BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 11753561 · Received April 30, 2021

    Report

    Report Number
    2017233-2021-01928
    Event Type
    Death
    Date Received
    April 30, 2021
    Date of Event
    April 3, 2020
    Report Date
    April 30, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LITERATURE STATED CONFORMABLE GORE¿ TAG¿ THORACIC ENDOPROSTHESES (CTAG) WERE ALSO UTILIZED IN THE STUDY, SO THIS REPORT INCLUDES THE CTAG PRODUCTS AS WELL. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE TITLED DETERMINING THE OPTIMAL PROXIMAL LANDING ZONE FOR TEVAR IN THE AORTIC ARCH: COMPARING THE OCCURRENCE OF THE BIRD-BEAK PHENOMENON IN ZONE 0 VS ZONES 1 AND 2 (JOURNAL OF ENDOVASCULAR THERAPY (2020, VOL. 27(3) 368376), THE FOLLOWING INFORMATION WAS OBTAINED. ABSTRACT PURPOSE: TO IDENTIFY THE OPTIMAL PROXIMAL LANDING ZONE FOR THORACIC AORTIC ENDOVASCULAR REPAIR (TEVAR) OF AORTIC ARCH PATHOLOGIES SO AS TO AVOID THE BIRD-BEAK PHENOMENON THAT LEADS TO TYPE IA ENDOLEAK. MATERIALS AND METHODS: A RETROSPECTIVE SINGLE-CENTER REVIEW WAS CONDUCTED OF 164 PATIENTS (MEAN AGE 70.3¿10.8 YEARS, RANGE 2993; 127 MEN) WHO UNDERWENT REPAIRS OF THE AORTIC ARCH USING HYBRID TEVAR FROM APRIL 2008 TO MARCH 2017. THE PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO THE PROXIMAL LANDING ZONE: 43 ZONE 0 PATIENTS (26.2%) HAD TOTAL DEBRANCHING TEVAR (N=18) OR TOTAL ENDOVASCULAR AORTIC REPAIR (N=25) WHILE 121 PATIENTS (73.8%) HAD TEVAR LANDING IN ZONES 1 (N=41) OR 2 (N=80). BIRD-BEAK CONFIGURATIONS, ENDOLEAKS, AND STENT MIGRATIONS WERE ASSESSED ON THE POSTOPERATIVE AND LATEST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCANS. OVERALL SURVIVAL AND FREEDOM FROM THE BIRD-BEAK CONFIGURATION, AORTA-RELATED DEATH, AND AORTIC EVENTS WERE ESTIMATED USING THE KAPLAN-MEIER METHOD. HAZARD RATIOS (HR) WERE CALCULATED WITH THE 95% CONFIDENCE INTERVAL (CI). RESULTS: ALL PROCEDURES WERE SUCCESSFUL, WITHOUT ANY 30-DAY MORTALITY. THERE WERE 3 EARLY COMPLICATIONS (1.8%; ALL STROKES) AND 10 EARLY ENDOLEAKS (6.1%; NO TYPE IA). ON THE FIRST POSTOPERATIVE CTA, 42 PATIENTS (25.6%) HAD A BIRD-BEAK CONFIGURATION. THE ZONE 0 PATIENTS HAD SIGNIFICANTLY FEWER (P<0.001), SHORTER (P<0.004), AND LESS ANGULATED (P<0.001) BIRD-BEAK CONFIGURATIONS THAN IN ZONES 12. THE MEAN FOLLOW-UP PERIOD WAS 4.2 YEARS (RANGE 0.58.8). THERE WERE 18 LATE DEATHS (11.0%); ONLY ONE WAS RELATED TO THE AORTA (RUPTURE DUE TO A TYPE IB ENDOLEAK IN A ZONE 0 PATIENT). THE 5-YEAR FREEDOM FROM AORTA-RELATED DEATH WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS (ZONE 0: 96.9% VS ZONES 12: 100%, P=0.080). ON THE LATEST CTA, 51 (31.0%) PATIENTS HAD A BIRD-BEAK CONFIGURATION; OF THOSE, 22 (13.4%) SHOWED >3- MM PROGRESSION. THE FREEDOM FROM BIRD-BEAK CONFIGURATION ESTIMATE WAS SIGNIFICANTLY HIGHER IN THE ZONE 0 GROUP (95.4%) VS ZONES 12 (57.8%; HR 0.10, 95% CI 0.02 TO 0.31, P<0.001). THERE WERE 9 LATE ENDOLEAKS (4 TYPE IA; NONE IN THE ZONE 0 GROUP). THE RATE OF STENT-GRAFT MIGRATION WAS SIGNIFICANTLY LOWER IN THE ZONE 0 GROUP (2.3% VS 14.1% IN ZONES 12, P=0.035). CONCLUSION: EARLY AND MOST LATE RESULTS IN ZONE 0 TEVAR WERE EQUAL TO THOSE IN ZONES 1 AND 2; HOWEVER, THERE WERE NO LATE TYPE IA ENDOLEAKS AND FEWER BIRD-BEAK CONFIGURATIONS ASSOCIATED WITH ZONE 0 TEVAR, WHICH SUGGESTS THAT ZONE 0 LANDING IS ADVANTAGEOUS FOR PREVENTING THESE COMPLICATIONS. IT WAS REPORTED THAT 60 GORE¿ TAG¿ THORACIC ENDOPROSTHESES AND 32 GORE¿ TAG¿ CONFORMABLE THORACIC ENDOPROSTHESES WERE USED. THE FOLLOWING COMPLICATIONS WERE IDENTIFIED: 3 EARLY STROKES (EVENT CODE CAPTURED AS 1001-E), 7 TYPE II ENDOLEAK, BIRD-BEAK (EARLY;42, LATE;51), 4 1A ENDOLEAK WITH RE-INTERVENTION (OPEN SURGICAL REPAIRS AND TEVAR), 7 1B ENDOLEAK WITH RE-INTERVENTION (ADDITIONAL TEVAR), 1 1B ENDOLEAK WITH ANEURYSM RUPTURE AND DEATH,18 MIGRATION THIS REPORT CAPTURES IB ENDOLEAK WITH ANEURYSM RUPTURE AND DEATH. THE OTHER REPORTABLE COMPLICATIONS ARE BEING REPORTED SEPARATELY. THE PATIENT AGE REFLECTS THE AVERAGE AGE OF PATIENTS IN THE ARTICLE. THE DATE OF EVENT REFLECTS THE DATE THE ARTICLE WAS E-PUBLISHED IN THE PUBMED ORG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653272 GORE TAG THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| O| R