BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2872050 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07886
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    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. (B)(4): FAILURE TO FOLLOW STEPS/INSTRUCTIONS. 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 MULTI-LINK 8 INSTRUCTIONS FOR USE STATES THAT PRIOR TO USING THIS DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE DISPENSER 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 LESION LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 75% STENOSED, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATATION WAS PERFORMED, THE MULTI-LINK 8 WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED; HOWEVER, AS NO STENT IMPLANT COULD BE VISUALIZED ON ANGIOGRAPHY, FURTHER INVESTIGATION REVEALED THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH. A NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. 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 2072741

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SIONGUIDE CATH: ACCESS