BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG

    MDR report key: 8417252 · Received March 13, 2019

    Report

    Report Number
    2183870-2019-00125
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 26, 2019
    Report Date
    July 2, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    UDI-DI
    00821684069240
    PMA / PMN Number
    K072301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: NO PROBLEMS WERE IDENTIFIED WITH THE STERILIZATION OF LOT A232926 OR THE EXPIRATION DATE ON THE PRODUCT LABELS. THE PROTÉGÉ STENTS PRODUCT LINE DESIGN VERIFICATION TESTING INCLUDES AN ACCELERATED AGING TEST THAT DEMONSTRATES THE STRUCTURAL AND FUNCTIONAL INTEGRITY OF THE STENT FOR 37 MONTHS POST STERILIZATION. STERILITY INTEGRITY OF THE PRODUCT IS TYPICALLY MAINTAINED WELL AFTER THE EXPIRATION DATE AS LONG AS THE STERILE-PACKAGING IS NOT COMPROMISED. IN THIS EVENT, THERE WAS NO ISSUE WITH THE PACKAGE OR WITH THE DEVICE IN THE TRAY/HOOP. ONCE SUCCESSFULLY IMPLANTED, THE MATERIAL COMPONENTS OF THE STENT, (NITINOL SCAFFOLDING AND TANTALUM MARKERS), SHOULD NOT BE CHEMICALLY OR STRUCTURALLY ANY DIFFERENT REGARDLESS OF WHETHER IT WAS IMPLANTED BEFORE OR AFTER ITS¿ EXPIRATION DATE. THERE IS NO INDICATION THAT THE PRODUCT WAS INCORRECTLY LABELED RELEVANT TO THE EXPIRATION DATE. THE MOST PROBABLE CAUSE IS USER ERROR. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE EF SELF-EXPANDING STENT TO TREAT A 400MM FIBROUS LESION WITH MODERATE CALCIFICATION AND 90% STENOSIS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE TORTUOSITY WAS REPORTED. ARTERY DIAMETER WAS 6MM. A NON-MEDTRONIC 6FR 45CM SHEATH AND A NON-MEDTRONIC GLIDEWIRE 0.35 X 260 SHEATH WERE USED IN THIS PROCEDURE. NO EMBOLIC PROTECTION WAS USED, NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY), NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED, THE LESION WAS PRE-DILATED WITH AN IN.PACT ADMIRAL (5X200). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE STENT WAS PLACED WITHOUT ANY PROBLEMS AND POST DILATED WITH A 6X200 A NON MEDTRONIC (BSC CHARGER) BALLOON. IT WAS REPORTED THAT THE STENT WAS IMPLANTED 3 DAYS POST EXPIRY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210665 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN A232926 00821684069240

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR