BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 10920168 · Received November 30, 2020

    Report

    Report Number
    2183870-2020-00405
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    October 18, 2020
    Report Date
    November 30, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K072301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: REVASCULARIZATION OF OCCLUDED RENAL ARTERY STENT-GRAFTS FOLLOWING COMPLEX ENDOVASCULAR AORTIC REPAIR AND ITS IMPACT ON RENAL FUNCTION PII: S0741-5214(20)32274-6 DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.036. REFERENCE: YMVA 11630 TO APPEAR IN: JOURNAL OF VASCULAR SURGERY. AGE: AVERAGE AGE. SEX: MAJORITY GENDER. EVENT DATE: DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A RETROSPECTIVE, MULTI-CENTRE STUDY ACROSS 11 TERTIARY INSTITUTIONS OF ALL CONSECUTIVE PATIENTS THAT UNDERWENT REVASCULARIZATION OF RENAL ARTERY STENT-GRAFT OCCLUSIONS AFTER COMPLEX EVAR. 38 PATIENTS WITH 46 TARGET VESSELS WERE INCLUDED IN THE STUDY. MEDTRONIC¿S PROTÉGÉ, EVERFLEX AND VISIPRO STENT SYSTEMS WERE IMPLANTED AS BRIDGING STENT GRAFTS DURING THE PROCEDURES. TECHNICAL SUCCESS OF THE RECANALIZATION PROCEDURE WAS 95.7% (44/46 TVS): CATHETERIZATION OF 2 TARGET VESSELS WAS UNSUCCESSFUL. ONE PATIENT DIED AFTER CARDIAC ARREST OF UNKNOWN CAUSE ON THE 10TH POSTOPERATIVE DAY. NO MAJOR STROKES OCCURRED. FOUR PATIENTS (10.5%) PRESENTED ACCESS-RELATED VASCULAR COMPLICATIONS, OF WHICH ONE (2.6%) UNDERWENT SURGICAL TREATMENT FOR A BRACHIAL ARTERY OCCLUSION DIRECTLY POSTOPERATIVELY. FIVE OF THE THIRTY-EIGHT PATIENTS (13.2%) WERE LOST TO FOLLOW-UP, NONE OF WHICH WAS HEMODIALYSIS-DEPENDENT AT THE TIME OF DISCHARGE. OF THE REMAINING 33 PATIENTS, NINE REQUIRED PERMANENT HEMODIALYSIS (23.7%) AND ONE PATIENT PREVIOUSLY HEMODIALYSIS-DEPENDENT HAD UNDERGONE A KIDNEY TRANSPLANT. FIVE PATIENTS REQUIRED PROCEDURAL RELATED REINTERVENTIONS DURING FOLLOW-UP: 1 RENAL STENT-GRAFT RELINING DUE TO STENOSIS ON THE 2ND POSTOPERATIVE MONTH (POM); 1 ATTEMPTED RECANALIZATION OF A DISTAL RENAL ARTERY STENT-GRAFT RE-STENOSIS ON THE 2ND 7 POM, THE PROCEDURE WAS HOWEVER ABORTED BECAUSE OF INTRAPROCEDURAL TRANSIENT ISCHEMIC ATTACK OF THE PATIENT; 1 RECANALIZATION OF THE RENAL STENT-GRAFT DUE TO NEW OCCLUSION ON THE 3RD POM; 1 DRUG-COATED BALLOON ANGIOPLASTY TO TREAT A DISTAL RENAL STENT-GRAFT STENOSIS ON THE 24TH POM AND ONE RELINING OF THE RENAL STENT-GRAFT DUE TO STENOSIS ON THE 57TH POM (2.6% EACH). NO REDUCTION IN THE GFR VALUE WAS OBSERVED IN THE PATIENT WITH THE RE-OCCLUSION. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE(S) AND THE DEATH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387568 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention