BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3140654 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03420
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. EVENT DESCRIPTION CONTINUED: A NON-ABBOTT SHEATH WAS PLACED AND A 3.0 X 16 MM GRAFTMASTER SDS WAS ADVANCED TO THE AREA OF EXTRAVASATION AND CAREFULLY DEPLOYED TO 22 ATMOSPHERE (ATM) RESULTING IN EXCELLENT APPOSITION. TIMI 3 FLOW AND 0% RESIDUAL STENOSIS AND NO EVIDENCE OF EXTRAVASATION OF DYE THROUGH THE STENTED SEGMENT. ALL DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: VICTORY 0.014; SHEATH: COOK CXI 0.018 MICROSHEATH. (B)(4) - INDICATION FOR USE, CORONARY STENT USED IN THE PERIPHERAL VESSEL. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE, STATES THAT THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. THE EFFECTIVENESS OF THIS DEVICE FOR THIS USE HAS NOT BEEN DEMONSTRATED. LONG-TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A PERFORATION THAT OCCURRED IN THE RIGHT POSTERIOR TIBIAL ARTERY WITH THE USE OF A NON-ABBOTT DEVICE. A 3.0 X 26 GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE FEMORAL SHEATH IN ANTEGRADE FASHION. ONCE PAST THE DISTAL POPLITEAL ARTERY THE SDS WAS UNABLE TO PASS INTO THE TIBIAL ARTERY SO THE DECISION WAS MADE TO REMOVE THE STENT, HOWEVER, IT GOT CAUGHT UP IN THE STRUTS OF THE FEMORAL STENTS AND DISLODGED FROM THE BALLOON. THE STENT WAS LOCATED UNDER FLUOROSCOPY REMAINING ON THE GUIDE WIRE IN THE PROXIMAL/MID SUPERFICIAL FEMORAL ARTERY (SFA). MANUAL PRESSURE ON THE BALLOON WAS HELD AT THE STENT SITE TO PREVENT DISTAL EMBOLIZATION AND A NON-ABBOTT GOOSENECK SNARE WAS PLACED AND AFTER MULTIPLE ATTEMPTS THE STENT WAS SNARED AT THE PROXIMAL AREA AND SUCCESSFULLY PULLED BACK AND REMOVED FROM THE SHEATH AND OUT OF THE ANATOMY. AT THIS POINT, A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) AND NON-ABBOTT GUIDE WIRE WERE INSERTED THROUGH THE FEMORAL ARTERY INTO THE DISTAL SFA/TIBIAL ARTERY AND A 3.5 X 60 NON-ABBOTT STENT WAS PLACED INTO THE BIFURCATION OF THE POSTERIOR TIBIAL ARTERY AND INFLATED AT 2 ATMOSPHERE (ATM) AND AT 6 ATM ADDITIONAL 3 ATM TO IMPROVE THE RESIDUAL STENOSIS AND ALLOW PASSING OF FURTHER EQUIPMENT. A STRAIGHT TIPPED 5 FR NON-ABBOTT GUIDE WIRE WAS ADVANCED INTO THE DISTAL ARTERY AND A NON-ABBOTT SHEATH WITH A DILATOR WAS ADVANCED TO THE POPLITEAL ARTERY TO ALLOW ADDITIONAL SUPPORT FOR THE COVERED STENT TO BE DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242074 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 726928

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention