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

Model Number NV UNK PIPELINE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Muscle Weakness (1967); Occlusion (1984); Visual Disturbances (2140); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Enriquez-marulanda a, salem mm, ascanio lc, et al.No differences in effectiveness and safety between pipeline embolization device and stent-assisted coiling for the treatment of communicating segment internal carotid artery aneurysms. the neuroradiology journal.2019;32(5):344-352.Doi:10.1177/1971400919845368.The aim of this study is to analyze pipeline angiographic and functional outcomes, and procedural complications.The average age was 61 years old, 80.1% female.21 patients in total were implanted with a pipeline device.Complete occlusion was achieved in 71.4% of the procedures, and there were three patients who required retreatment with an additional pipeline placement.It was reported that one patient had extravasation intra-procedurally, which was controlled with onyx and an external ventricular drain (evd).However, this patient suffered a second frontal hemorrhage on removal of the evd but made a complete recovery.A second patient had a right occipital hemorrhage with transient visual disturbance 23 days post procedure, which resolved.A third patient presented with an acute subdural hematoma 1 day following implant, which was treated with urgent craniotomy.Post-operative complete occlusion of the ica occurred, while off antiplatelet therapy, but the patient underwent successful emergent thrombectomy.The patient suffered persistent aphasia and right sided weakness.The final patient was noted to have an intraprocedure thrombosis which was treated with eptifibatide, heparin, and a balloon assisted technique.On post-operative day 1, the patient presented with anomia and right monoparesis which progressively improved until discharge leaving persistent mild residual weakness.In total for the pipeline group there were three intracranial hemorrhagic complications, two thromboembolic complications, and four other procedural related complications.

• Brand Name: PIPELINE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9856581
• MDR Text Key: 193407172
• Report Number: 2029214-2020-00261
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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): Other; Required Intervention
• Patient Age: 61 YR