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

Model Number FA-77450-16

Device Problem Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Takong, w., & kobkitsuksakul, c.(2020).Delayed proximal flow diverting stent migration in a ruptured intracranial aneurysm: a case report.  neurointervention,  15(3), 154¿157.Https://doi.Org/10.5469/neuroint.2020.00220.Medtronic received a literature article pertaining to a 38 year old man who presented with a headache.Ct and ct angiography scans of the brain showed acute subarachnoid hemorrhage at the basal cistern and left sylvian fissure, as well as a possible tiny aneurysm at the left supraclinoid internal carotid artery.Cerebral angiogram showed a small blister aneurysm at the medial aspect of the left supraclinoid internal carotid artery, with a width of 1.4mm and a neck of 1.3mm.Endovascular treatment using a pipeline was performed to cover the supraclinoid aneurysm due to challenges in clipping and coiling.Before it was reported that there was braid foreshortening during stent deployment.At that time, the largest available suitable flow diverter as well as an unsheathing and pushing technique to minimize the ¿accordion¿ effect was performed.However, the stent still covered the aneurysm neck, with the distal end of the stent located at 3 mm distal to the neck, which demonstrated contrast stagnation within the aneurysm during contrast injection.No postoperative complications occurred, and the patient was doing well.However, four weeks later, follow up ct angiography of the brain showed proximal stent migration.There was only 50% aneurysmal neck coverage.A slightly increased size of the aneurysm was detected as well.Two weeks later, repeated cerebral angiograms demonstrated further increased size of the aneurysm to 5.3mm wide and 5.1 mm height with a narrowing aneurysmal neck of 2.2 mm.Further foreshortening of the stent from 22.1mm to 19.8 mm in length was also.Intrasaccular coiling was then performed to resolve the issue and the procedure went well with the patient uneventfully discharged.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10999766
• MDR Text Key: 222283336
• Report Number: 2029214-2020-01294
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-77450-16
• Device Catalogue Number: FA-77450-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2020
• 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): Required Intervention
• Patient Age: 38 YR