BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2821652 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06994
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    April 21, 2012
    Report Date
    September 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    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. (B)(4) - STENT DELIVERY SYSTEM ADVANCEMENT USING EXCESSIVE FORCE THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED COLLAPSED TIP COULD NOT BE CONFIRMED. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE PROXIMAL SEAL WAS NOTED TO BE SEPARATED. THE SOFT TIP WAS ALSO FOUND TO BE SEPARATED BUT ADDITIONAL REPORTED INFORMATION CONFIRMED THAT THE SEPARATION OCCURRED DURING PACKAGING FOR RETURN ANALYSIS. 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 THIS 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 VISION INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. 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 DURING THE PROCEDURE IN THE HEAVILY CALCIFIED RAMUS ARTERY, AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE THE 2.75X28 RX VISION STENT SYSTEM THROUGH THE LESION. FORCE WAS APPLIED TO THE STENT SYSTEM DURING ADVANCEMENT. THE STENT SYSTEM WAS WITHDRAWN FROM THE ANATOMY AND THE TIP OF THE STENT SYSTEM WAS NOTED TO BE COLLAPSED. A 2.75X28 MULTI-LINK VISION STENT SYSTEM WAS USED TO TREAT THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE PROXIMAL SEAL AND THE SOFT TIP ARE SEPARATED. ADDITIONAL REPORTED INFORMATION INDICATES THAT INFORMATION PERTAINING TO THE SEPARATION OF THE PROXIMAL SEAL IS NOT AVAILABLE BECAUSE NEITHER THE TECHNICIAN OR THE PHYSICIAN NOTICED THE PROXIMAL SEAL SEPARATION. ADDITIONAL REPORTED INFORMATION PERTAINING TO THE SEPARATED SOFT TIP INDICATES THAT THE SEPARATION OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1092241

    Patients

    Seq Age Sex Outcome Treatment
    1