DATA AND OUTCOMES COLLECTED FROM A DEDICATED DATABASE WAS PERFORMED IN 118 PATIENTS WHO UNDERWENT BALLOON AORTIC VALVULOPLASTY (BAV=54 PATIENTS/54 FEMORAL ARTERIES. FIFTY TWO WERE ANTEGRADE AND 2 WERE RETROGRADE PUNCTURES) AND TRANS-CATHETER AORTIC VALVE IMPLANTATION (TAVI=64. ALL ANTEGRADE PUNCTURES). THE PROSTAR XL DEVICE WAS USED USING THE PRECLOSE TECHNIQUE FOR VASCULAR CLOSURE. COMPLICATIONS IN THE TAVI GROUP WERE: MAJOR BLEEDING WAS SEEN IN 4.7% (3/64) OF CASES. DURING ONE OF THE MAJOR BLEEDING CASES, THE PATIENT ON INITIAL IMPLANTATION OF THE PROSTAR XL DEVICE INTO THE ARTERY THE INTRODUCER TOOK A SUBCUTANEOUS COURSE LEADING TO SIGNIFICANT ABDOMINAL TRACKING. THE DEVICE WAS SUCCESSFULLY RE-INTRODUCED INTO THE ARTERY. FOLLOWING THE TAVI, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE PROSTAR XL BUT BECAUSE OF THE ABDOMINAL DEVICE TRACKING, THE SURGEON CHOSE TO VISUALIZE THE ENTRY SITE DIRECTLY AND PLACE ADDITIONAL SUTURES. THREE HOURS POST PROCEDURE, THE PATIENT BECAME HYPOTENSIVE WITH SOME LOIN PAIN. THE PATIENT WAS TAKEN BACK TO CATHETER LABORATORY AND AN ANGIOGRAM CONFIRMED A SMALL ONGOING LEAK AT THE ENTRY POINT OF THE COMMON FEMORAL ARTERY. AN OCCLUSION BALLOON WAS INTRODUCED FROM THE CONTRALATERAL FEMORAL ARTERY AND GENTLY INFLATED TO LOW PRESSURE FOR 30 MIN, WITH DEFLATION FOR 30 SECONDS EVERY 5 MINUTES TO ALLOW LIMB PERFUSION. THIS SUCCESSFULLY ALLOWED THE LEAK TO SEAL. INTRAVENOUS GLYCERYL TRINITRATE INFUSION TO KEEP THE SYSTOLIC BLOOD PRESSURE BELOW 120 MM HG WAS USED FOR 12 HOURS AND THERE WERE NO FURTHER COMPLICATIONS. THE PHYSICIANS ARE REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6246 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention CONCOMITANT MEDICAL DEVICES