BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2067373 · Received April 22, 2011

    Report

    Report Number
    2024168-2011-02834
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND DISTAL SHAFT, CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THERE WAS CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. A NEW INDEFLATOR WAS FILLED WITH WATER AND USED TO PRESSURIZE THE STENT DELIVERY SYSTEM (SDS). THERE WERE TWO HOLES IN THE DISTAL TAPER, CONFIRMING THE REPORTED INFORMATION. BOTH HOLES WERE WITHIN 1 MM FROM THE DISTAL MARKER. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE FROM THE STENT, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE LESION/ANATOMY AND/OR GUIDING CATHETER/GUIDE WIRE. THERE WAS NO REPORT OF ANY LEAK OR DAMAGE TO THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES AND/OR THE LESION/ANATOMY. A CONCLUSIVE CAUSE FOR THE NOTED TEAR IN THE BALLOON COULD NOT BE DETERMINED. 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 HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES OR TEARS IN THE BALLOON FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: RUNTHROUGH NS FLOPPY. GUIDE CATH: HEARTRAIL 5 F JL 4. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, PRE-DILATATION WAS PERFORMED USING A TREK BALLOON. A 2.5 X 12 XIENCE V STENT SYSTEM WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED. THE BALLOON RUPTURED BETWEEN 1-4 ATMOSPHERES. THE STENT SYSTEM WAS REMOVED FROM THE ANATOMY. OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THE BALLOON WAS LEAKING AND TWO PINHOLES WERE CONFIRMED. THE STENT REMAINED ON THE BALLOON. A NEW XIENCE STENT OF THE SAME SIZE WAS DEPLOYED AT 12 ATMOSPHERES SUCCESSFULLY TREATING THE TARGET LESION. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. 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 0100641

    Patients

    Seq Age Sex Outcome Treatment
    1