BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1003724 · Received February 20, 2008

    Report

    Report Number
    2024168-2008-00125
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    November 20, 2007
    Report Date
    January 21, 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

    A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS RETURNED, BUT NOT ON THE BALLOON. THE STENT IMPLANT WAS FLATTENED FROM THE DISTAL END TO THE PROXIMAL END. THE PROXIMAL END OF THE STENT IMPLANT WAS FLARED. THE BALLOON HAD LOOSE FOLDS AND WAS PARTIALLY FILLED WITH CONTRAST. THERE WERE FAINT CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THE PROTECTIVE SHEATH AND STYLET WERE RETURNED. THERE WERE NUMEROUS KINKS IN THE SHAFT DUE TO THE WAY IT WAS ROLLED UP WHEN RETURNED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. DUE TO THE DAMAGED STENT IMPLANT, THE OUTER DIAMETERS COULD NOT BE MEASURED. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED WITH A PIN GAUGE AND MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED SDS. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. NO DAMAGE WAS REPORTED AS BEING NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE; HOWEVER, ANALYSIS OF THE SDS NOTED THAT THE STENT IMPLANT WAS DAMAGED AND DISLODGED FROM THE BALLOON. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, WHICH SUGGESTS THAT THE SDS HAD BEEN PREPARED FOR USE AND INFLATED. FAINT CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IT IS EXPECTED THAT THE CRIMP MARKS WOULD BECOME LESS DEFINED AFTER INFLATING THE BALLOON. POTENTIAL CAUSES OF STENT DISLODGEMENT ARE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. THE STENT IMPLANT WAS RETURNED WITH FLARED STRUTS ON THE PROXIMAL END. THE DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING REACTION OF THE DEVICE. THE INNER DIAMETER DIMENSION OF THE PROTECTIVE SHEATH MET MANUFACTURING CRITERIA; HOWEVER, THE STENT OUTER DIAMETER DIMENSION COULD NOT BE MEASURED DUE TO STENT DAMAGE. THE STENT WAS FLATTENED ON THE ENTIRE LENGTH, IN ADDITION TO NUMEROUS KINKS THROUGHOUT THE SHAFT. THIS DAMAGE LIKELY OCCURRED DURING THE PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THE MANUFACTURING LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT THAT WERE RELATED TO THE REPORTED DISLODGED STENT. UNFORTUNATELY, WITH THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED INABILITY TO CROSS, HOWEVER, THERE DOES NOT APPEAR TO BE A PRODUCT QUALITY ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 3.5 X 12 MM RX VISION STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE WHICH REVEALED THAT THE STENT WAS DISLODGED AND LOCATED ON THE STYLET. IT IS UNKNOWN WHEN THE STENT DISLODGED. THE SDS BALLOON APPEARED TO HAVE BEEN INFLATED. THE ANALYSIS ALSO REVEALED THAT THERE WAS NO BLOOD PRESENT ON, OR IN THE SDS, OR THE DISLODGED STENT IMPLANT. THEREFORE, IT APPEARS THAT THE DEVICE NEVER ENTERED INTO THE PATIENT'S ANATOMY. THE FACT THAT THE SDS BALLOON WAS LOOSELY FOLDED AND CONTRAST WAS VISIBLE, SUGGESTS THE SDS HAS BEEN PREPARED FOR USE AND INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR - CARDIAC THERAPIES NA 7051431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK