BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRASTENT LD MEGA LD

    MDR report key: 11796118 · Received May 10, 2021

    Report

    Report Number
    2183870-2021-00171
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    November 29, 2019
    Report Date
    May 10, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K020528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE SAFETY AND EFFICACY OF STENTING FOR AORTIC ARCH HYPOPLASIA IN PATIENTS WITH COARCTATION OF THE AORTA NETH HEART J (2020) 28:145¿152 HTTPS://DOI.ORG/10.1007/S12471-019-01353-5. MAJORITY GENDER, AVERAGE AGE, DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT BACKGROUND DESPITE A SUCCESSFUL REPAIR PROCEDURE FOR COARCTATION OF THE AORTA (COA), UP TO TWO-THIRDS OF PATIENTS REMAIN HY PERTENSIVE. COA IS OFTEN SEEN IN COMBINATION WITH ABNORMAL AORTIC ARCH ANATOMY AND MORPHOLOGY. THIS MIGHT BE A SUBSTRATE FOR PERSISTENT HYPERTENSION. THEREFORE, WE PERFORMED ENDOVASCULAR AORTIC ARCH STENT PLACEMENT IN PATIENTS WITH COA AND CONCOMITANT AORTIC ARCH HYPOPLASIA OR GOTHIC ARCH MORPHOLOGY. THE GOAL OF THIS RETROSPECTIVE ANALYSIS WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF AORTIC ARCH STENTING. METHODS A RETROSPECTIVE ANALYSIS WAS PERFORMED IN PATIENTS WHO UNDERWENT STENTING OF THE AORTIC ARCH AT THE UNIVERSITY MEDICAL CENTER UTRECHT. MEASUREMENTS COLLECTED INCLUDED OFFICE BLOOD PRESSURE, USE OF ANTIHYPERTENSIVE MEDICATION, INVASIVE PEAK-TO-PEAK SYSTOLIC PRESSURE OVER THE ARCH, AND AORTIC DIAMETERS ON THREE-DIMENSIONAL ANGIOGRAPHY. DATA ON FOLLOW-UP WERE OBTAINED AT THE DATE OF MOST RECENT OUTPATIENT VISIT. RESULTS TWELVE PATIENTS UNDERWENT STENTING OF THE AORTIC ARCH. MEAN FOLLOW-UP DURATION WAS 14 ± 11 MONTHS. MEAN PEAK-TO-PEAK GRADIENT ACROSS THE ARCH DECREASED FROM 39 ± 13MMHG TO 7 ± 8MMHG DIRECTLY AFTER STENTING (P<(><<)> 0.001). THERE WERE NO MAJOR PROE.G. WARMERDAM AND G.J. KRINGS CONTRIBUTED EQUALLY TO THE MANUSCRIPT. THERE WERE NO MAJOR PRO CEDURAL COMPLICATIONS. MEAN SYSTOLIC BLOOD PRESSURE DECREASED FROM 145 ± 16MMHG AT BASELINE TO 128 ± 9MMHG AT LATEST FOLLOW-UP (P= 0.014). CONCLUSION THIS RETROSPECTIVE STUDY SHOWS THAT STENTING OF THE AORTIC ARCH IS SUCCESSFUL WHEN CARRIED OUT IN A STATE-OF-THE-ART MANNER. A DIRECT OPTIMAL ANGIOGRAPHIC AND HAEMODYNAMIC RESULT WAS SHOWN. NO MAJOR COMPLICATIONS OCCURRED DURING OR AFTER THE PROCEDURE. AT SHORT- TO MEDIUM-TERM FOLLOW-UP A DECREASE IN MEAN SYSTOLIC BLOOD PRESSURE WAS OBSERVED. BETWEEN APRIL 2014 AND JANUARY 2018 A TOTAL OF 12 PATIENTS WITH A MEAN AGE OF 24 ± 8 YEARS UNDERWENT STENTING FOR AORTIC ARCH HYPOPLASIA OR GOTHIC ARCH MORPHOLOGY. ELEVEN PATIENTS PREVIOUSLY HAD SOME FORM OF COA REPAIR, ONE PATIENT HAD A NATIVE COA. ELEVEN PATIENTS HAD A HYPOPLASTIC AORTIC ARCH, ONE PATIENT HAD A GOTHIC ARCH MORPHOLOGY. TEN PATIENTS HAD CONCOMITANT CONGENITAL CARDIAC DEFECTS. FOLLOW-UP DATA WERE AVAILABLE FOR ALL PATIENTS; MEAN FOLLOW-UP DURATION WAS 14 ± 11 MONTHS. FEMORAL ARTERY SHEATH SIZES RANGED FROM 8¿14 FRENCH. DURING THE STENTING PROCEDURE 21 STENTS WERE USED IN A TOTAL OF 12 PATIENTS: THE CP STENT WAS USED IN 6 (50%) PATIENTS, THE EV3 MAX LD STENT WAS USED IN 5 (42%) PATIENTS, THE EV3 MEGA LD STENT WAS USED IN 3 (25%) PATIENTS, AND THE ANDRA XXL STENT WAS USED IN 1 (8%) PATIENT. NO MAJOR COMPLICATIONS OCCURRED DURING THE PROCEDURE OR FOLLOW-UP, WE OBSERVED THREE MINOR COMPLICATIONS. A TEMPORARY THIRD-DEGREE ATRIOVENTRICULAR BLOCK OCCURRED IN ONE PATIENT. DURING THE POST-IMPLANTATION REDILATATION OF ONE OF THE STENTS A STENT FRACTURE OCCURRED IN ONE PATIENT, WHICH WAS RESOLVED BY PLACEMENT OF A COVERED STENT. ONE PATIENT EXPERIENCED MINOR REBLEEDING OF THE ACCESS SITE, WHICH WAS MANAGED WITH A SIMPLE BANDAGE. NO ENDOVASCULAR LEAKS OCCURRED AFTER STENT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692596 INTRASTENT LD MEGA LD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR