BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 6749402 · Received July 27, 2017

    Report

    Report Number
    2953200-2017-01194
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    July 22, 2015
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: DATE OF JOURNAL ACCEPTANCE JOURNAL ARTICLE ENTITLED; DELAYED RETROGRADE ASCENDING AORTIC DISSECTION AFTER ENDOVASCULAR REPAIR OF DESCENDING DISSECTION. NIKOLA DOBRILOVIC, MD, BULENT ARSLAN, MD, WALTER J. MCCARTHY, MD, ROBERT J. MARCH, MD, ULKU C. TURBA, MD, LAUREN MICHALAK, MS, MAJA DELIBASIC, MD, AND JAISHANKAR RAMAN, MD, PHD DEPARTMENTS OF CARDIOVASCULAR AND THORACIC SURGERY, AND RADIOLOGY, RUSH UNIVERSITY MEDICAL CENTER, CHICAGO, ILLINOIS; ANN THORAC SURG 2016;101:2357¿8). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WE REPORT THE CASE OF A PATIENT WHO DEVELOPED DELAYED RETROGRADE ASCENDING AORTIC DISSECTION AFTER PREVIOUS ENDOVASCULAR REPAIR OF HER DESCENDING THORACIC AORTA. PREOPERATIVE COMPUTED TOMOGRAPHY IMAGING SPECIFICALLY HIGHLIGHTS THE INTERACTION OF ENDOGRAFT SPRINGS WITH THE DISSECTION FLAP AND SURROUNDING AORTIC TISSUES. INTRAOPERATIVE FINDINGS ARE PRESENTED FOR COMPARISON AND FURTHER DISCUSSION. THE PATIENT INITIALLY UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION THAT DEMONSTRATED AN EXPANDING FALSE LUMEN. A MEDTRONIC VASCULAR ((B)(4)) VALIANT 28 MM X 15 CM ENDOVASCULAR AORTIC STENT GRAFT HAD BEEN POSITIONED AT THE DISTAL EDGE OF THE SUBCLAVIAN ARTERY WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS. TWO MONTHS LATER, AT THE TIME OF ROUTINE OUTPATIENT FOLLOW-UP IMAGING, THE PATIENT WAS FOUND TO HAVE A TYPE A AORTIC DISSECTION. COMPUTED TOMOGRAPHY (CT) DEMONSTRATES DISSECTION INVOLVING THE ASCENDING AORTA, WITH EXTENSION PROXIMAL TO THE STENT. ATTENTION IS DRAWN TO THE INTERACTION BETWEEN THE LEADING STENT EDGE AND SURROUNDING TISSUES. SUPERIORLY, A BARE SPRING IS OBSERVED TO PROTRUDE OUT THROUGH THE AORTIC WALL AT THE BASE OF THE INNOMINATE ARTERY WHERE IT ORIGINATES FROM THE AORTA (CIRCLE). INFERIORLY, A BARE SPRING IS OBSERVED TO OCCUPY AN INTRALUMINAL POSITION ABUTTING THE INTIMAL FLAP (ARROW). BASED ON IMAGING FINDINGS AS PRESENTED ABOVE, THE PATIENT WAS ADMITTED DIRECTLY TO THE HOSPITAL AND THE CARDIAC SURGERY TEAM CONSULTED. THE PATIENT WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR REPAIR OF THE DISSECTED ASCENDING AORTA. SURGICAL APPROACH INCLUDED STERNOTOMY, AXILLARY ARTERY CANNULATION,AND MODERATE HYPOTHERMIA. INTRAOPERATIVE ANATOMY CORRESPONDED WELL TO FINDINGS SUGGESTED BY CT IMAGING. BARE SPRINGS ALONG THE SUPERIOR ASPECT OF THE PROXIMAL STENT EDGE PROTRUDED THROUGH THE AORTIC WALL. PROTRUSION HAD OCCURRED IN MULTIPLE LOCATIONS TO VARYING DEGREES AND WAS ACCOMPANIED BY SCAR TISSUE. THE TWO MOST SUPERIORLY LOCATED SPRINGS WERE VISIBLE IN THEIR ENTIRETY OUTSIDE OF THE AORTIC WALL. SPRINGS PROTRUDED TO A LESSER DEGREE (ONLY PARTIAL THICKNESS) AS DISTANCE INCREASED FROM THE SUPERIOR-MOST PORTION OF THE ARCH AORTA/STENT INTERFACE. THE APPEARANCE SEEMED MOST CONSISTENT WITH A MECHANISM OF GRADUAL EROSION. FULL SYSTEMIC HEPARINIZATION, ADMINISTERED FOR BYPASS, RESULTED IN ACTIVE BLEEDING FROM MULTIPLE SUCH SITES. THE MOST SIGNIFICANT SITE OF BLEEDING WAS THE ARCH AORTA AT THE ORIGIN OF THE INNOMINATE ARTERY. THE AORTA WAS OPENED, AND AN INTIMAL FLAP WAS IDENTIFIED. VIEWED FROM WITHIN THE AORTA, ANATOMY CONFIRMED MULTIPLE BARE SPRING EROSIONS THROUGH THE AORTIC WALL. BARE SPRINGS EXTENDING FROM THE GRAFT WERE EXCISED USING WIRE CUTTERS. THE REMAINING FREE EDGES OF THE GRAFT AND ARCH AORTA WERE TACKED DOWN USING MULTIPLE PLEDGETED MATTRESS SUTURES (BETWEEN THE INNOMINATE AND LEFT CAROTID ARTERIES). AORTIC CONTINUITY WAS REESTABLISHED USING A 24-MM DACRON SUPRA CORONARY TUBE GRAFT EXTENDING INTO THE MID ARCH WITH INNOMINATE ARTERY RE-IMPLANTATION. THE PATIENT RECOVERED WELL FROM THIS OPERATION BUT WOULD GO ON TO REQUIRE MULTIPLE SUPPLEMENTAL ENDOVASCULAR PROCEDURES OF THE DESCENDING/ABDOMINAL AORTA TO ADDRESS ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528825 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF2828C150TU

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention