BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2033356 · Received March 30, 2011

    Report

    Report Number
    2024168-2011-02156
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. FAILURE TO SEAL THE PERFORATION (THE REPORTED LEAK) MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, STENT GRAFT FOIL DAMAGE, PATIENT ANATOMICAL MORPHOLOGY, PRODUCT SIZE SELECTION, DEPLOYMENT TECHNIQUE (NON-CENTRAL POSITIONING OF STENT GRAFT OVER PERFORATION OR INADEQUATE OVERLAPPING), INTERFERENCE FROM PREVIOUSLY DEPLOYED DEVICES, OR GROWTH OF PERFORATION DURING DEPLOYMENT. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY INDICATE THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. IN THIS CASE, NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BOTH OF WHICH MAY HAVE AIDED THE INVESTIGATION. IT IS POSSIBLE THAT THE STENT DID NOT HAVE PROPER VESSEL WALL APPOSITION TO PROPERLY SEAL THE PERFORATION; HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED. THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEARS TO BE A SECONDARY EFFECT TO THE FAILURE TO SEAL AS ANOTHER GRAFTMASTER STENT WAS PLACED TO SUCCESSFULLY SEAL THE PERFORATION. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS (SDS) ARE 100% LEAK-TESTED AND VISUALLY INSPECTED FOR FOIL DAMAGE AND PROPER PLACEMENT ONLINE DURING THE MANUFACTURING PROCESS. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR FAILURE TO SEAL THE PERFORATION (LEAK) FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE TO SEAL (LEAK), THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TYPE II PERFORATION OCCURRED DURING THE USE OF A NON-ABBOTT DRUG ELUTING STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER DEPLOYMENT OF THE 3.5 X 12 MM GRAFTMASTER AT 8 ATMOSPHERES, THE PERFORATION WAS NOT COMPLETELY SEALED. A 4.0 X 19 MM GRAFTMASTER WAS PLACED, SUCCESSFULLY SEALING THE PERFORATION. THE PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT OVERNIGHT FOR MONITORING AND THEN TRANSFERRED TO THE UNIT. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2009. 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 532981

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention