BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1760550 · Received July 15, 2010

    Report

    Report Number
    2024168-2010-01400
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN AND ON THE STENT IMPLANT, BALLOON AND HYPOTUBE. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT IMPLANT DISLODGED FROM THE BALLOON AND WAS RETURNED. THE DISTAL END AND PROXIMAL END OF THE STENT IMPLANT WERE SLIGHTLY CRUSHED. THERE WERE STRETCHED STRUTS IN THE MIDDLE PORTION OF THE STENT IMPLANT. THERE WERE NO OTHER DAMAGES NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE NO KINKS OR DAMAGE NOTED TO THE TIP OR INNER MEMBER. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE ENTIRE LENGTH OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED, DUE TO THE DAMAGE NOTED. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS INSERTED INTO THE PATIENT AND SUGGESTS IT WAS PREPARED FOR USE BUT NOT INFLATED. THE INABILITY TO CROSS A LESION CAN BE THE RESULT OF, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. ANALYSIS OF THE RETURNED PRODUCT NOTED NO KINKS OR DAMAGE NOTED TO THE TIP OR INNER MEMBER AND THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, A FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IN THIS CASE, IT IS POSSIBLE THAT THERE MAY HAVE BEEN CHALLENGING ANATOMY CHARACTERISTICS THAT COULD HAVE CONTRIBUTED TO THE FAILURE TO CROSS THE LESION AND THE STENT MAY HAVE BEEN CAUGHT ON THE GUIDING CATHETER DURING RETRACTION THEN SUBSEQUENTLY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT; HOWEVER, THIS CANNOT BE CONFIRMED. IN THIS CASE, A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE DISLODGED STENT FROM THE PATIENT. THE CONDITION OF THE RETURNED STENT APPEARS TO BE FROM THE SNARING PROCEDURE TO RETRIEVE THE STENT. REPORTEDLY, THE LESION LOCATION WAS IN THE LEFT RENAL ARTERY. IT SHOULD BE NOTED THAT THE RX VISION INSTRUCTION FOR USE STATES "THE MULTI-LINK VISION RX AND THE MULTI-LINK VISION OTW CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER". IT IS UNKNOWN IF THE USE OF THE DEVICE IN THE LEFT RENAL ARTERY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS OR STENT DISLODGEMENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED, THE FAILURE TO CROSS APPEARS TO BE RELATED TO THE CIRCUMSTANCE OF THE PROCEDURE. THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. ALL STENT DELIVERY SYSTEMS (SDS) ARE INSPECTED FOR PROPER STENT PLACEMENT AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT MOVEMENT AND STENT DISLODGEMENT FORCE PRIOR TO RELEASE OF THE LOT.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT DISLODGEMENT REQUIRING INTERVENTION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE RX VISION WAS UNABLE TO CROSS THE LEFT RENAL ARTERY. UPON REMOVAL OF THE RX VISION FROM THE PATIENT, THE STENT DISLODGED FROM THE BALLOON DELIVERY SYSTEM AND WAS RETRIEVED WITH A SNARE DEVICE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR CLONMEL NA 0042041

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention STENT: 4.0 X 16 VERAFLEX