BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2231899 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06096
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE MIDDLEWEIGHT. GUIDE CATH: JR4. SHEATH: 6FR. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VISION STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, WHICH SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE AND LOADED ONTO A GUIDE WIRE AT SOME POINT. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE TWO STRUTS IN THE FIRST ROW AT THE PROXIMAL END OF THE STENT THAT WERE BENT, CONFIRMING THE REPORTED STENT DAMAGE. HOWEVER, AS THIS DAMAGE WAS NOT NOTED DURING INSPECTION PRIOR TO USE, THE STRUTS LIKELY BECAME BENT DURING OR AFTER THE PROCEDURE. THIS TYPE OF DAMAGE IS MOST CONSISTENT WITH AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR ROTATING HEMOSTATIC VALVE (RHV) DURING RETRACTION OF THE PRODUCT. THE ANALYSIS FURTHER REVEALED THAT THERE WAS BALLOON PEELING/SHREDDING AT THE PROXIMAL BALLOON SEAL. THERE WERE ALSO MULTIPLE BENDS IN THE HYPOTUBE, WHICH LIKELY OCCURRED FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS BENDS DO NOT APPEAR TO BE RELATED TO THE REPORTED COMPLAINT. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE AIDED THE INVESTIGATION. THEREFORE, FUNCTIONAL TESTING WAS PERFORMED USING NEW 6F GUIDING CATHETER, HOWEVER, THE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTY, AS THE SDS WAS ADVANCED THROUGH THE GUIDING CATHETER WITHOUT ANY RESISTANCE NOTED. MEASUREMENTS OF THE TIP LENGTH AND THE OUTER DIAMETER OF THE STENT AT THE DISTAL END AND IN THE MIDDLE WERE ALSO TAKEN, AND ALL DIMENSIONS MET MANUFACTURING CRITERIA. THE PROXIMAL END OF THE STENT WAS NOT MEASURED DUE TO THE DAMAGE NOTED. DIFFICULTY POSITIONING THE SDS THROUGH THE GUIDING CATHETER, CAUSING RESISTANCE BETWEEN THE TWO DEVICES MAY BE RELATED TO NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, STENT IMPLANT OUTER DIAMETER, DAMAGE TO THE STENT IMPLANT, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. FURTHERMORE, THE INABILITY TO CROSS THE LESION CAN BE AFFECTED BY FACTORS SUCH AS PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, OR ACCESSORY DEVICE SUPPORT, AND IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE LESION WAS REPORTED AS MODERATELY TORTUOUS AND 85% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IN THIS CASE, IT IS POSSIBLE THAT PROXIMAL END OF THE STENT BECAME FLARED AT SOME POINT DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE (RHV), SUCH THAT THE SDS WAS DIFFICULT TO POSITION THROUGH THE GUIDING CATHETER AND COULD NOT CROSS THE LESION. THEN UPON REMOVAL, THE STENT LIKELY INTERACTED WITH THE TIP OF THE GUIDING CATHETER DURING RETRACTION OF THE DEVICE, CAUSING THE STRUTS TO BEND AS A RESULT. THIS INTERACTION ALSO LIKELY CONTRIBUTED TO THE NOTED SHREDDING AT THE BALLOON SEAL. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MANUFACTURING PROCESS AT ABBOTT VASCULAR. ADDITIONALLY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE. BASED ON THE DEVICE LOT HISTORY RECORD REVIEW AND QUERY OF SIMILAR INCIDENTS FOR THIS LOT, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND NO CALCIFICATION. DUE TO THE EFFECT OF FLARED STRUTS ON THE PROFILE OF THE STENT, DIFFICULTY WAS ENCOUNTERED ADVANCING THROUGH THE GUIDING CATHETER AND CROSSING TO THE LESION. NO RESISTANCE DURING REMOVAL WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED BALLOON PEELING.

    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 0090841

    Patients

    Seq Age Sex Outcome Treatment
    1