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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-300-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Unspecified Nervous System Problem (4426)
Event Date 11/01/2020
Event Type  Death  
Manufacturer Narrative
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
I. Jonathan pomeraniec, panagiotis mastorakos, daniel raper, min s. Park, rerupture following flow diversion of a dissecting aneurysm of the vertebral artery: case report and review of the literature, world neurosurgery, volume 143, 2020, pages 171-179, issn 1878-8750, https://doi. Org/10. 1016/j. Wneu. 2020. 07. 149. Medtronic literature review found reported of patient complications in association with flow diversion of the aneurysm using overlapping pipelines. The article does not state any technical issues during use of the pipelines. The patient was a nonsmoking, (b)(6) male with a body mass index of 31. He had a remote history of dyslipidemia and intermittent pleuritic chest pain on low dose beta blocker. He experienced a sudden onset of holocephalic, severe headaches with subsequent progressive decline of mental status. Computed tomography of the head at presentation demonstrated diffuse subarachnoid hemorrhage predominately of the foramen magnum with extension into the prepontine cistern and fourth and lateral ventricles with attendant acute hydrocephalus and periventricular edema. The patient underwent flow diversion of the aneurysm using overlapping pipelines (ped) (3. 0 x 20 and 3. 25 x 20 mm). The aneurysm neck was well covered with the 2 overlapping devices. Angiography showed appropriate positioning of the stent construct with good apposition to the wall. Post-procedure day 2, the patient experienced a sudden decline in mental status, hypertension, tachycardia, hypotension. New intraventricular hemorrhage, subarachnoid hemorrhage, and left subdural hematoma was found. The patient had absent cough and gag reflex and corneal response, as well as no spontaneous respirations. The family withdrew care, and the patient passed on the third day after the initial aneurysm rupture.
 
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Brand NamePIPELINE FLEX
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 Key10916598
MDR Text Key218631622
Report Number2029214-2020-01200
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 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-300-20
Device Catalogue NumberPED-300-20
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 Received11/13/2020
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: 11/29/2020 Patient Sequence Number: 1
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