BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3964897 · Received July 29, 2014

    Report

    Report Number
    2024168-2014-04844
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION- DEVICE STATUS CHANGED FROM DISCARDED TO RETURNED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED KINK AND SHAFT SEPARATION WERE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - USE AFTER DAMAGE; NO PRE-DILATATION. THE 2.5 X 12 MM RX MINI VISION REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - DEVICE DISCARDED. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IT SHOULD BE NOTED THAT THE CORONARY STENT SYSTEM, MULTI-LINK VISION, RX AND OTW INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY) CATHETER. ADDITIONALLY, THE IFU STATES: PRIOR TO USING THE MULTI-LINK MINI VISION RX OR MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. DO NOT USE IF ANY DEFECTS ARE NOTED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE CIRCUMFLEX WITH MODERATE CALCIFICATION, A 2.5X12 MM RX MINI VISION CORONARY STENT SYSTEM WAS ADVANCED VIA DIRECT STENTING BUT COULD NOT CROSS THE LESION DUE TO THE PATIENT ANATOMY AND THE PROXIMAL SHAFT KINKED. A 2.75X12 MM RX VISION CORONARY SYSTEM SYSTEM WAS ADVANCED VIA DIRECT STENTING BUT THE SAME OCCURRED, THE STENT SYSTEM COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THE PROXIMAL SHAFT KINKED. NO FORCE WAS APPLIED WHEN RESISTANCE WAS MET DURING ADVANCEMENT. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE KINKS FROM BOTH OF THE PROXIMAL SHAFTS WHILE THE STENT SYSTEMS WERE IN THE PATIENT ANATOMY WHICH CAUSED THE PROXIMAL SHAFTS OF BOTH STENT SYSTEMS TO SEPARATE. BOTH STENT SYSTEMS WERE WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE. AN UNKNOWN DRUG ELUTING STENT WAS IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442325 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 4020641

    Patients

    Seq Age Sex Outcome Treatment
    1