BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4655799 · Received April 3, 2015

    Report

    Report Number
    2024168-2015-01770
    Event Type
    Malfunction
    Date Received
    April 3, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 13, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CASE DESCRIPTION CONTINUED: ONCE OUTSIDE OF THE PATIENT, THE STENT WAS CONFIRMED TO BE FULLY DISLODGED FROM THE BALLOON INSIDE OF THE GUIDE CATHETER EXTENSION. A THIRD NON-ABBOTT GUIDE CATHETER EXTENSION WAS INTRODUCED. A 3.5X12 NON-ABBOTT SDS WAS ADVANCED WITH RESISTANCE AT THE ENTRY POINT OF THE GUIDE CATHETER EXTENSION, BUT WAS ABLE TO BE SUCCESSFULLY PLACED ADJACENT TO THE DISLODGED 4.0X8MM (LOT#4102341) RX XIENCE ALPINE STENT IN THE RCA TO SUCCESSFULLY CRUSH THE STENT TO THE VESSEL WALL. THE RESTENOSED STENT IN THE MID RCA WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY ONLY. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION OR STENT DISLODGEMENT FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: IF UNUSUAL RESISTANCE IS FELT BEFORE THE STENT EXITS THE GUIDING CATHETER, DO NOT FORCE PASSAGE. RESISTANCE MAY INDICATE A PROBLEM AND THE USE OF EXCESSIVE FORCE MAY RESULT IN STENT DAMAGE OR DISLODGEMENT. MAINTAIN GUIDE WIRE PLACEMENT ACROSS THE LESION AND REMOVE THE DELIVERY SYSTEM AND GUIDING CATHETER AS A SINGLE UNIT. THE ADDITIONAL XIENCE ALPINES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSED STENT IN THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THERE WAS ALSO A PREVIOUSLY IMPLANTED STENT IN THE OSTIUM OF THE RCA WHICH EXTENDED A FEW MM IN THE AORTA. A 4.0X8MM (LOT#4102341) RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED INTO A NON-ABBOTT GUIDE CATHETER EXTENSION; HOWEVER, MET RESISTANCE PASSING THROUGH THE ENTRY POINT OF THE GUIDE CATHETER EXTENSION. SLIGHT FORCE WAS APPLIED IN AN ATTEMPT TO EXIT THE CATHETER EXTENSION AND THE STENT WAS NOTED TO BE DISLODGED AND BECAME FREE FLOATING IN THE MID RCA. A SNARE DEVICE AND A 1.5 BALLOON CATHETER WERE USED IN AN ATTEMPT TO RETRIEVE THE DISLODGED STENT; HOWEVER BOTH ATTEMPTS WERE UNSUCCESSFUL. ANOTHER 4.0X8MM (LOT#5010541) RX XIENCE ALPINE SDS WAS ADVANCED IN AN ATTEMPT TO CRUSH THE DISLODGED STENT TO THE VESSEL WALL; HOWEVER, RESISTANCE WAS MET AGAIN AT THE ENTRY POINT OF THE GUIDE CATHETER EXTENSION. SLIGHT FORCE WAS APPLIED AND THIS STENT ALSO DISLODGED FROM THE BALLOON. THE SDS WAS WITHDRAWN BUT THE DISLODGED STENT COULD NOT BE LOCATED AND WAS THOUGHT TO HAVE GONE INTO THE LOWER BODY AS IT WAS NOT FOUND IN THE AORTA OR RCA. THE PATIENT REMAINED IN STABLE CONDITION. THE GUIDE CATHETER EXTENSION WAS REPLACED WITH A NEW NON-ABBOTT GUIDE CATHETER EXTENSION. A 3.5X12MM RX XIENCE ALPINE SDS WAS ADVANCED; HOWEVER, RESISTANCE WAS MET AGAIN AT THE ENTRY POINT OF THE GUIDE CATHETER EXTENSION. SLIGHT FORCE WAS APPLIED; HOWEVER, THE STENT WAS NOTED TO BE PARTIALLY DISLODGED FROM THE BALLOON INSIDE OF THE GUIDE CATHETER EXTENSION; THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221360 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4111141

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR OTHER: GUIDE LINER, STENT: 4.0X8MM XIENCE ALPINE