BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 19210284 · Received April 29, 2024

    Report

    Report Number
    2029214-2024-00794
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    July 21, 2023
    Report Date
    April 29, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NV UNK PIPELINE (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-MARKSMAN (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-FG (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: SUNOHARA T, IMAMURA H, OHTA T, KOYANAGI M, GOTO M, FUKUMITSU R, FUKUI N, TAKANO Y, MATSUOKA Y, TERANISHI K, NARAMOTO Y, YAMAMOTO Y, NISHII R, SAKAI C, & SAKAI N. PIPELINE EMBOLIZATION DEVICE DYNAMICS: PREDICTION OF INCOMPLETE OCCLUSION BY ELONGATION FROM NOMINAL LENGTH. JOURNAL OF NEUROSURGERY 140(1):172-182 2023. DOI:10.3171/2023.5.JNS222403 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    SUNOHARA T, IMAMURA H, OHTA T, ET AL. PIPELINE EMBOLIZATION DEVICE DYNAMICS: PREDICTION OF INCOMPLETE OCCLUSION BY ELONGATION FROM NOMINAL LENGTH. JOURNAL OF NEUROSURGERY. 2023;140(1):172-182. DOI:10.3171/2023.5.JNS222403 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE (PED). THE PURPOSE OF THIS ARTICLE WAS TO STUDY FACTORS THAT LEAD TO INCOMPLETE OCCLUSION FOLLOWING PED IMPLANT. THERE WERE 46 PATIENTS INCLUDED IN THE STUDY. A COMBINATION OF PIPELINE FLEX AND PIPELINE FLEX W/ SHIELD TECHNOLOGY (36 PIPELINE FLEX, 9 PIPELINE SHIELD) WERE USED TO TREAT 47 ANEURYSMS. IT WAS NOTED THAT NAVIEN, MARKSMAN, AND PHENOM CATHETERS WERE USED IN THE PROCEDURES. THERE WERE NO INSTANCES OF MORTALITY OR PERMANENT MORBIDITY IN THE STUDY. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - TWO CASES WERE RE-TREATED WITH OVERLAPPING PED AFTERWARD AND COUNTED AS INCOMPLETE OCCLUSION.  - IT WAS NOTED THERE WERE 4 COMPLICATIONS OF SYMPTOMATIC EMBOLISM.  - AT 6-MONTH DSA, THE COMPLETE OCCLUSION RATE WAS 41% (19/47), AND THE PERCENTAGE AT THE FINAL FOLLOW-UP WAS 79% (37/47). THERE WERE 6 CASES OF PARTIAL OCCLUSION AT LAST FOLLOW-UP. OCCLUSION WAS CATEGORIZED AS COMPLETE (100%), NEAR COMPLETE (90%¿99%), AND PARTIAL (<(><<)> 90%) AT DSA OR MRA. BOTH NEAR-COMPLETE AND PARTIAL OCCLUSIONS WERE COLLECTIVELY DEFINED AS INCOMPLETE OCCLUSION. PED ELONGATION FROM THE NOMINAL LENGTH (IN MM) WAS SIGNIFICANTLY ASSOCIATED WITH INCOMPLETE OCCLUSION AT 6 MONTHS (COMPLETE OCCLUSION: 5.3 ± 4.2 MM VS INCOMPLETE OCCLUSION: 10.5 ± 7.8 MM). JUST AFTER DEPLOYMENT, THE PED ELONGATED 8.5 ± 7.1 MM (136%) FROM THE NOMINAL LENGTH. SIX MONTHS LATER, THE ELONGATION SHRANK TO 5.4 ± 6.2 MM (123%). THUS, A 13% (BASED ON THE NOMINAL LENGTH) SHORTENING OF THE PED IN 6 MONTHS WAS OBSERVED. CHANGES IN THE PED LENGTH AND DIAMETER WERE OBSERVED EVEN AT 36 MONTHS AFTER DEPLOYMENT. THE AUTHORS NOTED THAT ELONGATION IS DETERMINED NOT ONLY BY THE ANATOMICAL STRUCTURE AROUND THE ANEURYSMS, BUT ALSO BY THE PARENT ARTERY. IT WAS STATED THAT IN CLINICAL PRACTICE AN OVERSIZED PED WAS UNAVOIDABLE, ESPECIALLY IN CASES OF GIANT ANEURYSMS, WHERE PARENT ARTERIES AROUND THE NECK OF ANEURYSMS ARE FLATTENED, WITH A SMALLER DIAMETER THAN THE DIAMETER OF THE NORMAL ARTERY AT THE LANDING ZONE OF THE PED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143267 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11...