BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 2032913 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02128
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. FURTHERMORE, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT WITHIN THE BODY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION OR FROM AN INTERACTION WITH OTHER DEVICES, THE PATIENT ANATOMY AND/OR A PREVIOUSLY IMPLANTED STENT. BASED ON THE INFORMATION PROVIDED, THE LESION WAS HEAVILY TORTUOUS AND HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, ON THE SHAFT AND ON THE BALLOON, WHICH IS CONSISTENT WITH THE DEVICE BEING LOADED ONTO THE GUIDE WIRE AND INTO THE PATIENT. THERE WAS ALSO CONTRACT VISIBLE IN THE INFLATION LUMEN AND BALLOON, SUGGESTING THAT THE SDS WAS PREPARED FOR USE. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED WITH THE SDS, CONFIRMING THE REPORTED COMPLAINT. HOWEVER, THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IT WAS NOTED THAT THE BALLOON WAS FOUND TO BE LOOSELY-FOLDED, WHICH MAY SUGGEST THAT SIGNIFICANT PRESSURE WAS INADVERTENTLY APPLIED TO THE SDS DURING HANDLING POST-PROCEDURE, ALTHOUGH THIS CANNOT BE CONFIRMED. THE SDS LIKELY INTERACTED WITH THE TORTUOUS AND CALCIFIED LESION SUCH THAT IT WAS UNABLE TO CROSS, CAUSING THE STENT TO BECOME DISRUPTED ON THE BALLOON AND DISLODGE AS A RESULT. ALSO NOTED DURING THE ANALYSIS WAS A KINK IN THE BAYONET PORTION OF THE HYPOTUBE, 0.5 MM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THE MATERIAL AT THE PROXIMAL END OF THE GUIDE WIRE EXIT NOTCH IN THE SAME AREA WAS ALSO LIFTED, WHICH WAS LIKELY DUE TO THE KINK IN THE SHAFT. ADDITIONALLY, THERE WAS A BEND IN THE HYPOTUBE LOCATED 64.4 CM DISTAL TO THE STRAIN RELIEF TUBING. HOWEVER, SINCE THIS DAMAGE WAS NOT ORIGINALLY REPORTED, THE SHAFT LIKELY KINKED FROM FURTHER HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED COMPLAINT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED DEVICE, THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT MOVEMENT TO VERIFY STENT SECURITY AND DISLODGMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTW ULTRA STENT IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY. BOTH ULTRA STENTS DISLODGED DURING THE CROSSING ATTEMPT, DUE TO CALCIUM AND TORTUOSITY. THE STENTS WERE EACH RETRIEVED WITH A SNARE DEVICE. NO PATIENT EFFECTS WERE REPORTED. THE PROCEDURE WAS COMPLETED AT THAT POINT AND NO OTHER STENTS WERE ATTEMPTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0042741

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention