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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Nerve Damage (1979); Therapeutic Response, Decreased (2271)
Event Date 03/28/2020
Event Type  Injury  
Manufacturer Narrative
Event date: please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Refer to manufacturer report 2029214-2020-00995 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Ahmed, s. , hosseini, m. , santini, r. , sahajwani, s. , vallabhaneni, r. , toursavadkohi, s. , karwowski, j. , and nagarsheth, k. (2020) transcarotid endovascular repair of extracranial internal carotid artery aneurysms using flow reversal for distal embolic protection. Elsevier inc. Ann vasc surg. 67: 568. E13¿568. E18 doi. Org/10. 1016/j. Avsg. 2020. 03. 020. Medtronic literature review found reported of patient complications in association with the pipeline flex. The purpose of this article was to review 3 cases of distal extracranial internal carotid artery (ica) aneurysms treated with place ment of stent grafts by way of transcarotid approach and flow reversal for distal embolic protection. Only one patient was treated with a pipeline stent and the patient was an 83 year old male. The following intra- or post-procedural outcomes were noted: it was determined the first attempt at treatment was unsuccessful 6 months prior due to the significant tortuosity of the vessels, and the lack of trackability of the two pipeline devices from a transfemoral approach. Additionally, the pipeline stents were undersized for the vessel diameter in the case. The patient developed a hoarseness due to a left recurrent laryngeal nerve palsy from the aneurysm pulsation against the nerve. A computed tomography (ct) was performed which found incomplete exclusion of the previously treated aneurysm. The aneurysm was treated with other manufacturer's products, and post-procedure angiography demonstrated complete exclusion of the aneurysm and excellent flow into the distal ica. Patient was discharged on postoperative day 1 on dual antiplatelet therapy. The patient's hoarseness improved after the endovascular repair, and there were no other neurological symptoms.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key10624789
MDR Text Key209781411
Report Number2029214-2020-00996
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
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 10/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received09/17/2020
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: 10/04/2020 Patient Sequence Number: 1
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