BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 17628194 · Received August 25, 2023

    Report

    Report Number
    2029214-2023-01500
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    April 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE; G2: CITATION: AUTHORS: YOU, W., LV, J., LI, Z., CHEN, X., DENG, D., TANG, Y., LI, Y., SUN, Y., JIANG, Y. THE INCIDENCE AND PREDICTORS OF IN-STENT STENOSIS AFTER PIPELINE FLOW-DIVERTER STENTING FOR INTRACRANIAL ANEURYSM TREATMENT. FRONTIERS IN NEUROLOGY 14:1140497 2023. DOI:10.3389 / FNEUR.2023.1140497. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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

    YOU W, LV J, LI Z, ET AL. THE INCIDENCE AND PREDICTORS OF IN-STENT STENOSIS AFTER PIPELINE FLOW-DIVERTER STENTING FOR INTRACRANIAL ANEURYSM TREATMENT. FRONTIERS IN NEUROLOGY. 2023;14:1140497. DOI:10.3389/FNEUR.2023.1140497. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE PIPELINE EMBOLIZATION DEVICES (PED). THE PURPOSE OF THIS ARTICLE WAS TO DETERMINE THE INCIDENCE OF IN-STENT STENOSIS (ISS) AND IDENTIFY THE FACTORS THAT PREDICT ITS SEVERITY VIA THE USE OF ORDINAL LOGISTIC REGRESSION. A TOTAL OF 240 PATIENTS (MEAN AGE: 50.9 YEARS; 157 WOMEN, 65.4%) WITH 252 ANEURYSMS TREATED IN 252 PROCEDURES WERE ENROLLED IN THIS STUDY. ALL PED IMPLANTATIONS WERE PERFORMED UNDER GENERAL ANESTHESIA VIA A FEMORAL APPROACH. ACCORDING TO THE ANEURYSM ANATOMY AND THE OPERATOR¿S EXPERIENCE, THE TREATMENT STRATEGY WAS FORMULATED BASED ON THE DECISION OF WHETHER PED ALONE OR PED PLUS COILING WOULD BE USED. IN TOTAL, 140 PROCEDURES WERE PERFORMED WITH THE PIPELINE FLEX EMBOLIZATION DEVICE, WHILE THE REMAINING WERE PERFORMED USING THE PIPELINE CLASSIC EMBOLIZATION DEVICE. OF THE 252 PROCEDURES, 133 WERE TREATED USING PED ALONE, AND 119 WERE TREATED USING A COMBINATION OF PED AND COILING. PED WAS DEPLOYED SUCCESSFULLY IN ALL PATIENTS. MULTIPLE PED IMPLANTATIONS WERE PERFORMED IN 43 PROCEDURES, AND BALLOON ANGIOPLASTY WAS ADMINISTERED IN 52 PROCEDURES. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PED. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -AT THE LAST ANGIOGRAPHIC FOLLOW-UP EXAMINATION, COMPLETE ANEURYSM OCCLUSION WAS OBSERVED IN 213 CASES (84.5%). -PERIPROCEDURAL ISCHEMIC COMPLICATIONS (PERIPROCEDURAL STROKE OR TRANSIENT ISCHEMIC ATTACKS) AND HEMORRHAGE COMPLICATIONS WERE 2.8% (7/252) AND 0.8% (2/252). -TRANSIENT DEFICITS WERE OBSERVED IN 8 (3.2%) CASES, AND PERMANENT DEFICITS (MRS > 2) WERE OBSERVED IN 4 (1.6%) CASES. THERE WERE NO CASES OF PERIPROCEDURAL MORTALITY. -IN-STENT STENOSIS WAS DETECTED IN 135 LESIONS. ISS WAS MILD IN 66 CASES, MODERATE IN 52 CASES, AND SEVERE IN 17 CASES. WHILE MOST CASES WERE ASYMPTOMATIC, SYMPTOMATIC STENOSIS WAS IDENTIFIED IN TWO CASES. ONE PATIENT WHO WAS TREATED FOR A RIGHT CAROTID ARTERY ANEURYSM WITH 65% STENOSIS AT THE 3-MONTH FOLLOW-UP SHOWED LEFT HEMIPLEGIA, WHICH WAS CAUSED BY A RIGHT CEREBRAL INFARCTION 10 MONTHS AFTER TREATMENT; SYMPTOMS OF THE INFARCTION WERE RELIEVED BY THROMBOLYSIS AT THE LOCAL HOSPITAL. THE STENOSIS, IN THIS CASE, HAD AGGRAVATED TO 90% BY THE 18-MONTH FOLLOW-UP AND WAS SUBSEQUENTLY TREATED BY VASCULAR BYPASS BETWEEN THE SUPERFICIAL TEMPORAL ARTERY AND THE MIDDLE CEREBRAL ARTERY. THE OTHER PATIENT HAD A LEFT MIDDLE CEREBRAL ANEURYSM AND SUDDENLY SHOWED COMBINED APHASIA, WHICH WAS CAUSED BY 95% STENOSIS ACCOMPANIED BY STENT THROMBOSIS AT THE 6-MONTH FOLLOW-UP. THE PATIENT¿S SYMPTOMS RESOLVED, AND 80% STENOSIS REMAINED AFTER FURTHER TREATMENT WITH BALLOON ANGIOPLASTY AND STENT THROMBECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931543 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Disability| R SEE H10.