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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 Problems Activation Failure (3270); Migration (4003)
Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2016
Event Type  malfunction  
Event Description
Kühn, a. L. , wakhloo, a. K. , gounis, m. J. , kan, p. , de macedo rodrigues, k. , lozano, j. D. , marosfoi, m. G. , perras, m. , brooks, c. , howk, m. C. , rex, d. E. , massari, f. , <(>&<)> puri, a. S. (2017). Use of self-expanding stents for better intracranial flow diverter wall apposition. Interventional neuroradiology¿: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences, 23(2), 129¿136. Https://doi. Org/10. 1177/1591019916681981 medtronic review of the literature article found described 5 cases in which pipeline devices were implanted for aneurysm treatment. In 3 of the cases wall apposition was inadequate. In 2 cases proximal migration occurred and was attributed to challenging patient anatomy. In all cases a non-medtronic self-expanding nitonol stents were subsequently deployed for improving wall apposition and jail the pipeline stents from further migration respectively. During one procedure, a clot developed after stent deployment and the patient was immediately treated successfully with glycoprotein iib/iiia inhibitor. One patient had the pipeline implanted to cover 2 aneurysms and during follow-up one of the aneurysm was noted to have "near complete occlusion. " no additional symptoms/issues, treatment, or complications were noted related to the incomplete aneurysm occlusion.
 
Manufacturer Narrative
Reported patient age is representative of the mean age of all patients included in the reported information in the literature article. Reported patient sex is representative of the majority of patients included in the literature article. 3/5 patients were female. If information is provided in the future, a supplemental report will be issued.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12439385
MDR Text Key281029497
Report Number2029214-2021-01124
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 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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 Received08/21/2021
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

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