BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2220990 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05924
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: STENT: 2.5 X 18 MM XIENCE. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V RX STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE BALLOON, STENT IMPLANT AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE TWO FLARED STRUTS ON THE FIRST ROW AT THE PROXIMAL END OF THE STENT IMPLANT, CONFIRMING THE REPORTED STENT DAMAGE. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE 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 GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE SDS WAS ADVANCED THROUGH A NEW 6FR GUIDING CATHETER AND REMOVED WITH NO RESISTANCE NOTED. 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. THE PATIENT ANATOMY WAS DIFFUSELY DISEASED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE DEVICE. IT IS LIKELY THAT THE STENT INTERACTED WITH THE LESION DURING RETRACTION, DAMAGING THE STRUT, AND CONTRIBUTING TO THE DIFFICULTY REMOVING THE SDS THROUGH THE GUIDING CATHETER DURING RETRACTION. 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 DIFFICULT TO REMOVE FOR THIS LOT. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Description of Event or Problem · 1

    REPORTEDLY, THE TARGET LESION WAS LOCATED IN A BIFURCATION INVOLVING THE RIGHT POSTERIOR LATERAL (RPL) AND RIGHT POSTERIOR DESCENDING ARTERIES (RPD) WITH DIFFUSE DISEASE WHICH HAD BEEN PREVIOUSLY STENTED. PREDILATATION WAS DONE USING TWO TREK DILATATION BALLOON CATHETERS (2.5X20 MM, 2.5X12 MM) IN A KISSING BALLOON TECHNIQUE. A 2.5X18 MM XIENCE WAS SUCCESSFULLY IMPLANTED IN THE RPL AND A 2.75X28 MM XIENCE WAS ADVANCED TO TREAT THE RPD; HOWEVER, THE 2.75X28 MM XIENCE FAILED TO CROSS AND UPON RETRACTION INTO A NON-ABBOTT GUIDING CATHETER, RESISTANCE WAS FELT. A STRUT WAS NOTED TO BE FLARED UPON RETRACTION OF THE DEVICE OUTSIDE OF THE PATIENT ANATOMY. ANOTHER SHORTER XIENCE WAS USED TO SUCCESSFULLY TREAT THE RPD WITH OUT FURTHER INCIDENT. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT 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 1042841

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR