BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1954891 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00196
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. THE 3.0 X 28 MM PROMUS ((B)(4)), IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED GRAFTMASTER STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE ENTIRE LENGTH OF THE SHAFT, WHICH IS CONSISTENT WITH THE SDS ADVANCED IN THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE PROXIMAL BALLOON TAPER AND SHOULDER WERE BUNCHED. THE DISTAL EDGE OF THE TIP WAS JAGGED. THERE WAS A BUMP ON THE TIP, 1.5 MM PROXIMAL TO THE DISTAL EDGE. 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. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ADDITIONALLY, THE BALLOON BUNCHING AND DAMAGED TIP LIKELY OCCURRED DURING ADVANCEMENT IN THE ANATOMY IF RESISTANCE WAS ENCOUNTERED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERFORATION OCCURRED DURING DEPLOYMENT OF A PROMUS STENT. NO PRE-DILATATION WAS PERFORMED. AN ATTEMPT WAS MADE TO SEAL THE PERFORATION WITH THE INFLATION OF A BALLOON CATHETER; HOWEVER, THIS WAS NOT SUCCESSFUL. THE 3.0 X 16 GRAFTMASTER WAS SELECTED TO SEAL THE PERFORATION; HOWEVER, THE STENT DELIVERY SYSTEM FAILED TO CROSS, WHICH RESULTED IN THE TIP OF THE DEVICE BECOMING KINKED. A SECOND GRAFTMASTER STENT WAS SELECTED TO TREAT THE PERFORATION, WHICH WAS ABLE TO BE USED SUCCESSFULLY. THE PATIENT WAS DISCHARGED TWO DAYS LATER IN STABLE CONDITION. 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 642222

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention STENT: 3.0 X 28 MM PROMUS ((B)(4))