BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

    MDR report key: 8456163 · Received March 27, 2019

    Report

    Report Number
    2953200-2019-00412
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    October 24, 2018
    Report Date
    March 27, 2019
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; MULTICENTER EXPERIENCE WITH ENDOVASCULAR TREATMENT OF AORTIC COARCTATION IN ADULTS. YOUNG ERBEN, GUSTAVO S. ODERICH, HENCE J. M. VERHAGEN, MAARTEN WITSENBURG, ALLARD T. VAN DEN HOVEN, EIKE S. DEBUS, MD, TILO KÖLBEL, MD, FRANK R. ARKO III, GIOVANNI B. TORSELLO, GIOVANNI F. TORSELLO,PETER F. LAWRENCE, MICHAEL P. HARLANDER-LOCKE, MPHMICHAEL BACHARACH, MD, WILLIAM D. JORDAN JR, MARK K. ESKANDARI, AND DONALD J. HAGLER. J VASC SURG 2019 (69) ISSUE 3 HTTPS://DOI.ORG/10.1016/J.JVS.2018.06.209. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR ENDOVASCULAR TREATMENT OF AORTIC COARCTATIONS BETWEEN 1999 AND 2015. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE IA ENDOLEAK ABSTRACT OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE OUTCOMES OF ENDOVASCULAR TREATMENT OF AORTIC COARCTATION IN ADULTS. METHODS: CLINICAL DATA AND IMAGING STUDIES OF 93 CONSECUTIVE PATIENTS TREATED AT NINE INSTITUTIONS FROM 1999 TO 2015 WERE REVIEWED. WE INCLUDED NEWLY DIAGNOSED AORTIC COARCTATION (NCO), RECURRENT COARCTATION, AND ANEURYSMAL/PSEUDOANEURYSMAL DEGENERATION (ANE) AFTER PRIOR OPEN SURGICAL REPAIR (OSR) OF COARCTATION. PRIMARY END POINTS WERE MORBIDITY AND MORTALITY. SECONDARY END POINTS WERE STENT PATENCY AND FREEDOM FROM REINTERVENTION. RESULTS: THERE WERE 54 (58%) MALE AND 39 (42%) FEMALE PATIENTS WITH A MEAN AGE OF 44 ± 17 YEARS. THIRTY-TWO PATIENTS HAD NCO (MEAN AGE, 48 ± 16 YEARS) AND 61 HAD ENDOVASCULAR REINTERVENTIONS AFTER PRIOR OSR DURING CHILDHOOD (MEAN, 30 ± 17 YEARS AFTER INITIAL REPAIR), INCLUDING 50 PATIENTS (54%) WITH RECURRENT COARCTATION AND 11 (12%) WITH ANE. CLINICAL PRESENTATION INCLUDED ASYMPTOMATIC IN 31 PATIENTS (33%), DIFFICULT TO CONTROL HYPERTENSION IN 42 (45%), AND LOWER EXTREMITY CLAUDICATION IN 20 (22%). ENDOVASCULAR TREATMENT WAS PERFORMED USING BALLOON-EXPANDABLE COVERED STENTS IN 47 (51%) PATIENTS, STENT GRAFTS IN 36 (39%) PATIENTS, BALLOON-EXPANDABLE UNCOVERED STENTS IN 9 (10%) PATIENTS, AND PRIMARY ANGIOPLASTY IN 1 (1%) PATIENT. MEAN LESION LENGTH AND DIAMETER WERE 64.5 ± 50.6 MM AND 19.5 ± 6.7 MM, RESPECTIVELY. MEAN SYSTOLIC PRESSURE GRADIENT DECREASED FROM 24.0 ± 17.5 MM HG TO 4.4 ± 7.4 MM HG AFTER TREATMENT (P <(><<)> .001). COMPLICATIONS OCCURRED IN NINE (10%) PATIENTS, INCLUDING AORTIC DISSECTIONS IN THREE (3%) PATIENTS AND INTRAOPERATIVE RUPTURES IN TWO PATIENTS; TYPE IA ENDOLEAK, RENAL EMBOLUS, SPINAL HEADACHE, AND ACCESS SITE HEMORRHAGE OCCURRED IN ONE PATIENT EACH. THE AORTIC DISSECTIONS AND RUPTURES WERE TREATED SUCCESSFULLY BY DEPLOYING AN ADDITIONAL COVERED STENT PROXIMAL TO THE SITE OF DISSECTION OR RUPTURE. TWO PATIENTS DIED WITHIN 30 DAYS OF THE INDEX PROCEDURE. AFTER A MEAN FOLLOW-UP OF 3.2 ± 3.1 YEARS, NEARLY ALL PATIENTS (98%) WERE CLINICALLY IMPROVED AND ALL STENTS WERE PATENT. REINTERVENTION WAS NEEDED IN 10 (11%) PATIENTS. FREEDOM FROM RE INTERVENTION AT 5 YEARS WAS 85%. TWO ADDITIONAL PATIENTS DIED DURING FOLLOW-UP OF COARCTATION-RELATED CAUSES, INCLUDING RUPTURE OF AN INFECTED GRAFT AND VISCERAL ISCHEMIA. PATIENT SURVIVALAT 5 YEARS WAS 89%. CONCLUSIONS: ENDOVASCULAR REPAIR IS EFFECTIVE WITH AN ACCEPTABLE SAFETY PROFILE IN THE TREATMENT OF NCO AND POSTSURGICAL COMPLICATIONS OF COARCTATION AFTER INITIAL OSR. AORTIC RUPTURE IS AN INFREQUENT (2%) BUT DEVASTATING COMPLICATION WITH HIGH MORTALITY. BALLOON-EXPANDABLE COVERED STENTS ARE PREFERRED FOR NCO, WHEREAS STENT GRAFTS ARE USED FOR ANE. THE RATE OF REINTERVENTIONS IS ACCEPTABLE, WITH HIGH PROCEDURAL AND LONG-TERM CLINICAL SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248778 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR