BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

    MDR report key: 8955050 · Received September 3, 2019

    Report

    Report Number
    2183870-2019-00426
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 29, 2019
    Report Date
    January 16, 2020
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: TWO PHOTOGRAPHS OF CINE IMAGES WERE RECEIVED FOR EVALUATION. THE FIRST IMAGE IS JUST ABOVE THE KNEE THE DISTAL MARKER HOOPS OF THE STENT CAN BE IDENTIFIED. DUE TO THE QUALITY AND CLARITY OF THE IMAGE IT IS NOT POSSIBLE TO IDENTIFY INDIVIDUAL STENT ROWS/CELLS TO DETERMINE IF THE STENT CELLS ARE ELONGATED. THE DISTAL END OF THE STENT IN THE IMAGE DOES NOT APPEAR TO BE FULLY EXPANDED WHEN COMPARED TO THE PROXIMAL END OF THE STENT IN THE IMAGE. THE SECOND IMAGE IS OF THE STENT, A GUIDEWIRE AND A RADIOPAQUE RULER. DUE TO THE QUALITY AND CLARITY OF THE IMAGE IT IS NOT POSSIBLE TO IDENTIFY INDIVIDUAL STENT ROWS/CELLS TO DETERMINE IF THE STENT CELLS ARE ELONGATED. THERE APPEARS TO THREE DISTINCT AREAS WITHIN THE STENTED VESSEL. THE DISTAL AREA NEAR THE BOTTOM OF IMAGE FROM 18 UNITS TO 19 UNITS ON THE RADIOPAQUE RULER THE STENT CELL STRUCTURE DOES NOT APPEAR TO BE UNIFORMED. FROM 19 UNITS TO JUST BEFORE 21 UNITS ON THE RADIOPAQUE RULER THE STENT CELL STRUCTURE DOES NOT APPEAR TO BE FULLY EXPANDED. FROM APPROXIMATELY 21 UNITS TO 23 UNITS ON THE RADIOPAQUE RULER APPEARS TO BE MORE UNIFORM BUT INDIVIDUAL STENT STRUCTURE CELL ROWS CANNOT BE IDENTIFIED. THERE DOES NOT APPEAR TO BE RADIOPAQUE MARKER HOOPS AT THE PROXIMAL END OF THE STENT. THE GUIDEWIRE IN THE SECOND IMAGE DOES NOT APPEAR TO BE A 0.035¿ COMPATIBLE GUIDEWIRE. PER THE INITIAL REPORTED EVENT DESCRIPTION PACIFIC PLUS PTA CATHETERS AND AN EVERCROSS PTA CATHETER WERE BEING USED IN THE PROCEDURE. PACIFIC PLUS PTA CATHETERS ARE 0.018¿ GUIDEWIRE COMPATIBLE. THE GUIDEWIRE IN THE IMAGE IS MOST LIKELY AN 0.018¿ COMPATIBLE GUIDEWIRE. THE TYPE AND EXTENT OF THE DAMAGE TO THE STENT COULD NOT BE POSITIVELY DETERMINED DUE TO THE QUALITY AND CLARITY OF THE IMAGES PROVIDED. PARTS OF THE STENT APPEAR TO BE ELONGATED AND OTHERS APPEAR TO BE NOT FULLY EXPANDED WITHIN THE VESSEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ALL EVERFLEX ENTRUST STENTS WERE DEPLOYED VIA A DORSALIS PEDAL ACCESS. FIRST EVERFLEX ENTRUST STENT WAS DEPLOYED IN THE PROXIMAL SFA, FOLLOWED BY OVERLAPPING STENT IN MID SFA. THE PROBLEMATIC EVERFLEX ENTRUST WAS DEPLOYED IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA)/PROXIMAL POPLITEAL. NO DEPLOYMENT DIFFICULTIES WERE NOTED. FOLLOWING DEPLOYMENT, DISSECTION, PERFORATION AND VESSEL DAMAGE ARE REPORTED. IT IS UNKNOWN IF THIS WAS CAUSED BY THE EVERFLEX ENTRUST. POST-DILATION WAS PERFORMED USING A 6MM PACIFIC PLUS BALLOON, THE PERFORATED AREA WAS CONTAINED, AND FLOW WAS VISIBLE. STENT DEFORMATION IN VIVO IS REPORTED. IT IS REPORTED THAT 120MM OF THE STENT WAS DEPLOYED IN THE VESSEL. THE STENT APPEARED TO HAVE FRACTURED LONGITUDINALLY. NO FURTHER INTERVENTION REPORTED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN EVERFLEX ENTRUST WAS USED WITH A 4/5FR NON-MEDTRONIC SHEATH AND SLENDER 11 CM GUIDEWIRE DURING TREATMENT OF A 300 MM+ CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5 MM. LESION DESCRIBED AS CALCIFIED. SLIGHT TORTUOSITY AND SEVERE CALCIFICATION OF THE VESSEL REPORTED. IFU WAS FOLLOWED, DEVICE PREPPED WITHOUT ISSUE. THE LESION AS PRE-DILATED WITH A 4 MM X 300 MM PACIFIC PLUS PTA BALLOON FOLLOWED BY A 5 X 200 MM EVERCROSS PTA. THE EVERFLEX ENTRUST WAS ADVANCED WITHOUT ISSUE. NO RESISTANCE ENCOUNTERED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THE STENT WAS DEPLOYED VIA A PEDAL APPROACH. STENT DEFORMATION IN VIVO IS REPORTED. IT IS REPORTED THAT 120 MM OF THE STENT WAS DEPLOYED IN THE VESSEL. ADDITIONAL STENTS ARE MENTIONED. IT IS REPORTED PRIOR TO DEPLOYMENT OF THE EVERFLEX ENTRUST, 2 STENTS WERE DEPLOYED USING A RETROGRADE APPROACH. FOLLOWING DEPLOYMENT, A DISSECTION, PERFORATION AND VESSEL DAMAGE ARE REPORTED. POST-DILATION WAS PERFORMED USING A 6 MM BALLOON, AND THE PERFORATED AREA WAS CONTAINED AND FLOW WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750879 EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN A878089

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention