BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1001945 · Received February 20, 2008

    Report

    Report Number
    2024168-2008-00123
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    July 9, 2007
    Report Date
    January 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THERE WERE THREE KINKS IN THE HYPOTUBE SHAFT 15.5 CM, 37.5 CM AND 83 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED SDS. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. HISTORICAL DATA SUGGESTS THAT STENT DISLODGEMENT MAY BE CAUSED BY, BUT NOT LIMITED TO, IMPROPER PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. IN THIS CASE, WITH THE INFO PROVIDED, THE TWO IMPLANTED STENTS FROM A PREVIOUS PROCEDURE LIKELY CONTRIBUTED TO THE DIFFICULTY TO CROSS AND THE STENT DISLODGEMENT. THE ANALYSIS OF THE SDS NOTED CRIMP MARKS VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT DISLODGEMENT/STENT MOVEMENT CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. IN ADDITION, THREE KINKS WERE NOTED IN THE HYPOTUBE, WHICH WERE NOT REPORTED IN THE INCIDENT AND MAY HAVE OCCURRED DURING THE PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED INABILITY TO CROSS OR STENT DISLODGEMENT. THE MFG LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORT ISSUED FOR THIS LOT THAT WERE RELATED TO THE REPORTED DISLODGED STENT. THE REPORTED DEVICE ISSUE APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT COMPRESSED AGAINST AN IMPLANTED STENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 2.5 X 12 MM MINI VISION STENT WAS BEING ADVANCED THROUGH TWO STENTS THAT WERE DEPLOYED IN THE DESCEND ANTERIOR ARTERY DURING ANOTHER PROCEDURE. THE TWO IMPLANTED STENTS FORMED AN ANGLE AND WHEN THE MINI VISION STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED THROUGH THE DEPLOYED STENTS THE MINI VISION STENT IMPLANT BECAME STUCK ON THE STRUTS OF ONE OF THE DEPLOYED STENTS. THE MINI VISION SDS WAS REMOVED FROM THE PATIENT, AND UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS BALLOON. THE STENT REMAINED IN THE PATIENT. THE GUIDE WIRE WAS STILL IN PLACE. SO A NON COMPLIANT BALLOON WAS USED TO CAPTURE THE STENT AND COMPRESS IT AGAINST ONE OF THE DEPLOYED STENTS. 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 7051031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention| S