BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3071064 · Received April 22, 2013

    Report

    Report Number
    2024168-2013-02475
    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 JUNE 2007 AND SEPTEMBER 2011, 15 PATIENTS (9 MALE) UNDERWENT TREATMENT FOR AN EXISTING POSTTRAUMATIC DIRECT CAROTID-CAVERNOUS FISTULA (DCCF) OF THE INTERNAL CAROTID ARTERY, EACH USING AN UNSPECIFIED JOSTENT GRAFTMASTER RX COVERED STENT. ONE PATIENT WITH ONE IMPLANTED JOSTENT GRAFTMASTER RX EXPERIENCED A TRANSIENT NEUROLOGIC DEFICIT DUE TO A PARENT ARTERY VASOSPASM; THE PATIENT WAS TREATED VIA INFUSION OF DILUTE PAPAVERINE HYDROCHLORIDE THROUGH THE GUIDING CATHETER AND THE SYMPTOMS RESOLVED. THERE WAS NO WORSENING OF THE PRELIMINARY CLINICAL PRESENTATION, NO OCCURRENCE OF ISCHEMIA OR REBLEEDING IN ANY PATIENT, AND NO DEATHS OCCURRED DURING THE STUDY PERIOD. NO ADDITIONAL INFORMATION WAS NOTED. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: BOSTON SCIENTIFIC TRANSEND 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, IT WAS NOTED THAT THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE REPORT: BY THE 3-MONTH FOLLOW-UP, SPONTANEOUS ENDOLEAK RESOLUTION AND DCCF OBLITERATION WITH INTERNAL CAROTID ARTERY RECONSTRUCTION HAD OCCURRED. NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172493 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R| S