BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2192183 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05518
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: CROSS IT. INFLATION: MEDTRONIC. GUIDE CATH: CORDIS. SHEATH: CORDIS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE BALLOON AND STENT IMPLANT, CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE PROXIMAL END OF THE BALLOON WAS WRINKLED; THE REST OF THE BALLOON WAS TIGHTLY FOLDED. THE DISTAL SHAFT WAS SEPARATED 7 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH AT THE LAP JOINT, CONFIRMING THE REPORTED SEPARATION. THE INNER MEMBER WAS ALSO SEPARATED AND STICKING OUT OF THE INFLATION LUMEN 7.9 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE KINKS IN THE HYPOTUBE SHAFT 17 CM, 19 CM, 21 CM AND 110.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THE DISTAL SHAFT WAS WAVY IN APPEARANCE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. 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, AND ACCESSORY DEVICE SUPPORT. IT IS LIKELY THAT INTERACTION WITH THE HEAVILY CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING RETRACTION IN THE LESION IF RESISTANCE WAS ENCOUNTERED MAY HAVE RESULTED IN THE BALLOON WRINKLING AND SHAFT SEPARATING AS THERE WAS NO DAMAGE NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY CATHETER TENSILE INTEGRITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR SHAFT SEPARATIONS FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION; HOWEVER, THE 2.5 X 18 MM XIENCE V DID NOT CROSS. ADDITIONALLY, DUE TO HEAVY CALCIFICATION, THE DISTAL SHAFT OF THE DEVICE SEPARATED. THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT IS DOING FINE AND IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9081041

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR