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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100)
Event Date 07/03/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Pressman, e. , de la garza, c. A. , chin, f. , fishbein, j. , waqas, m. , siddiqui, a. , snyder, k. , davies, j. M. , levy, e. , kan, p. , ren, z. , mokin, m. (2020). Medtronic literature review found reports of patient post-op complications following pipeline device implantation for aneurysm embol ization. The purpose of the article was to explore the frequency of "nuisance bleeding" occurring in patients who were treated with dual antiplatelet treatment following pipeline procedures. The authors reviewed 245 cases involving 243 patients in which aneurysms were treated with placement of a pipeline device for embolization treatment of an aneurysm. Aneurysm size varied from 1. 76 to 57mm. Of the 243 patients, the median age was 57. 57 years; 42 were male and 201 were female. The article does not state any technical issues during the pipeline procedures. The following post-procedure follow-up outcomes were noted: 15 patients experienced diagnosed alarming bleeding ("intracranial or life-threatening bleeding or that [required] blood transfusion"). 5 of the patients who experienced alarming bleeding were noted to have an ischemic complications following cessation of dapt. Of these 5 patients, 1 had a transient ischemic attack, 1 had an acute stroke, and three developed in-stent thromboses. (pli 10).
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10310647
MDR Text Key203824113
Report Number2029214-2020-00713
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-RPT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/22/2020 Patient Sequence Number: 1
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