BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 8098821 · Received November 22, 2018

    Report

    Report Number
    2183870-2018-00521
    Event Type
    Injury
    Date Received
    November 22, 2018
    Date of Event
    May 21, 2013
    Report Date
    August 2, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ADVERSE EVENT TERM WAS UPDATED TO THROMBUS RIGHT POPLITEAL. THE THROMBUS CAUSED AN OCCLUSION IN THE POPLITEAL ARTERY WHICH WAS THEN EXTRACTED. IT WAS ALSO REPORTED THAT IN-STENT OCCLUSION BY THROMBUS OF RIGHT POPLITEAL ARTERY IS POSSIBLY BECAUSE OF DISSECTION. IT WAS ALSO REPORTED THAT DURING REVASCULARIZATION, A NON-MEDTRONIC STENT WAS IMPLANTED. CORRECTION: IMPLANT DATE ADDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PROTÉGÉ EVERFLEX 7X100 AND AN INPACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER WAS USED TO TREAT THE PATIENT IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY ((B)(6) 2009). APPROX. 48 MONTHS POST PROCEDURE THE PATIENT SUFFERED A RE-OCCLUSION IN THE RIGHT SFA ((B)(6) 2013) THE PHYSICIAN USED THREE IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS. APPROXIMATELY 58 MONTHS POST THE INDEX PROCEDURE ((B)(6) 2014) THROMBO-ENDARTERECTOMY OF THE TARGET VESSEL WAS CARRIED OUT DUE TO RE-OCCLUSION. THE OUTCOME IS REPORTED AS RESOLVED. APPROXIMATELY 61.5 MONTHS POST THE INDEX PROCEDURE ((B)(6) 2014) SURGICAL INTERVENTION OF THE RIGHT SFA WAS REQUIRED DUE TO AN ANEURYSM SPURIUM ( (B)(6) 2014) WITH REMOVAL OF A BOVINE PATCH OF SFA. THE PATIENT RECOVERED. DURING A REVASCULARIZATION, ON (B)(6) 2017, TO TREAT THE TARGET LESIONS, THREE IN.PACT PACIFIC DCBS WERE USED, ALONG WITH FIVE NON-MEDTRONIC STENTS. APPROXIMATELY 13 MONTHS POST THE REVASCULARIZATION ((B)(6) 2018), ISCHEMIC RIGHT LEG WAS REPORTED. THE TARGET LESIONS WERE TREATED WITH AN UNKNOWN PTA ((B)(6) 2018) AND A THROMBOSUCTION OF TOTAL AFC AND AFS. IT HAS BEEN REPORTED THAT THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938346 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R