BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2770487 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06231
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: HT FLOPPY II; GUIDE CATHETER: 6F; SHEATH: 6F. INCORRECT PREP. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE STENT DISLODGEMENT WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THAT PRIOR TO USING THE MULTI-LINK 8 OR MULTI-LINK 8 LL CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. INSPECTION OF THE STENT IN THIS CASE WOULD HAVE IDENTIFIED THE STENT DISLODGEMENT PRIOR TO INSERTING INTO THE PATIENT; HOWEVER, DID NOT CONTRIBUTE TO THE REPORTED STENT DISLODGEMENT AS IT WAS POSSIBLY DUE TO HANDLING DURING SHEATH REMOVAL. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. THE PROTECTIVE SHEATH AND STYLET WERE REMOVED FROM A 4.0X18 RX MULTI-LINK 8 STENT SYSTEM. THE 4.0X18 RX MULTI-LINK 8 STENT SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND AFTER X-RAY SCREENING IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE 4.0X18 RX MULTI-LINK 8 STENT SYSTEM WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE STENT WAS CONFIRMED TO NOT BE ON THE BALLOON. REPORTEDLY, THE STENT WAS FOUND DISLODGED AND STUCK ON THE STYLET. A NEW SAME SIZE MULTI-LINK 8 STENT SYSTEM WAS IMPLANTED AND THE PATIENT HAD A SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2033041

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR CONCOMITANT MEDICAL DEVICES