BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3150806 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03551
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. 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. HEMORRHAGE IS LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT PROCEDURES. 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. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE STATES THAT IF THE PHYSICIAN ENCOUNTERS RESISTANCE TO THE DELIVERY SYSTEM PRIOR TO EXITING THE GUIDING CATHETER, DO NOT FORCE PASSAGE. RESISTANCE MAY INDICATE A PROBLEM AND MAY RESULT IN DAMAGE TO THE STENT GRAFT IF IT IS FORCED. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES: DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT GRAFT BACK THROUGH THE GUIDING CATHETER; DISLODGEMENT OF THE STENT GRAFT FROM THE BALLOON MAY OCCUR. IT IS LIKELY THAT THE ADVANCEMENT AGAINST RESISTANCE AND RE-INSERTION OF THE GRAFTMASTER CONTRIBUTED TO THE STENT DISLODGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR TREATMENT OF A PERFORATION IN THE DISTAL LEFT CIRCUMFLEX ARTERY, USING A STANDARD SINGLE GUIDE WIRE TECHNIQUE, AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE A 3.0X12 GRAFTMASTER STENT DELIVERY SYSTEM (SDS) THROUGH AN ANGLE FROM THE LEFT MAIN ARTERY INTO THE PROXIMAL LEFT CIRCUMFLEX ARTERY. THEREFORE, THE SDS WAS BACKED OUT AND THE PERFORATION WAS RE-TAMPONADED WITH LONG BALLOON LOW PRESSURE OCCLUSION. BRISK CONTRAST EXTRAVASATION CONTINUED SO A SECOND MORE AGGRESSIVE ATTEMPT WAS MADE WITH A BUDDY WIRE TO ADVANCE THE GRAFTMASTER SDS WITH LIMITED SUCCESS AS THE SDS WENT PARTIALLY INTO THE LEFT CIRCUMFLEX BUT WOULD NOT ADVANCE OR WITHDRAW. AN ATTEMPT WAS MADE TO BRING THE GUIDE CATHETER INTO THE LEFT MAIN TO BETTER ALIGN WITH SDS RETRACTION BUT THE STENT DISLODGED AND WAS SUBSEQUENTLY SNARED SUCCESSFULLY. ADDITIONAL PROLONGED BALLOON TAMPONADE OVER 8 HOURS RESULTED IN SLOWING OF CONTRAST EXTRAVASATION BUT NOT COMPLETE TAMPONADE. FINALLY THE DECISION WAS MADE TO WATCH FOR TAMPONADE PHYSIOLOGY AND PERFORM PERICARDIAL TAP; HOWEVER, THE PATIENT REMAINED STABLE OVER LONG OBSERVATION AND WAS TRANSFERRED TO THE CORONARY CARE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250928 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 723409

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R