BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2141785 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04515
    Event Type
    Death
    Date Received
    June 27, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVALUATION. SUBSEQUENT INFORMATION WAS RECEIVED FROM THE ACCOUNT WHICH STATED THE LOT NUMBER COULD NOT BE IDENTIFIED AND THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY (TORTUOSITY OR CALCIFICATION), PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION, ACCESSORY DEVICE SUPPORT, OR INTERACTION WITH ACCESSORY DEVICES OR PREVIOUSLY DEPLOYED DEVICES. THE PATIENT ANATOMY WAS MODERATELY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. IT WAS REPORTED THE PATIENT DIED 20 HOURS POST PROCEDURE. HEMORRHAGE AND DEATH ARE LISTED AS OBSERVED OR POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CORONARY STENTING IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU). DUE TO THE INHERENTLY EMERGENT AND SERIOUS USE OF THE GRAFTMASTER DEVICE, IT IS POSSIBLE THAT THE PERFORATION ITSELF AND/OR THE INABILITY TO TREAT THE PERFORATION MAY HAVE CONTRIBUTED TO THE REPORTED CASCADING PATIENT EFFECTS THAT ULTIMATELY LED TO THE PATIENT DEATH. THE DEVICE WAS NOT RETURNED FOR EVALUATION; WITHOUT THE RETURN DEVICE A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED EVENT, THE PATIENT EFFECTS OR THEIR RELATIONSHIP TO THE DEVICE, IF ANY. BASED ON THE INFORMATION PROVIDED, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LOT NUMBER IS UNKNOWN BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILED, INFORMATION WAS RECEIVED STATING THAT POST A NON-ABBOTT STENT DEPLOYMENT A PERFORATION WAS NOTED AT THE DISTAL EDGE OF THE STENT. THE GRAFTMASTER WAS ATTEMPTED BUT COULD NOT CROSS THE PERFORATION. A SECOND NON-ABBOTT STENT WAS USED SUCCESSFULLY TO COVER THE PERFORATION. REPEAT ANGIOGRAM SHOWED A CONTAINED PERFORATION WITH NO INCREASE IN SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A TORTUOUS, CALCIFIED, LEFT ANTERIOR DESCENDING ARTERY A PERFORATION OCCURRED. THE GRAFTMASTER STENT DELIVERY SYSTEM WAS ATTEMPTED BUT COULD NOT CROSS THE LESION. IT WAS NOTED THAT THE PATIENT DID NOT DIE DURING THE PROCEDURE, HOWEVER, APPROXIMATELY 20 HOURS POST PROCEDURE THE PATIENT DIED FROM RESPIRATORY FAILURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death