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

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.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL 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 Key: 10916598
• MDR Text Key: 218631622
• Report Number: 2029214-2020-01200
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 11/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-300-20
• Device Catalogue Number: PED-300-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 34 YR