BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 1920310 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02669
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND DELAY IN TREATMENT ARE ADDRESSED IN THE PRODUCT RISK ASSESSMENT AS POTENTIAL PROCEDURE COMPLICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE UNK VOYAGERS AND GRAFTMASTERS ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE CALCIFIED CIRCUMFLEX ARTERY AN UNK VOYAGER BALLOON RUPTURED AT 8 ATMOSPHERES AND A PERFORATION OCCURRED. VENTRICULAR TACHYCARDIA OCCURRED AND THE PATIENT WAS INTUBATED. AN UNK GRAFTMASTER COULD NOT BE ADVANCED TO TREAT THE LESION. DURING GRAFTMASTER REMOVAL THE GUIDE CATHETER CAME OUT OF THE LEFT MAIN OSTIUM. THE GRAFTMASTER STENT DISLODGED FROM THE DELIVERY SYSTEM, FLOATING ON THE GUIDE WIRE. ALL DEVICES INCLUDING THE GUIDE WIRE WERE REMOVED; HOWEVER, THE DISLODGED STENT CAME OFF OF THE GUIDE WIRE IN THE PROFUNDA. STENT STILL REMAINS LOOSE IN THE PROFUNDA. AN UNK ABBOTT BARE METAL STENT (BMS) WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A SECOND UNK GRAFTMASTER WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. A THIRD UNK GRAFTMASTER WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. AN UNK 3X5 VOYAGER BALLOON WAS INFLATED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A 4.0 NC MERLIN WAS INFLATED TO 20 ATMOSPHERES AND SUCCESSFULLY SEALED THE LESION. PERICARDIOCENTESIS WAS PERFORMED WITH 500 CC FLUID RETRIEVED. THE PATIENT'S CONDITION IMPROVED AND HE WAS DISCHARGED ON (B)(6) 2010. THE DISLODGED GRAFTMASTER STENT REMAINS FLOATING IN THE LOWER EXTREMITY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 3.5X23 VISION, UNK VOYAGER, UNK GRAFTMASTER(#1)