BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 15901500 · Received December 2, 2022

    Report

    Report Number
    2029214-2022-02032
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 13, 2022
    Report Date
    December 1, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Description of Event or Problem · 0

    KRISTIAN K. JENSEN, PETER BONDE, JAN H. STORKHOLM, SØREN T. HEERWAGEN, PETER N. LARSEN, JONAS EIBERG; JOURNAL OF SURGICAL CASE REPORTS; 2020; (12)1¿3; SPONTANEOUS INTESTINAL BLEEDING DUE TO PSEUDOANEURISM OF THE GASTRODUODENAL ARTERY: CASE REPORT OF A RARE COMPLICATION TO MEDIAN ARCUATE LIGAMENT SYNDROME; DOI: 10.1093/JSCR/RJAA507 MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL MIGRATED AFTER DEPLOYMENT.  A 40-YEAR-OLD MALE WAS ADMITTED TO THE DEPARTMENT OF SURGERY DUE TO SYNCOPE AND MELENA. INITIAL UPPER GASTROINTESTINAL ENDOSCOPY REVEALED A PULSATING DUODENAL HEMORRHAGE WHICH COULD NOT BE CONTROLLED ENDOSCOPICALLY, AND A LAPAROTOMY WITH DUODENOTOMY AND SURGICAL H EMOSTASIS OF A PULSATING MUCOSAL ARTERY WAS PERFORMED. THE PATIENT WAS DISCHARGED AFTER 3 DAYS, BUT READMITTED 6 DAYS POSTOPERATIVELY DUE HEMATEMESIS AND SYNCOPE. EMERGENCY IMAGING SHOWED STENOSIS AND POST-STENOTIC DILATATION OF CELIAC ARTERY (CA) AND AN ANEURYSM ON A JEJUNAL BRANCH ARTERY. THE PATIENT WAS CIRCULATORY STABLE AND TRANSFERRED TO A TERTIARY CENTER AND UNDERWENT SUCCESSFUL COILING OF THE GASTRODUODENAL ARTERY, GASTROEPIPLOIC ARTERY AND TWO PANCREATICODUODENAL ARTERIAL BRANCHES. ONE MONTH LATER AN ADDITIONAL P SEUDOANEURYSM ON THE PANCREATICODORSAL ARTERY WAS IDENTIFIED IN IMAGING.  FOR THE EMDOVASCULAR PROCEDURE ACCESS WAS OBTAINED THROUGH THE RIGHT COMMON FEMORAL ARTERY USING A 6.5 FR. STEERABLE SHEATH. SUBSEQUENTLY, USING A MICROCATHETER SYSTEM THE LARGEST OF THE TWO PANCREATICODUODENAL ARCADES WAS CATHETERIZED ALL THE WAY TO THE INFERIOR PANCREATICODUODENAL ARTERY, WHERE COILING WAS STARTED. DETACHABLE MICROCOILS (CONCERTO HELIX (MEDTRONIC) AND INTERLOCK18 (BOSTON SCIENTIFIC) WERE CHOSEN FOR INITIAL EMBOLIZATION BUT STILL DISLODGED DUE TO THE VERY HIGH IN FLOW IN THE ARTERY. THE COILS SETTLED FURTHER DOWNSTREAM IN THE RELEVANT ARCADE AND SLOWED THE FLOW, THEREBY ALLOWING FOR PRECISE DEPLOYMENT OF MORE DETACHABLE MICROCOILS IN THE INFERIOR PANCREATICODUODENAL ARTERY. BOTH ARCADES, THE FIRST FEW CENTIMETERS OF THE GASTROEPIPLOIC ARTERY AND THE GASTRODUODENAL ARTERY (UP TO THE COMMON HEPATIC ARTERY) WERE SUBSEQUENTLY EMBOLIZED USING MULTIPLE NONDETACHABLE MICROCOILS. FOR THE OPEN SURGICAL PROCEDURE A MIDLINE LAPAROTOMY WAS PERFORMED AND ADHESIOLYSIS PERFORMED AS NECESSARY. POSTOPERATIVE THE PATIENT WAS DISCHARGED ON THE THIRD POSTOPERATIVE DAY, BUT READMITTED 4 DAYS POSTOPERATIVELY DUE TO A MINOR ABDOMINAL WOUND DEHISCENCE, WHICH WAS SUTURED UNDER GENERAL ANESTHESIA. ON FOLLOW-UP COMPUTED TOMOGRAPHY THE ARTERIAL STENOSIS WAS REPEALED AND THE PSEUDOANEURYSM COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398778 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male