BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3071414 · Received April 22, 2013

    Report

    Report Number
    2024168-2013-02480
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 8, 2012
    Report Date
    April 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DB DEPLOYMENT AND COVERED STENT PLACEMENT WERE TECHNICALLY SUCCESSFUL IN ALL PATIENTS, EXCEPT ONE PATIENT IN GROUP B IN WHOM THE COVERED STENT FAILED TO NAVIGATE TO THE TARGET DCCF. NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN THE TWO GROUPS IN TECHNICAL SUCCESS, MORTALITY, MORBIDITY OR FINAL CLINICAL OUTCOMES. IN THIS NONRANDOMIZED, PROSPECTIVE STUDY OF POSTTRAUMATIC DCCF TREATMENT, THE 12-MONTH ANGIOGRAPHIC RESULTS OF TREATMENT WITH COVERED STENTS WAS SUPERIOR. IT WAS REPORTED THAT BETWEEN (B)(6) 2007 AND (B)(6) 2011, 15 PATIENTS (9 MALE) UNDERWENT TREATMENT FOR AN EXISTING POSTTRAUMATIC DIRECT CAROTID-CAVERNOUS FISTULA (DCCF) OF THE INTERNAL CAROTID ARTERY, USING AN UNSPECIFIED JOSTENT GRAFTMASTER COVERED STENT. AFTER THE 12-MONTH STUDY PERIOD, AN UNSPECIFIED NUMBER OF PATIENTS WITH RESIDUAL OR RECURRENT CAROTID-CAVERNOUS FISTULAS OR PSEUDOANEURYSMS WERE TREATED WITH DETACHABLE BALLOON, COILING, OR COVERED STENTS. NO ADDITIONAL INFORMATION WAS NOTED. GUIDE WIRE: BOSTON SCIENTIFIC TRANSCEND FLOPPY. GUIDE CATHETER: 6-FRENCH CORDIS ENVOY. (B)(4) - INCORRECT ANATOMY. ARTICLE: COMPARISON OF COVERED STENTS WITH DETACHABLE BALLOONS FOR TREATMENT OF POSTTRAUMATIC CAROTID-CAVERNOUS FISTULAS", BO YIN, HAN-SONG SHENG, RUI-LI WEI, JIAN LIN, HUI ZHOU, NU ZHANG. (JOURNAL OF CLINICAL NEUROSCIENCE(0967-5868) 2013 20(3):367-372). 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THAT THE RX GRAFTMASTER INSTRUCTIONS FOR USE (IFU) STATES THAT THE JOSTENT GRAFTMASTER IS A BALLOON-EXPANDABLE PRE-MOUNTED CORONARY STENT GRAFT FOR INTRALUMINAL CHRONIC PLACEMENT IN CORONARY ARTERIES OR AORTO-CORONARY BYPASS GRAFTS FOR THE TREATMENT OF: CORONARY ARTERY ANEURYSM, CORONARY BYPASS-VEIN GRAFT ANEURYSM, ACUTE CORONARY ARTERY PERFORATION AND ACUTE CORONARY ARTERY RUPTURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE FOLLOWING ARTICLE: "COMPARISON OF COVERED STENTS WITH DETACHABLE BALLOONS FOR TREATMENT OF POSTTRAUMATIC CAROTID-CAVERNOUS FISTULAS", BO YIN, HAN-SONG SHENG, RUI-LI WEI, JIAN LIN, HUI ZHOU, NU ZHANG. (JOURNAL OF CLINICAL NEUROSCIENCE(0967-5868) 2013 20(3):367-372). BACKGROUND: TREATMENT OF POSTTRAUMATIC DIRECT CAROTID-CAVERNOUS FISTULA (DCCF) WITH DETACHABLE BALLOONS (DB) IS ASSOCIATED WITH RELATIVELY LOW COMPLETE OCCLUSION RATES (COMPLETE SEALING OF FISTULA WITH NO RESIDUAL CAVITY AND NO ENDOLEAKS). THIS STUDY AIMS TO COMPARE THE ANGIOGRAPHIC AND CLINICAL RESULTS OF TREATMENT WITH COVERED STENTS WITH THE RESULTS OF TREATMENT WITH DB. METHOD: THIRTY-FOUR PATIENTS WITH POSTTRAUMATIC DCCF WERE SELECTED FOR TREATMENT WITH NON-ABBOTT DB (N = 19, GROUP A) OR JOSTENT GRAFTMASTER COVERED STENTS (N = 15, GROUP B). DATA ON THE TECHNICAL SUCCESS, DURATION OF INITIAL PROCEDURE AND HOSPITAL STAY, INITIAL AND FINAL ANGIOGRAPHIC RESULTS, MORTALITY, MORBIDITY AND FINAL CLINICAL OUTCOMES WERE COLLECTED AND ANALYZED WITHIN 12 MONTHS, WITH POST-PROCEDURAL FOLLOW-UPS PERFORMED AT 1, 3, 6, AND 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171457 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R CONCOMITANT MEDICAL DEVICES