BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 11002629 · Received December 14, 2020

    Report

    Report Number
    2029214-2020-01295
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    June 20, 2020
    Report Date
    December 14, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED AGE OF 50 IS REPRESENTATIVE OF THE MEAN PATIENT AGE FOR ALL PATIENT INCLUDED IN THE LITERATURE ARTICLE STUDY. A3. THE REPORTED PATIENT GENDER OF "MALE" IS REPRESENTATIVE OF THE MAJORITY OF PATIENT IN THE LITERATURE ARTICLE STUDY (52%). A5B. THE PATIENT RACE "WHITE" IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS IN THE LITERATURE ARTICLE STUDY (72%). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    GRIFFIN, A., LERNER, E., ZUCHOWSKI, A., ZOMORODI, A., GONZALEZ, L.F., HAUCH, E.F. (2020). FLOW DIVERSION OF FUSIFORM INTRACRANIAL ANEURYSMS. NEUROSURGICAL REVIEW. HTTPS://DOI.ORG/10.1007/S10142-020-01332-0 ABSTRACT FUSIFORM ANEURYSMS ARE LESS COMMON THAN SACCULAR ANEURYSMS, BUT HAVE HIGHER ASSOCIATED MORTALITY AND REBLEEDING RATES. RECENTLY, FLOW DIVERSION HAS EMERGED AS A POSSIBLE TREATMENT OPTION. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE SAFETY AND EFFICACY OF THE PIPELINE EMBOLIZATION DEVICE (PED) FOR THE TREATMENT OF RUPTURED AND UNRUPTURED FUSIFORM ANEURYSMS. THIS WAS A RETROSPECTIVE ANALYSIS OF PATIENTS WITH FUSIFORM INTRACRANIAL ANEURYSMS TREATED WITH A PED AT A QUATERNARY CARE CENTER BETWEEN JANUARY 2012 AND SEPTEMBER 2019. OCCLUSION RATES, NEUROLOGIC MORBIDITY/MORTALITY, AND OTHER CLINICAL VARIABLES WERE ANALYZED. TWENTY-NINE PATIENTS WITH 30 FUSIFORM ANEURYSMS WERE TREATED WITH A PED. SIXTEEN ANEURYSMS (53%) WERE LOCATED IN THE ANTERIOR CIRCULATION AND 14 ANEURYSMS (47%) WERE IN THE POSTERIOR CIRCULATION. THE MEAN MAXIMAL DIAMETER OF THE ANEURYSMS WAS 10.1 ± 5.6 MM (RANGE 2.3¿25 MM). ANGIOGRAPHIC AND CLINICAL FOLLOW-UP WERE AVAILABLE FOR 28 ANEURYSMS (93%). THE MEDIAN FOLLOW-UP WAS 17.4 MONTHS (IQR 4.8 TO 28 MONTHS) AND OCCLUSION RATES WERE GRADED ACCORDING TO THE O¿KELLY-MAROTTA (OKM) SCALE. OF PATIENTS WITH DSA FOLLOW-UP, 15 ANEURYSMS (60%) WERE COMPLETELY OCCLUDED (OKM D) AND 19 ANEURYSMS (76%) HAD A FAVORABLE OCCLUSION RESULT (OKM C1-3 AND D). THE OVERALL COMPLICATION RATE WAS 26.7% WITH A NEUROLOGICAL MORBIDITY RATE OF 6.7% AND NEUROLOGICAL MORTALITY RATE OF 3.4%. FLOW DIVERSION CAN BE AN EFFECTIVE TREATMENT FOR BOTH RUPTURED AND UNRUPTURED FUSIFORM ANEURYSMS. NEVERTHELESS, COMPLETE OCCLUSION RATES ARE LOWER THAN FOR SACCULAR ANEURYSMS. THEREFORE, FLOW DIVERSION SHOULD BE CONSIDERED ONLY IF OTHER MORE DIRECT TREATMENT OPTIONS, SUCH AS CLIPPING OR STENT/COILING ARE NOT APPLICABLE. FLOW DIVERSION SHOULD BE USED CAUTIOUSLY IN PATIENTS PRESENTING WITH RUPTURE. IT WAS REPORTED THAT ALL PROCEDURES IN THE STUDY WERE TECHNICALLY SUCCESSFUL. NO DEVICE MALFUNCTIONS WERE REPORTED. 3 PATIENTS EXPERIENCED SERIOUS INJURY OR COMPLICATION RELATED EITHER TO THE DEVICE OR PROCEDURE. 1 PATIENT SUFFERED BRAINSTEM STROKE DUE TO ACUTE THROMBOSIS. 1 PATIENT EXPERIENCED BLINDNESS. ANOTHER PATIENT SUFFERED AN INTRAPARENCHYMAL HEMORRHAGE AFTER SECOND PROCEDURE TO PLACE A VENTRICULOPERITONEAL SHUNT 7 DAYS AFTER PLACEMENT OF THE PIPELINE; DUAL ANTIPLATELET TREATMENT (DAPT) HAD BEEN HELD AND THE PATIENT HAD TWO UNITS OF PLATELETS TRANSFUSED PRIOR TO THE SHUNT PLACEMENT PROCEDURE. THIS PATIENT MADE A FULL NEUROLOGICAL RECOVERY. 4 PATIENT'S REQUIRED RETREATMENT DUE TO PERSISTENT ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470775 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R| S