BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2853382 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07598
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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. 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 DURING A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION IN THE MID RIGHT CORONARY, A PERFORATION OCCURRED WITH A NON-ABBOTT BALLOON. THE 3.0 X 26 GRAFTMASTER WAS ADVANCED FOR TREATMENT, BUT MET RESISTANCE WITH THE 7F GUIDING CATHETER, AND BECAME STUCK 2/3 OF THE WAY IN. THE GUIDING CATHETER AND THE GRAFTMASTER WERE REMOVED AS A UNIT. AN 8F GUIDING CATHETER WAS THEN USED, BUT COULD NOT BE SEATED IN THE VESSEL. PERICARDIOCENTESIS PERFORMED AND THE PATIENT WAS STABILIZED; HOWEVER, THE PERFORATION WAS STILL LEAKING. THE PATIENT IS NOW STABLE, AND NO FURTHER TREATMENT HAS BEEN SCHEDULED. THE PHYSICIAN COMMENTED THAT THE GUIDING CATHETER MAY HAVE BEEN KINKED, CAUSING THE RESISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 723407

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention GUIDE CATH: 7 FR