BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2230118 · Received August 31, 2011

    Report

    Report Number
    2024168-2011-06057
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - REMOVED. CONCLUSIONS - REMOVED. THE RETURNED GOODS LAB ANALYSIS NOTED NO BLOOD AND THE BALLOON WAS TIGHTLY FOLDED, WHICH IS CONSISTENT WITH NOT BEING USED. THERE WAS CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION FOR USE. THIS IS INCONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT DELIVERY SYSTEM (SDS) WAS NOT CONNECTED TO AN INFLATION DEVICE OR PREPARED FOR USE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT CONCERNING THE PRESENCE OF CONTRAST, BUT TO DATE, NO ADDITIONAL INFORMATION WAS RECEIVED. THE UNDAMAGED STENT IMPLANT WAS FOUND DISLODGED FROM THE BALLOON AND WAS LOCATED OVER THE DISTAL BALLOON TAPER; THEREFORE, CONFIRMING THE INCIDENT. HOWEVER, THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT IMPLANT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURING. THE PHYSICIAN PLACED THE STENT IMPLANT BACK ONTO THE BALLOON AFTER THE DISLODGEMENT, WHICH EXPLAINS WHY THE STENT IMPLANT WAS NOT BETWEEN THE MARKERS. THE STENT IMPLANT OUTER DIAMETERS AND THE INNER DIAMETER OF THE PROTECTIVE SHEATH BOTH MET MANUFACTURING SPECIFICATION. IT IS POSSIBLE THAT POSITIVE PRESSURE WAS INADVERTENTLY APPLIED DURING PREPARATION FOR USE. IT IS ALSO POSSIBLE THAT THE PHYSICIAN INADVERTENTLY APPLIED PRESSURE WHILE INSPECTING THE STENT IMPLANT. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE STENT IMPLANT CAME OFF THE BALLOON WITH MINIMAL FORCE IN THE HANDS OF THE PHYSICIAN. IT SHOULD BE NOTED THAT THE MULTI-LINK VISION INSTRUCTIONS FOR USE STATES: SPECIAL CARE MUST BE TAKEN NOT TO HANDLE OR IN ANY WAY DISRUPT THE STENT ON THE BALLOON. DO NOT MANIPULATE THE STENT WITH YOUR FINGERS, AS THIS ACTION MAY LOOSEN THE STENT FROM THE DELIVERY BALLOON. IT UNKNOWN IF THE REPORTED USE ERROR DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT.

    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: POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IT IS POSSIBLE THAT THE PHYSICIAN INADVERTENTLY APPLIED PRESSURE WHILE INSPECTING THE STENT IMPLANT. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL SDS ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT/SECURITY. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT PLACEMENT/SECURITY AND STENT DEPLOYMENT. THE RETURNED GOODS LAB ANALYSIS NOTED NO BLOOD AND THE BALLOON WAS TIGHTLY FOLDED, WHICH IS CONSISTENT WITH THE DEVICE NOT BEING USED. THE UNDAMAGED STENT IMPLANT WAS FOUND DISLODGED FROM THE BALLOON AND WAS LOCATED OVER THE DISTAL BALLOON TAPER; THEREFORE, CONFIRMING THE INCIDENT. HOWEVER, THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT IMPLANT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURING. THE STENT IMPLANT OUTER DIAMETERS AND THE INNER DIAMETER OF THE PROTECTIVE SHEATH BOTH MET MANUFACTURING SPECIFICATION. IT WAS REPORTED THAT THE STENT IMPLANT CAME OFF THE BALLOON WITH MINIMAL FORCE IN THE HANDS OF THE PHYSICIAN. IT SHOULD BE NOTED THAT THE MULTI-LINK VISION INSTRUCTIONS FOR USE STATES: SPECIAL CARE MUST BE TAKEN NOT TO HANDLE OR IN ANY WAY DISRUPT THE STENT ON THE BALLOON. DO NOT MANIPULATE THE STENT WITH YOUR FINGERS, AS THIS ACTION MAY LOOSEN THE STENT FROM THE DELIVERY BALLOON. IT APPEARS THAT THE USE ERROR LIKELY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT IMPLANT ON A 3.5 X 18MM VISION STENT DELIVERY SYSTEM (SDS) DISLODGED FROM THE BALLOON IN THE HANDS OF THE PHYSICIAN. THE PHYSICIAN WAS INSPECTING THE DEVICE PRIOR TO USE AND THE STENT CAME OFF THE BALLOON WITH MINIMAL FORCE, AND IT WAS STATED THAT THE PHYSICIAN FELT IT WAS A LITTLE LOOSE AND CAME OFF WITH VERY EASILY. LIKEWISE, THE STENT IMPLANT WAS ABLE TO BE PLACED BACK ONTO THE BALLOON WITH VERY LITTLE FORCE REQUIRED. THE DEVICE WAS NOT USED ON THE PATIENT AND ANOTHER DEVICE 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 1052041

    Patients

    Seq Age Sex Outcome Treatment
    1