BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3013598 · Received March 20, 2013

    Report

    Report Number
    2024168-2013-01600
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: RUNTHROUGHS; GUIDE CATH: HEARTRAIL. 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY THE LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION, AND 90% STENOSIS. A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE LESION USING A RADIAL APPROACH AND WHILE MANIPULATING THE GUIDE WIRE, A PERFORATION OCCURRED IN THE DISTAL CIRCUMFLEX. AN ATTEMPT WAS MADE TO ACHIEVE HEMOSTASIS USING A 3.0MM NON-ABBOTT BALLOON CATHETER BUT IN VAIN. THUS, THE GRAFTMASTER WAS ADVANCED TO THE LESION BUT FAILED TO CROSS. DURING THE ATTEMPTS TO CROSS, THE TIP GOT KINKED. THUS, THE GRAFTMASTER WAS REMOVED OUT OF THE ANATOMY (THE STENT GRAFT WAS NOT IMPLANTED). HEMOSTASIS WAS FINALLY ACHIEVED BY INFLATING THE 3.0MM NON-ABBOTT BALLOON. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116315 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 721184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention