BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2130402 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04232
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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. INFLATION: SMITHS MEDICAL. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT AS REPORTED. THE STYLET WAS RETURNED INSERTED IN THE GUIDE WIRE LUMEN AND YELLOW PROTECTIVE SHEATH OVER THE BALLOON. THE HYPOTUBE WAS SEPARATED 22.6CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE SEPARATION. THE FRACTURE FACES WERE OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS SEPARATED AT THE SAME LOCATION. THE JACKET MATERIAL AT THE HYPOTUBE SEPARATION WAS STRETCHED AND JAGGED. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. 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. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT WAS REPORTED THE SDS WAS ROTATED IN THE ATTEMPTS TO CROSS THE LESION, WHICH LIKELY CONTRIBUTED TO THE SHAFT BENDING AND KINKING IN THE MODERATELY TORTUOUS ANATOMY. FURTHER MANIPULATION WOULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING, AND FURTHER CONTRIBUTING TO THE RESISTANCE DURING RETRACTION OF THE SDS. THE REPORTED STENT DAMAGE WAS UNABLE TO BE CONFIRMED; HOWEVER, THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING THE SDS, AND HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR DIFFICULT TO REMOVE OR HYPOTUBE SEPARATION FOR THIS LOT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX ARTERY. AN ATTEMPT WAS MADE TO ADVANCE THE XIENCE STENT DELIVERY SYSTEM (SDS); HOWEVER, THE DEVICE DID NOT CROSS THE LESION. IT WAS NOTED THAT THE STENT STRUTS WERE TWISTED; THEREFORE, ANOTHER XIENCE AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED A PROXIMAL SHAFT SEPARATION. FOLLOW-UP INFORMATION REPORTED THAT DURING ADVANCEMENT OF THE SDS, ROTATIONS WERE MADE WITH THE DEVICE IN AN ATTEMPT TO CROSS THE LESION. THIS RESULTED IN A PROXIMAL SHAFT SEPARATION, WHICH WAS NOTED DURING REMOVAL. THE SEPARATED PORTION WAS REMOVED ON THE GUIDE WIRE. IT WAS ALSO REPORTED THAT RESISTANCE WAS NOTED DURING REMOVAL OF THE SDS.

    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 0120341

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR