BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2900131 · Received January 7, 2013

    Report

    Report Number
    2024168-2013-00124
    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
    Product Problem
    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)(6). DATE OF EVENT ESTIMATED. THE ARTICLE INDICATES THE PROCEDURES WERE PERFORMED BETWEEN 2004 AND 2010. DESPITE BEING SENT HOME WITH ORAL CO-AMOXICLAV THE PATIENT DEVELOPED A SUPERFICIAL WOUND INFECTION REQUIRING READMISSION UNDER THE GENERAL SURGEONS, TREATED WITH FURTHER IV ANTIBIOTICS. THE PHYSICIANS ARE REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: STANDARD 0.035 GUIDEWIRE, AMPLATZ SUPER-STIFF WIRE, SHEATH: 9FR, 18FR, 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.

    Additional Manufacturer Narrative · 1

    (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 (B)(4) PATIENTS WHO UNDERWENT BALLOON AORTIC VALVULOPLASTY (BAV = (B)(4) PATIENTS/(B)(4) FEMORAL ARTERIES. (B)(4) 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 (B)(4) OF CASES. DURING ONE OF THE MAJOR BLEEDING CASES, AFTER PLACEMENT OF THE PROSTAR XL DEVICE WITHOUT COMPLICATION, THE 18F INTRODUCER SHEATH COULD ONLY BE ADVANCED A FEW CENTIMETERS INTO THE COMMON FEMORAL ARTERY. THE COREVALVE SYSTEM WAS ADVANCED WITHOUT DIFFICULTY AND VALVE IMPLANTATION WAS UNDERTAKEN WITHOUT COMPLICATION. ON REMOVAL OF THE 18F SHEATH HOWEVER, BLEEDING OCCURRED AND THE SURGEON DECIDED TO EXPLORE THE VESSEL. DISRUPTED CALCIFIC PLAQUE WAS SEEN ON SURGICAL EXPLORATION AND ARTERIAL CLOSURE WAS DIFFICULT. FOLLOWING SURGICAL CLOSURE, AN ANGIOGRAM SHOWED THAT THE COMMON FEMORAL ARTERY WAS OCCLUDED ABOVE THE CLOSURE. A VASCULAR SURGEON REPAIRED THE COMMON FEMORAL ARTERY WITH A LONGITUDINAL ARTERECTOMY AND BOVINE PERICARDIAL PATCH USING PROLENE SUTURES. ON TABLE REPEAT FEMORAL ANGIOGRAPHY CONFIRMED RESTORATION OF NORMAL BLOOD FLOW WITHIN THE VESSEL. THE PROCEDURAL TIME INCLUDING VASCULAR REPAIR WAS 3 HOURS AND 20 MINUTES. THE PATIENT WAS TREATED WITH A FURTHER SUBCUTANEOUS BOLUS OF 5,000 UNITS OF HEPARIN BD AND 1.2 G TDS OF IV CO-AMOXICLAV TO COVER FOR INFECTION FOR 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6455 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R