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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Hematoma (1884); Neurological Deficit/Dysfunction (1982); Paresis (1998); Therapeutic Effects, Unexpected (2099); Thrombosis (2100); Vertigo (2134); Visual Impairment (2138); Hydrocephalus (3272)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Adam n. Wallace, thomas p. Madaelil, mudassar kamran, timothy r. Miller, josser e. Delgado almandoz, jonathan a. ,. Joshua w. Osbun. (2019). Pipeline embolization of vertebrobasilar aneurysms¿a multicenter case series. World neurosurgery, 124. Doi: 10. 1016/j. Wneu. 2018. 12. 116. Medtronic literature review found a report of patient complications after pipeline implantation. The purpose of the article was to examine the clinical and angiographic outcomes of patients with vertebrobasilar aneurysms treated with the pipeline embolization device (ped). The authors retrospectively reviewed the results of 35 patients with 37 vertebrobasilar aneurysms who underwent 36 treatment sessions with ped. Of the patients, 10 were male and 25 were female; mean age was 54. 1 years. The article describes the following post-procedure events - patient 15 ((b)(6) female) underwent ped placement in the treatment of a fusiform, vertebral pre-pica aneurysm with a size of 10 mm and length of 10 mm. The patient developed right hemiparesis on postoperative day 1 secondary to va ped thrombosis. One of their branch vessels, a large pica, was occluded. However, the patient recovered to a mrs score 1 by the 6-month follow-up examination. Patient 22 ((b)(6) male) underwent ped placement in the treatment of a fusiform, basilar trunk aneurysm with a size of 18. 1 mm and length of 18. 1 mm. The patient developed a right middle cerebellar peduncle perforator infarction on postoperative day 1 that resulted in diplopia, vertigo, and ataxia. However, the patient recovered to a mrs score 1 by the 6-month follow-up examination. Patient 10 ((b)(6) female) underwent ped placement in the treatment of a ruptured fusiform, basilar trunk aneurysm with a size of 8. 9 mm and length of 10 mm. The patient's treatment was complicated by fracture of the ped delivery guidewire, which was not retrieved but caused no clinical sequelae. Their aneurysm was initially treated with a single ped but had only decreased slightly in size at the 15-month follow-up examination. A second ped was subsequently placed, and no angiographic follow-up examination was obtained since the second procedure. Patient 29 ((b)(6) female) underwent ped placement in the treatment of a saccular, vertebral, pica origin aneurysm with a size of 10 mm and neck of 6 mm. The patient developed rectus sheath hematoma on postoperative day 2 that required a blood transfusion. Verifynow (accumetrics) testing at that time returned 12 prus. Clopidogrel was temporarily withheld until the prus were >60 and then resumed at a lower dose. Patient 4 ((b)(6) female) underwent ped placement in the treatment of a ruptured saccular, vertebral pre-pica aneurysm with size of 4. 9 mm and neck of 4. 9 mm. The patient developed hydrocephalus whom required external ventricular drainage; however, she did not experience any related bleeding complications. Patient 13 ((b)(6) female) underwent ped placement in the treatment of a ruptured fusiform, basilar trunk aneurysm with size of 8 mm and length of 9 mm. The patient developed hydrocephalus whom required external ventricular drainage; however, she did not experience any related bleeding complications.
 
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Brand NamePIPELINE 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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9151690
MDR Text Key166744828
Report Number2029214-2019-00983
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
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 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
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-REP
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 Received09/19/2019
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: 10/03/2019 Patient Sequence Number: 1
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