BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARKSMAN

    MDR report key: 18367585 · Received December 20, 2023

    Report

    Report Number
    2029214-2023-02428
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    December 21, 2022
    Report Date
    December 20, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE (UNKNOWN); PRODUCT ID: UNK-NV-FG (UNKNOWN); G2: CITATION: AUTHORS: VRANIC, J. E., HARKER, P., STAPLETON, C. J., REGENHARDT, R. W., DMYTRIW, A. A., DORON, O. M., ALOTAIBI, N. M., LESLIE-MAZWI, T. M., GUPTA, R., BERGLAR, I. K., TAN, C. O., KOCH, M. J., RAYMOND, S. B.,. THE IMPACT OF DUAL ANTIPLATELET THERAPY DURATION ON UNRUPTURED ANEURYSM OCCLUSION AFTER FLOW DIVERSION: A MULTICENTER STUDY. JOURNAL OF COMPUTER ASSISTED TOMOGRAPHY. 2023. HTTPS://DOI.ORG/10.1097/RCT.000000000000. 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.

    Description of Event or Problem · 0

    VRANIC, J. E., HARKER, P., STAPLETON, C. J., REGENHARDT, R. W., DMYTRIW, A. A., DORON, O. M., ALOTAIBI, N. M., LESLIE-MAZWI, T. M., GUPTA, R., BERGLAR, I. K., TAN, C. O., KOCH, M. J., RAYMOND, S. B., MASCITELLI, J. R., PATTERSON, T. T., SEINFELD, J., WHITE, A., CASE, D., ROARK, C., ¿ PATEL, A. B. (2023). THE IMPACT OF DUAL ANTIPLATELET THERAPY DURATION ON UNRUPTURED ANEURYSM OCCLUSION AFTER FLOW DIVERSION: A MULTICENTER STUDY. JOURNAL OF COMPUTER ASSISTED TOMOGRAPHY. HTTPS://DOI.ORG/10.1097/RCT.0000000000001457. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF INTRACRANIAL HEMORRHAGE, ISCHEMIC STROKE, IN-STENT STENOSIS, TRANSIENT ISCHEMIC ATTACK (TIA), COMPRESSIVE NEUROPATHY, RETROPERITONEAL HEMATOMA, AND GROIN HEMATOMA IN ASSOCIATION WITH PIPELINE FLOW DIVERSION TREATMENT. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE IMPACT THAT THE TYPE AND DURATION OF DUAL ANTIPLATELET THERAPY (DAPT) HAS ON ANEURYSM OCCLUSION RATES AND IATROGENIC COMPLICATIONS AFTER FLOW DIVERSION.  THE AUTHORS REVIEWED 205 CASES OF PATIENTS TREATED FOR ANEURYSMS USING A SINGLE PIPELINE EMBOLIZATION DEVICE (PED) AND DAPT. OF THE 205 PATIENTS, THE AVERAGE AGE WAS 54 YEARS, WERE 177 FEMALE AND 28 WERE MALE. TWO GROUPS WERE FORMED TO TRIAL THE DURATION OF DAPT AND THE SIGNIFICANCE IT HAS ON ANEURYSM OCCLUSION POST PIPELINE PLACEMENT. ONE GROUP (151 PATIENTS) WERE GIVEN DAPT FOR LESS THAN 6 MONTHS POST PIPELINE PLACEMENT AND THE OTHER GROUP (54 PATIENTS) WERE GIVEN DAPT FOR MORE THAN 6 MONTHS POST PIPELINE PLACEMENT. OVERALL, THERE WAS A STATISTICAL SIGNIFICANT DIFFERENCE IN THE DURATION OF DAPT AND ANEURYSMAL OCCLUSION POST PIPELINE PLACEMENT. THE PATIENTS IN THE DAPT GIVEN FOR LONGER THAN 6 MONTHS WERE FOUND TO TAKE SIGNIFICANTLY LONGER TO OCCLUDE THE ANEURYSM OR NOT OCCLUDE THE ANEURYSM AT ALL. THEREFORE, THE AUTHORS RECOMMENDED TREATING FUTURE PATIENTS WITH DAPT FOR LESS THAN 6 MONTHS TO SUCCESSFULLY OCCLUDE THE ANEURYSM POST PIPELINE PLACEMENT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE, MARKSMAN CATHETER, OR PHENOM CATHETER. AT FOLLOW UP 26 A NEURYSMS REMAINED NONOCCLUDED. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: INTRACRANIAL HEMORRHAGE OCCURRED IN 5 CASES (4 IN DAPT 6 MONTH GROUP AND 1 IN DAPT >6 MONTH GROUP) ISCHEMIC STROKE OCCURRED IN 1 CASE (DAPT 6 MONTH GROUP) IN- STENT STENOSIS OCCURRED IN 2 CASES (1 IN EACH GROUP) TRANSIENT ISCHEMIC ATTACK IN 2 CASES (DAPT >6MONTH GROUP) COMPRESSIVE NEUROPATHY IN 1 CASE (DAPT >6 MONTH GROUP) RETROPERITONEAL HEMATOMA IN 3 CASES (DAPT 6 MONTH GROUP) GROIN HEMATOMA IN 2 CASES ( DAPT 6 MONTH GROUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106499 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-MARKSMAN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10.