BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 18349015 · Received December 18, 2023

    Report

    Report Number
    2029214-2023-02397
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    August 14, 2022
    Report Date
    December 18, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: CHARATE, R., AHMED, A., DELLA ROCCA, D. G., BLOOM, S., GARG, J., POTHINENI, N. V. K., DIBIASE, L., TURAGAM, M., GOPINATHANNAIR, R., HORTON, R., KAR, S., FONTANA, G., DOSHI, S. K., SWARUP, V., FINN, A.. EVALUATION OF MULTIMODALITY LAA LEAK CLOSURE METHODS FOLLOWING INCOMPLETE OCCLUSION: THE LAA LEAK STUDY.. JACC: CARDIOVASCULAR INTERVENTIONS 15(21):2158-2170 2022. HTTPS:/ /DOI.ORG/10.1016/J.JCIN.2022.08.0 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    CHARATE R, AHMED A, DELLA ROCCA DG, ET AL. EVALUATION OF MULTIMODALITY LAA LEAK CLOSURE METHODS FOLLOWING INCOMPLETE OCCLUSION: THE LAA LEAK STUDY. JACC: CARDIOVASCULAR INTERVENTIONS. 2022;15(21):2158-2170. DOI:10.1016/J.JCIN.2022.08.034 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF CARDIAC TAMPONADE IN ASSOCIATION WITH CONCERTO COIL EMBOLIZATION FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS 3 DIFFERENT CLOSURE TECHNIQUES FOR PERSISTENT PERIDEVICE LEAKS AFTER INCOMPLETE LAA CLOSURE AND COMPARE THEIR EFFICACY AND SAFETY OUTCOMES. THE AUTHORS REVIEWED 160 CASES OF PATIENTS TREATED FOR PERIDEVICE LEAK AFTER INCOMPLETE LAA CLOSURE USING ONE OF THE FOLLOWING: CONCERTO COIL EMBOLIZATION, VASCULAR PLUG OR SEPTAL OCCLUDERS, OR RADIOFREQUENCY ABLATION. OF THE 160 PATIENTS, 64 PATIENTS UNDERWENT COIL EMBOLIZATION. OF THE 160 PATIENTS, THE AVERAGE AGE WAS 72 YEARS, 46 WERE FEMALE AND 114 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE CONCERTO COILS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: TWO PATIENTS EXPERIENCED CARDIAC TAMPONADE REQUIRED LESS THAN 24 HOURS OF PERICARDIAL DRAINAGE AND NO ADDITIONAL CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67428 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O| R