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

Model Number NV UNK PIPELINE

Device Problem Unintended Movement (3026)

Patient Problems Paralysis (1997); Dysphasia (2195)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Keisuke sasaki, naoto kimura, michiko yokosawa, ryosuke doijiri, ken takahashi, takayuki sugawara, & teiji tominaga.(2020).Use of contralateral trans-anterior communicating artery snare to rescue lost access to a pipeline embolization device unsheathed in an aneurysm.¿journal of neuroendovascular therapy,¿ 11, 508.Medtronic received a literature article in which the aim was to present pipeline related complication and its rescue strategy in use of vascular construction to treat large internal carotid artery aneurysms.In this case a (b)(6) female with a left ica aneurysm measuring 15mm in diameter was treated.The patient's presenting conditions include incomplete paralysis of the left oculomotor nerve.It was reported that, while collecting a delivery wire from the marksman, it interfered with the ped and the system migrated to the distal side, with intra-aneurysmal migration of the proximal side of the ped.It was impossible to enter the true lumen of the ped from the proximal side because the orifice of the stent faced the aneurysmal wall.Contralateral trans-acoma access to the ped was obtained through the distal ica.The microwire from the distal ica was connected with goose neck snares from the proximal ica.Pulling the snares to the proximal side, the ped was straightened and distal access was regained.Another ped was deployed such that it overlapped with the first ped to achieve vascular reconstruction.After awakening from general anesthesia, motor aphasia and paralysis of the right upper limb were noted.No high signal intensity suggestive of cerebral infarction was noted on magnetic resonance imaging diffusion-weighted imaging.The patient finally recovered from aphasia, but paralysis of the right upper limb remained after rehabilitation.The patient was referred to a rehabilitation hospital with a modified rankin scale score of 2.

Event Description

Additional information was received indicating that it was unknown whether the adverse event was directly caused by the product or the procedure.The patient¿s aneurysm itself has now disappeared and the condition is being continued to be followed by outpatient.Device information received: product id: ped2-375-20, lot number: a787916, product id: ped2-400-20, lot number: a833703.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12114614
• MDR Text Key: 261689464
• Report Number: 2029214-2021-00816
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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?: No
• Date Manufacturer Received: 11/09/2021
• 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: 49 YR
• Patient Sex: Female