BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3114651 · Received May 15, 2013

    Report

    Report Number
    2024168-2013-03081
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 20, 2005
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 3.0 X 26 JOSTENT GRAFTMASTER STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. EVENT DESCRIPTION CONTINUED: FOR THE PROXIMAL PLACED STENT THE FOLLOWING POST-STENT IMPLANTATION ANGIOGRAMS REVEALED THE FOLLOWING PERCENTAGE STENOSIS AT THE FOLLOWING TIME INTERVALS: 3 MONTHS: 29%; 6 MONTHS: 31.2%; 10 MONTHS: 32.9%; 16 MONTHS: 31%; 65 MONTHS: 36.5%. FOR THE DISTAL PLACED STENT THE FOLLOWING POST-STENT IMPLANTATION ANGIOGRAMS REVEALED THE FOLLOWING PERCENTAGE STENOSIS AT THE FOLLOWING TIME INTERVALS: 3 MONTHS: 27.6%; 6 MONTHS: 38.9%; 10 MONTHS: 42%; 16 MONTHS: 36%; 65 MONTHS: 37.4%. NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF EVENT ESTIMATED AS 3 MONTHS POST-STENT IMPLANTATION ((B)(6) 2005); TEST DATES ESTIMATED; DATE OF IMPLANT ESTIMATED ((B)(6) 2004); ESTIMATED THERAPY DATE; ARTICLE REVIEWED (B)(4) 2013. ARTICLE: (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:713-716): LONG-TERM OUTCOME OF TRANSCATHETER POLYTETRAFLUOROETHYLENE-COVERED STENT IMPLANTATION IN A GIANT CORONARY ANEURYSM OF A CHILD WITH KAWASAKI DISEASE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF STENOSIS IS LISTED IN THE RX GRAFTMASTER INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION: (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:713-716): "LONG-TERM OUTCOME OF TRANSCATHETER POLYTETRAFLUOROETHYLENE-COVERED STENT IMPLANTATION IN A GIANT CORONARY ANEURYSM OF A CHILD WITH KAWASAKI DISEASE". IT WAS REPORTED THAT AN 8-YEAR OLD MALE PRESENTED WITH A GIANT RIGHT CORONARY ARTERY (RCA) ANEURYSM AND AN ANEURYSM IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY DUE TO KAWASAKI DISEASE. THE GIANT 11MM DIAMETER X 16MM LONG ANEURYSM IN THE RCA WAS TREATED VIA IMPLANTATION OF A 3.0X26 JOSTENT GRAFTMASTER COVERED STENT SYSTEM IN THE 90% STENOSED NON-TORTUOUS PROXIMAL RCA AND IMPLANTATION OF A 3.5X16 JOSTENT GRAFTMASTER IN THE 50% STENOSED NON-TORTUOUS DISTAL RCA, OVERLAPPING THE 3.0X26 JOSTENT GRAFTMASTER. IMMEDIATE CORONARY ANGIOGRAM OF THE 3.0X16 STENT CONFIRMED IMPROVED STENOSIS RESOLUTION AND BLOOD FLOW PATTERN. THE PATIENT WAS DISCHARGED IN GOOD CONDITION 11 DAYS POST-PROCEDURE. A FOLLOW-UP ANGIOGRAM PERFORMED AT 3 MONTHS POST STENT IMPLANTATION REVEALED IN-STENT RESTENOSIS OF BOTH STENT EDGES, WHICH PROGRESSED UNTIL 10 MONTHS POST STENT IMPLANTATION; AFTER 10 MONTHS THE PROGRESSION OF THE IN-STENT RESTENOSIS HAD STOPPED. A FOLLOW-UP ANGIOGRAM PERFORMED 5.5 YEARS AFTER STENT IMPLANTATION SHOWED WELL MAINTAINED PATENCY DESPITE MILD RESTENOSIS AT THE EDGES OF THE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215484 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other