BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3180580 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03834
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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. 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 THE PROCEDURE IN THE MID RIGHT CORONARY ARTERY FOR TREATMENT OF A PERFORATION, A 4.0X19 OTW GRAFTMASTER STENT WAS DEPLOYED AT 18 ATMOSPHERES. THE PERFORATION WAS NOT COMPLETELY SEALED. THE PERFORATION DID NOT SEAL ON ITS OWN AND AFTER 24 HOURS THE PATIENT WAS BROUGHT BACK TO THE CATH LAB THE FOLLOWING DAY AND A SECOND GRAFTMASTER WAS DEPLOYED SEALING THE PERFORATION. REPORTEDLY, THE EASE OF HANDLING FOR GRAFTMASTER STENT DELIVERY SYSTEM WAS POOR. THERE WAS NO REPORTED ADVERSE PATIENT SEQULEA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280408 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 725222

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R