BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2033348 · Received March 30, 2011

    Report

    Report Number
    2024168-2011-02157
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    May 4, 2009
    Report Date
    May 5, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. ALTHOUGH THE GRAFTMASTER WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE AIDED THE INVESTIGATION, THERE WAS NO NOTE OF ANY DAMAGE OBSERVED TO THE STENT DELIVERY SYSTEM (SDS) OR STENT IMPLANT PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, OR ACCESSORY DEVICE SUPPORT. IN THIS CASE, THE LESION WAS 99% STENOSED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. OVERALL, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER DAMAGE, STENT DAMAGE AND PROPER STENT PLACEMENT. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PROPER GUIDING CATHETER AND GUIDE WIRE MOVEMENT. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AN ACUTE MYOCARDIAL INFARCTION (MI) PATIENT. A MID LEFT ANTERIOR DESCENDING PERFORATION OCCURRED DURING THE USE OF A NON-ABBOTT BALLOON IN A 99% STENOSED VESSEL. THE GRAFTMASTER WAS UNABLE TO CROSS, DESPITE PROLONGED EFFORTS, AND WAS PLACED PROXIMAL TO THE PERFORATION. IT SIGNIFICANTLY REDUCED THE PERFORATION, AND NO FURTHER TREATMENT WAS ADMINISTERED FOR THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 505762

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other