BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3143353 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03464
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. REVIEW OF THE LABELS ATTACHED TO THE DEVICE HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND LABEL INDICATED AN EXPIRATION DATE (USE BY DATE) OF 30-APRIL-2012 AND THE IMPLANT PROCEDURE DATE IS (B)(6) 2013 WHICH IS APPROXIMATELY 12 MONTHS POST EXPIRATION. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE STATES THAT IT IS NOT RECOMMENDED THAT THE PRODUCT BE USED AFTER THE USE BEFORE DATE. ADDITIONALLY, BASED ON NEW INFORMATION RECEIVED FROM THE SITE STATING THE PATIENT DEATH WAS NOT RELATED TO THE GRAFTMASTER DEVICES AND THE PATIENT PRESENTED WITH THE NEED FOR CARDIOPULMONARY RESUSCITATION (CPR), WHICH HAD BEEN INITIATED PRIOR TO THE INSERTION OF THE GRAFTMASTER OTW DEVICES, AND THE JOSTENT GRAFTMASTERS HAD A MODERATE RATING FOR EASE OF USE DUE TO BEING USED WHILE CPR WAS SIMULTANEOUSLY BEING ADMINISTERED, THIS EVENT WOULD NOT HAVE BEEN REPORTABLE. HOWEVER, THE INITIAL MDR HAS ALREADY BEEN FILED; THEREFORE, THIS EVENT MUST REMAIN A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE FIRST JOSTENT GRAFTMASTER 3.5 X 12 MM MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. 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) - USE AFTER EXPIRATION. 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. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER INSTRUCTIONS FOR USE STATES THAT IT IS NOT RECOMMENDED THAT THE PRODUCT BE USED AFTER THE USE BEFORE DATE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT CARDIOPULMONARY RESUSCITATION (CPR) HAD BEEN INITIATED PRIOR TO THE INSERTION OF THE GRAFTMASTER OTW DEVICES, THAT THE JOSTENT GRAFTMASTERS HAD A MODERATE RATING FOR EASE OF USE DUE TO BEING USED WHILE CPR WAS BEING ADMINISTERED, AND THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM THE PRESENTING ACUTE PERFORATION OF SAPHENOUS VEIN GRAFT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF TWO 3.5X12 OTW JOSTENT GRAFTMASTER COVERED STENTS IN A SAPHENOUS VEIN GRAFT TO TREAT AN EXISTING FREE PERFORATION, THOUGH THE GRAFTMASTERS SEALED THE PERFORATIONS AND THERE WERE REPORTEDLY NO ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS CAUSED BY THE GRAFTMASTERS, THE PATIENT EXPIRED FOR A REASON REPORTEDLY UNRELATED TO THE GRAFTMASTER DEVICES. EASE OF USE OF THESE TWO DEVICES WAS RATED AS "MODERATE". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244540 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 595668

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O JOSTENT GRAFTMASTER 3.5 X 12 MM