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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 Renal Failure (2041); Foreign Body In Patient (2687); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Swelling/ Edema (4577)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Moreno estébanez, a. , luna rodríguez, a. , pérez concha, t. , fernández maiztegi, c. , freijo guerrero, m. Del m. , díaz cuervo, i. , ugarriza serrano, i. , labayen azparren, i. , fondevila monso, j. , gil garcía, a. , manso del caño, x. , gonzález-pinto gonzález, t. , agirre beitia, g. , <(>&<)> gonzález díaz, e. (2021). Symptomatic intracranial embolic foreign-body reactions after endovascular neurointerventional procedures: a retrospective study in a tertiary hospital. Clinical neurology and neurosurgery, 200. Https://doi. Org/10. 10 16/j. Clineuro. 2020. 106323 medtronic review of the literature article found that a single facility review ofa total of 7446 neurointerventional procedures performed between 2013 and 2019, 11 cases were identified with an incidence of 0. 14 %. The procedures were therapeutic in all: ten aneurysm embolization/isolation, one acute ischemic stroke recanalization. Intracranial coils, stent or both were placed in all. Symptoms appeared during the following one day to fourteen months. Brain magnetic resonance imaging (mri) showed edematous, contrast-enhancing lesions scattered through the vascular territory of the canalized vessel. Brain biopsy confirmed the diagnosis in one case and was supportive in another one. Eight patients received immunosuppression. No treatment was started in two. After a median time of follow-up of 3. 5 years, five patients are totally asymptomatic. One patient presents slight weakness. Four patients have remote symptomatic seizures, but they had comorbid lesions (previous stroke, intracranial hemorrhage, biopsy needle-track¿s gliosis). Follow-up mri showed significant improvement in all the cases, with complete resolution in five. Non-symptomatic lesion fluctuation was observed in three cases. Two patients experienced symptomatic rebounds. It was unknown in the cases what devices was the origin of the potential polymers which were believed to cause the embolizations. The conclusion of the study was that intracranial embolic foreign-body symptomatic reactions are uncommon complications of neurointerventional procedures. Polymer-coats may peel-off the surface of catheters and devices during endovascular procedures and might lead to brain inflammatory foreign-body reactions. Diagnostic angiographies might have lower risk of polymer-embolization than therapeutic procedures. This entity¿s early recognition enables making proper diagnosis and treatment decisions. The cases included 4 procedures in which axium coils were used, including 1 patient who underwent a second coiling procedure. 1 patient, who underwent a coiling procedure with axium coils, had balloon assisted procedure with a hyperform balloon catheter; this patient also experienced focal seizures. 1 of the axium patient was lost to follow-up. The other two patients were treated with immunosuppressant anti-inflammatory medication and had complete resolution of the embolizations over time. 3 of the cases in the study were with patients who had pipelines implanted and 2 of these procedures also involved the use of a navien catheter. 2 of these patients had focal seizures and were treated with immunosuppressant anti-inflammatory medication; 1 of these patient developed acute renal failure related to the long-term medication treatment. One patient received no additional treatment and the embolization resolved completely over time.
 
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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 Key12069778
MDR Text Key265205470
Report Number2029214-2021-00779
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
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 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 Received06/14/2021
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

Patient Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
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