BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1984303 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00801
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST VISIBLE IN THE HUB, INFLATION LUMEN, GUIDE WIRE LUMEN, AND BALLOON, WHICH IS CONSISTENT WITH A LEAK WHILE IN THE PATIENT ANATOMY. THE INNER AND OUTER MEMBERS WERE TORN AT THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 1.7 CM. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE SDS WHEN FLUID LEAKED OUT OF THE TEAR IN THE DISTAL SHAFT. THE DISTAL SHAFT WAS CUT 2 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL AND THE BALLOON WAS PRESSURIZED USING A LUER. THERE WAS NO RUPTURE NOTED AS REPORTED. IN THIS CASE, IT IS LIKELY THAT THE TEAR IN THE SHAFT WAS WHAT WAS PERCEIVED BY THE ACCOUNT AS THE BALLOON RUPTURE. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE SHAFT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDE WIRE. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY PRIOR TO RELEASE. SINCE THERE WAS NO REPORT OF ANY LEAKS OR DAMAGE NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE SHAFT WAS NOT LIKELY DAMAGED PRIOR TO USE. THE TEARING OF THE GUIDE WIRE EXIT NOTCH APPEARS TO HAVE RESULTED FROM AN INTERACTION WITH THE GUIDE WIRE. THIS TYPE OF MECHANICAL DAMAGE CAN OCCUR IF AN ATTEMPT IS MADE TO PULL THE CATHETER IN AN OPPOSITE DIRECTION AS THE GUIDE WIRE. IT WAS REPORTED THE XIENCE V WAS USED TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED STENT. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 3.75MM. SAFETY AND EFFECTIVENESS OF THE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IT IS UNKNOWN HOW THE USE OF THE XIENCE V TO TREAT IN-STENT RESTENOSIS MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XIENCE V STENT WAS DEPLOYED OVERLAPPING A PREVIOUSLY DEPLOYED NON-ABBOTT STENT IN THE CIRCUMFLEX ARTERY TO TREAT RESTENOSIS. UPON SECOND INFLATION OF THE XIENCE V STENT DELIVERY SYSTEM (SDS), THE PHYSICIAN NOTED AN ISSUE WITH THE BALLOON AND WITHDREW THE SDS, WHICH REVEALED A RUPTURED BALLOON. NO PATIENT EFFECTS WERE REPORTED. 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 0091042

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: ENDEAVOR