BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT BALLOON

    MDR report key: 6472867 · Received April 7, 2017

    Report

    Report Number
    2953200-2017-00551
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    April 20, 2016
    Report Date
    March 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: TWO CASES OF AORTIC INTIMAL INTUSSUSCEPTION DURING ENDOVASCULAR REPAIR OF AN ACUTE TYPE B DISSECTION. GEORGE E. HAVELKA, MD, TADAKI M. TOMITA, MD, S. CHRIS MALAISRIE, MD, KAREN J. HO, MD, AND MARK K. ESKANDARI, MD (2016, VOL. 23(3) 521¿528) A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 3.2 CM TYPE B THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE REQUIRED EMERGENT TEVAR. THE VALIANT DEVICE WAS IMPLANTED JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY. IT WAS NOTED THAT THE LEFT SUBCLAVIAN ARTERY WAS INTENTIONALLY COVERED. THE TRUE LUMEN FAILED TO EXPAND SUFFICIENTLY SO ANOTHER VALIANT DEVICE WAS IMPLANTED TO EXTEND DOWN TO THE CELIAC ARTERY. A REPEAT ANGIOGRAM REVEALED THAT THE DISTAL PORTION STENT GRAFT WAS SIGNIFICANTLY CONSTRAINED. A RELIANT BALLOON WAS USED TO GENTLY DILATE THE DISTAL PORTION OF THE SECOND STENT GRAFT AS WELL AS THE PORTION OVERLAPPING WITH THE FIRST. FOLLOW-UP FLUOROSCOPY DEMONSTRATED IMPROVED STENT GRAFT PATENCY, BUT THERE NOW APPEARED TO BE SLUGGISH FLOW THROUGH THE VISCERAL ARTERIES AND A NEW FILLING DEFECT IN THE AORTIC LUMEN. IMAGING CONFIRMED THE PRESENCE OF AN OCCLUDING SOFT TISSUE MASS IN THE LUMEN OF THE AORTA AT THE LEVEL OF THE VISCERAL ARTERIES, MOST LIKELY FROM DETACHMENT AND EMBOLIZATION OF THE INTIMAL FLAP. GIVEN THIS NEW FINDING, THE CASE WAS CONVERTED TO OPEN AORTIC SURGERY. FLOW WAS RESTORED AND THE PATIENT WAS SENT TO RECOVER IN STABLE CONDITION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. ABSTRACT PURPOSE: TO RAISE AWARENESS OF A PREVIOUSLY UNDESCRIBED COMPLICATION OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR AORTIC DISSECTION THAT CAN LEAD TO ACUTE AORTIC OCCLUSION AND TO HIGHLIGHT THAT EARLY RECOGNITION, EXCISION OF THE INTIMAL FLAP, AND OPEN AORTIC REPAIR CAN BE LIFESAVING. CASE REPORT: TWO PATIENTS UNDERWENT TEVAR FOR ACUTE TYPE B DISSECTIONS COMPLICATED BY ABDOMINAL MALPERFUSION SYNDROME. DURING STENT-GRAFT DEPLOYMENT, THE INTIMAL FLAP CIRCUMFERENTIALLY DETACHED FROM ITS ORIGIN PROXIMALLY WITH SUBSEQUENT INTUSSUSCEPTION, LEADING TO ACUTE AORTIC OCCLUSION. BOTH COMPLICATIONS WERE RECOGNIZED INTRAOPERATIVELY WITH IMMEDIATE CONVERSION TO OPEN AORTIC RECONSTRUCTION AND INTIMAL FLAP EXCISION. THE FIRST PATIENT REQUIRED AN INFRARENAL AORTOBI-ILIAC BYPASS, WHILE THE SECOND HAD AN OPEN AORTIC FENESTRATION AND BOVINE PERICARDIAL PATCH REPAIR OF THE AORTOTOMY. THEIR POSTOPERATIVE COURSES WERE UNEVENTFUL. FOLLOW-UP IMAGING REVEALED EXCELLENT STENT GRAFT APPROXIMATION WITHOUT ENDOLEAK AND THROMBOSIS OF THE FALSE LUMEN. CONCLUSION: AORTIC INTIMAL FLAP DETACHMENT AND INTUSSUSCEPTION IS A RARE BUT POTENTIALLY FATAL COMPLICATION OF TEVAR FOR ACUTE COMPLICATED AORTIC DISSECTION. QUICK DIAGNOSIS AND A LOW THRESHOLD FOR CONVERSION TO OPEN REPAIR ARE CRITICAL IN ACHIEVING A SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255562 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC IRELAND REL46

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention