BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1163385 · Received September 10, 2008

    Report

    Report Number
    2024168-2008-00788
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 11, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - OTHER - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE LOOSE STENT. EVALUATION SUMMARY - QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE STENT IMPLANT, BALLOON, AND SHAFT. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS RETURNED ON THE STYLET. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS LOOSELY FOLDED. THERE WERE CRIMP MARS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE ORANGE PROTECTIVE SHEATH WAS RETURNED. THE TIP SEAL LENGTH WAS 1 MM. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE MEASUREMENTS MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS. ANALYSIS OF THE RETURNED SDS NOTED PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND THE BALLOON LOOSELY FOLDED WHICH SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE AND LIKELY INFLATED OR HAD SOME POSITIVE PRESSURE APPLIED. THERE WAS ALSO BLOOD NOTED IN THE GUIDE WIRE LUMEN. THIS SUGGESTS THAT THE SDS WAS AT LEAST LOADED ONTO THE GUIDE WIRE, WHICH IS INCONSISTENT WITH THE REPORTED INFORMATION OF THE ANOMALY BEING NOTICED WHEN THE PROTECTIVE SHEATH WAS TAKEN OFF THE STENT IMPLANT. THE STENT IMPLANT WAS RETURNED ON THE STYLET. FACTORS THAT CAN AFFECT LOOSE/DISLODGED STENT INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, INCORRECT SHEATH SIZING, FORCED SHEATH REMOVAL OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. ANALYSIS OF THE RETURNED DEVICE INDICATES PRESENCE OF CRIMP MARKS BETWEEN THE MARKERS OF THE LOOSELY FOLDED BALLOON, SUGGESTING THAT THE STENT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. THE LOOSELY FOLDED BALLOON COULD BE THE RESULT OF THE PHYSICIAN ATTEMPTING TO DEPLOY THE STENT BEFORE REALIZING THE STENT IMPLANT HAD DISLODGED, BUT IT COULD ALSO INDICATE THAT POSITIVE PRESSURE WAS APPLIED PRIOR TO USE. IF POSITIVE PRESSURE WAS APPLIED TO THE SYSTEM DURING PREPARATION, THIS MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS FOUND TO BE WITHIN SPECIFICATION. ALSO THE STENT OUTER DIAMETERS WERE WITHIN MANUFACTURING CRITERIA. BASED ON THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED COMPLAINT OF LOOSE STENT CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST THAT MATERIALS OR WORKMANSHIP MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: LOOSE STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE STENT. IT WAS REPORTED THAT WHEN THE SHEATH WAS REMOVED, THE STENT WAS ALREADY LOOSE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8052331

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR