BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHENOM

    MDR report key: 17703541 · Received September 7, 2023

    Report

    Report Number
    2029214-2023-01611
    Event Type
    Death
    Date Received
    September 7, 2023
    Date of Event
    December 30, 2022
    Report Date
    September 7, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    PMA / PMN Number
    K210230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: ZHANG, H., REN, J., WANG, J., & LV, X.. THE OFF-LABEL USES OF PIPELINE EMBOLIZATION DEVICE FOR COMPLEX CEREBRAL ANEURYSMS: MID-TERM FOLLOW-UP IN A SINGLE CENTER.. INTERVENTIONAL NEURORADIOLOGY¿: JOURNAL OF PERITHERAPEUTIC N 2022. DOI: 10.1177/15910199221148800 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. 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

    ZHANG H, REN J, WANG J, LV X. THE OFF-LABEL USES OF PIPELINE EMBOLIZATION DEVICE FOR COMPLEX CEREBRAL ANEURYSMS: MID-TERM FOLLOW-UP IN A SINGLE CENTER. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUR OSCIENCES. DECEMBER 2022:15910199221148800. DOI:10.1177/15910199221148800. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE PIPELINE EMBOLIZATION DEVICE (PED), NAVIEN CATHETER, AND MARKSMEN AND PHENOM CATHETER. THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE THE OFF-LABEL USES OF PIPELINE EMBOLIZATION DEVICE FOR A VARIETY OF TYPES OF ANEURYSMS INCLUDING RUPTURED ANEURYSMS, POSTERIOR CIRCULATION ANEURYSMS, SMALL ANEURYSMS, DISTAL ANEURYSMS, AND RECURRENT ANEURYSMS. BETWEEN JANUARY 2019 AND JANUARY 2022, ALL PATIENTS WITH THE OFF-LABEL USES OF THE PED FOR CEREBRAL ANEURYSMS IN THIS STUDY'S CENTER WERE INCLUDED IN THIS ANALYSIS. TREATMENTS WERE DEFINED AS OFF-LABEL IF THEY FELL OUT OF THE APPLICATIONS APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION AS OF 2021. IN THIS STUDY, 107 PATIENTS (63 FEMALE AND 44 MALE) WITH 121 ANEURYSMS MET THE INCLUSION CRITERIA, INCLUDING RUPTURED ANEURYSMS, PCAS, SMALL ANEURYSMS, DISTAL ANEURYSMS, AND RECURRENT ANEURYSMS. ALL CASES WERE NOT IDEAL CANDIDATES FOR CONVENTIONAL SURGICAL OR ENDOVASCULAR TECHNIQUES. THE PATIENT¿S AGE RANGED FROM 16 TO 81 YEARS, MEAN OF 54 YEARS. IN GENERAL, A LARGE DIAMETER 8-F GUIDE CATHETER (ENVOY, CORDIS, USA) WAS USED PROXIMALLY AND AN INTERMEDIATE SUPPORT CATHETER OF 5-OR 6-F (NAVIEN, MEDTRONIC, USA) WAS USED FOR ADDED SUPPORT. THE 0.027'' MICROCATHETER (USUALLY MARKSMAN (MEDTRONIC, USA) WAS CHOSEN, OR PHENOM (MEDTRONIC, USA) WAS CHOSEN FOR A TORTUOUS APPROACH) WAS NAVIGATED PASSING THE ANEURYSM OVER A MICROWIRE WITH THE MICROCATHETER PLACED DISTALLY TO THE TARGET ANEURYSM. NEXT, THE MICROWIRE WAS REMOVED AND THE PED WAS LOADED INTO THE MICROCATHETER. THE CELLS OF THE DISTAL PORTION OF PED MUST BE FULLY EXPANDED. THIS IS USUALLY ACCOMPLISHED BY EXPOSING 10¿15 MM OF THE PED AND PUSHING THE WHOLE SYSTEM GENTLY. THE PED DEPLOYMENT PROCEEDED BY PUSHING THE PED DELIVERY WIRE GENTLY AND SLOWLY. THE PED WILL BE EXPANDED FORWARD WHILE THE MICROCATHETER WAS DRAWN BACK. DURING DEPLOYMENT OF THE PED, WALL APPOSITION WAS CONFIRMED BY ANGIOGRAPHY. IN RUPTURED ANEURYSMS, ADDITIONAL COILS MUST BE USED TO PROTECT THE ANEURYSM RERUPTURE. IN UNRUPTURED LARGE OR GIANT ANEURYSMS, COILS WERE USED TO PROMOTE THEIR OCCLUSION BUT WERE NOT MANDATORY. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE MEDTRONIC DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -SEVEN (6.5%) PATIENTS HAD BRAIN ISCHEMIA AFTER THE PROCEDURE WITH FOUR COMPLETE RECOVERIES AND THREE DEATHS AFTER INEFFECTIVE TREATMENT OF TIROFIBAN -ONE PATIENT HAD A SUBARACHNOID HEMORRHAGE AT THE SITE OF THE ANEURYSM (AICA) AT 6 DAYS AFTER THE PROCEDURE AND DIED. -IN PCA PATIENTS, ONLY TWO BASILAR APEX ANEURYSMS UNDERWENT PED TREATMENT, BOTH OF WHOM DIED OF THROMBOTIC COMPLICATIONS. -THE OVERALL RATE OF COMPLETE ANEURYSM OCCLUSION WAS 77.8% (28/36 IN 35 PATIENTS) FOR POSTERIOR CIRCULATION ANEURYSMS AND 95.3% (81/85 IN 72 PATIENTS) FOR ANTERIOR CIRCULATION ANEURYSMS. ANEURISMAL OCCLUSION INCOMPLETE IN 11 PATIENTS AND COMPLETE IN 96. AT FOLLOW-UP, 113 (93.4%) ANEURYSMS WERE COMPLETELY OCCLUDED, ONE HAD RESIDUAL NECK, AND SEVEN HAD RESIDUAL ANEURYSM FILLING. -SIX PATIENTS HAD ASYMPTOMATIC >50% IN-STENT STENOSIS, WHICH WAS MANAGED BY CONTINUING THE DUAL ANTIPLATELET REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926171 PHENOM CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-FG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death| O