BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 8825810 · Received July 25, 2019

    Report

    Report Number
    2183870-2019-00381
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 23, 2019
    Report Date
    October 11, 2019
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    PRODUCT ANALYSIS: THE EVERFLEX ENTRUST STENT DELIVERY SYSTEM (SDS) WAS RECEIVED FOR EVALUATION. NO ANCILLARY DEVICES OR CINES FROM THE PROCEDURE WERE RECEIVED. THE ENTRUST SDS WAS RECEIVED WITH A PORTION OF THE STENT PROTRUDING FROM THE DISTAL END OF THE OUTER SHEATH OF THE SDS CATHETER. IT IS NOTED THAT THE OUTER SHEATH HAS SEVERAL ZONES OF LATERAL COMPRESSION IN THE PORTION THAT HOUSES THE STENT. THESE ZONES OF LATERAL COMPRESSION WOULD INCREASE THE DEPLOYMENT FORCE AND STENT DEPLOYMENT ABILITY OF THE ENTRUST SDS. THE ENTRUST DEPLOYMENT HANDLE WAS RECEIVED WITH THE RED LOCKING TAB AND TUBE REMOVED; THEY WERE NOT RECEIVED AS PART OF THE RETURNED DEVICE. THE PULL CABLE WAS NOTED TO BE PROTRUDING FROM THE DEPLOYMENT HANDLE THUMBWHEEL CAVITY. ZONES OF LATERAL COMPRESSION IN THE OUTER SHEATH WERE NOTED A SHARP KINK IN THE OUTER SHEATH WAS NOTED APPROXIMATELY 40.5CM FROM THE DISTAL END OF THE STENT, AND THE DISTAL END OF THE INNER GUIDEWIRE LUMEN PUSHER IS LOCATED APPROXIMATELY 40.8CM FROM THE DISTAL END OF THE STENT. NO OTHER ANOMALIES WERE NOTED IN REST OF THE LENGTH OF THE SDS CATHETER. THE PRINTED STRAIN RELIEF WAS REMOVED FROM THE DEPLOYMENT HANDLE AND THE HANDLE WAS SPLIT OPEN ALONG ITS SEAM. THE PULL CABLE APPEARS TO HAVE BEEN ROUTED PROPERLY THROUGH THE HANDLE; NO UNUSUAL WEARS MARKS WERE NOTED. THE PROXIMAL END OF THE INNER GUIDEWIRE LUMEN NEXT TO ITS PROXIMAL HUB EXHIBITS A SMALL AMOUNT OF ACCORDION FOLDING, INDICATING THAT THE INNER GUIDEWIRE LUMEN HAD A FORCE APPLIED TO IT. THE PROXIMAL END OF THE INNER GUIDEWIRE LUMEN WAS CUT TO ALLOW FURTHER EXAMINATION OF THE SDS CATHETER. THE PRINTED STRAIN RELIEF AND ISOLATION SHEATH WAS SLID PROXIMALLY OVER AND OFF THE INNER GUIDEWIRE LUMEN TO EXPOSE THE PROXIMAL END OF THE OUTER SHEATH. THE PROXIMAL END OF THE OUTER SHEATH SHOWS DAMAGE OF THE PULL CABLE BEING PULLED OUT OF ITS BOND TO THE OUTER SHEATH. THIS INDICATES THAT A DEPLOYMENT FORCE GREATER THAN 8.0LBS WAS APPLIED. SANGUINE RESIDUE WAS NOTED ON THE OUTER SHEATH AND THE INNER GUIDEWIRE LUMEN. THE PROXIMAL END OF THE STENT WAS LOCATED USING BACK LIGHTING AND ITS POSITION WAS MARKED ON THE OUTER SHEATH. THE PROXIMAL END OF THE STENT IS LOCATED APPROXIMATELY 12.7CM FROM THE DISTAL END OF THE OUTER SHEATH. THE DISTAL END OF THE INNER GUIDEWIRE LUMEN/PUSHER IS LOCATED APPROXIMATELY 40.8CM. THE 28.1CM DISTANCE BETWEEN THE PROXIMAL END OF THE STENT AND THE DISTAL END OF THE INNER GUIDEWIRE LUMEN INDICATES THAT THE OUTER SHEATH SLID DISTALLY DURING THE REMOVAL OF THE SDS. 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

    PHYSICIAN INTENDED TO USE AN EVERFLEX ENTRUST WITH A 6FR, 45CM LONG SHEATH AND FLOPPY TIP GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS PROXIMAL AND DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. VESSEL DIAMETER REPORTED AS 5MM. SLIGHT TORTUOSITY AND SEVERE CALCIFICATION REPORTED. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. A NON-MEDTRONIC 5MM PTA BALLOON WAS USED FOR PRE-DILATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT WITHOUT ANY RESISTANCE. THE LOCK-PIN WAS REMOVED WHEN THE STENT WAS POSITIONED PRIOR TO ATTEMPTED DEPLOYMENT. DEPLOYMENT DIFFICULTIES WERE EXPERIENCED. IT IS REPORTED THE THUMB WHEEL WAS TURNING INTO THE VOID AND IT WAS NOT POSSIBLE TO DEPLOY THE STENT AT ALL. THE WHOLE STENT SYSTEM WAS WITHDRAWN THROUGH THE SHEATH AND IT WAS OBSERVED THAT A TINY PART OF THE STENT HAD DEPLOYED (2MM). A DIFFERENT SIZED EVERFLEX ENTRUST WAS THEN USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622283 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN A823402

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR