BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2176598 · Received July 26, 2011

    Report

    Report Number
    2024168-2011-05149
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VISION CHIPBOARD BOX FOUND IT WAS OPENED WITH AN EMPTY COIL DISPENSER INSIDE THE CHIPBOARD BOX. THERE WAS A SMALL AMOUNT OF CONTRAST NOTED ON ONE OF THE TUBES OF THE COIL DISPENSER, WHICH IS CONSISTENT WITH HANDLING DURING THE PROCEDURE. THE CHIPBOARD BOX WAS TORN OPEN AT THE FLAP ON THE TOP OF THE BOX. THE LABEL DESCRIPTION ON THE CHIPBOARD BOX LISTED A 3.50X15MM RX VISION STENT DELIVERY SYSTEM (SDS) WITH PART NUMBER 1007849-15 AND LOT NUMBER 0102841. THE TYVEK POUCH WAS RETURNED OPENED ON THE TOP AND RIGHT SIDE OF THE VENDOR SEAL. THE POUCH WAS LABELED AS A 3.0X12MM RX VISION SDSWITH PART NUMBER 1007848-12 AND LOT NUMBER 1022341. THE HUB (SINGLE ARM) OF THE DEVICE WAS ALSO LABELED AS A 3.0X12MM RX VISION WITH LOT NUMBER 1022341, WHICH MATCHES THE LABEL ON THE POUCH. THIS CONFIRMS THE REPORTED COMPLAINT AS THE LABELING ON THE POUCH AND SDS DO NOT CORRESPOND WITH THE LABEL AFFIXED TO THE CHIPBOARD BOX. THE SDS WAS REMOVED FROM THE COIL DISPENSER AND THERE WAS NO BLOOD OR CONTRAST VISIBLE. THE ORANGE PROTECTIVE SHEATH WAS PLACED OVER THE BALLOON AND STENT IMPLANT WITH THE STYLET INSIDE THE TIP. THE SHEATH WAS REMOVED AND THE STENT WAS STATIONARY ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS. THE STENT WAS MEASURED AND WAS THE CORRECT LENGTH OF 12MM. THERE WAS A SLIGHT BEND NOTED IN THE HYPOTUBE, HOWEVER, THIS DAMAGE WAS NOT ORIGINALLY REPORTED AND LIKELY OCCURRED DURING THE PROCEDURE OR FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED COMPLAINT. FACTORS THAT CAN POTENTIALLY CONTRIBUTE TO A MISLABELING DISCREPANCY MAY INCLUDE, BUT ARE NOT LIMITED TO, MISLABELING DURING MANUFACTURING, A MIX-UP DURING REWORK, OR DUE TO A MIX-UP AT AN AFFILIATE, DISTRIBUTOR, OR THE ACCOUNT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY SIMILAR INCIDENTS WITH THESE LOTS. IN THIS CASE, THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING MANUFACTURING AND PACKAGING OF THE PRODUCTS AT ABBOTT VASCULAR. IT IS POSSIBLE THAT THE 3.0X12MM VISION POUCH/DEVICE WAS INADVERTENTLY PLACED IN A 3.50X15MM RX VISION CHIPBOARD BOX AT THE DISTRIBUTOR OR AT THE ACCOUNT, ALTHOUGH THIS CANNOT BE CONFIRMED. ALTHOUGH THE EXACT CAUSE FOR THE MISLABELING/MIX-UP CANNOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.5 X 15 VISION, LOT # 0102841 WAS SELECTED FOR USE; HOWEVER, WHEN THE BOX WAS OPENED, IT WAS OBSERVED THAT THE INNER POUCH SIZE WAS LABELED AS A 3.0 X 12 VISION, LOT # 1022341. THE INNER POUCH WAS OPENED AND THE HUB WAS ALSO LABELED AS A 3.0 X 12 VISION. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW 3.5 X 15 VISION WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0102841

    Patients

    Seq Age Sex Outcome Treatment
    1