BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 1962195 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00333
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. GUIDE WIRE: GALEO; INFLATION: MEDTRONICS; GUIDE CATH: CORDIS XB3. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS A KNOWN ADVERSE EVENT LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU). DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A CALCIFIED, TORTUOUS LESION OF THE MID CIRCUMFLEX ARTERY, THE 3.5 X 15 MM ZETA WAS DEPLOYED; HOWEVER, A DISSECTION WAS NOTED. A SECOND 3.5 X 13 MM ZETA WAS USED IN THE PROCEDURE AS TREATMENT. THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0020141

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention