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

Model Number PED2-425-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Headache (1880); Hematoma (1884); Muscle Weakness (1967); Blurred Vision (2137)

Event Date 02/25/2022

Event Type  Injury  

Event Description

Medtronic received a report that a patient who was implanted with 3 pipeline devices experienced visual symptoms, headache, and muscle weakness.The patient was undergoing treatment for a saccular, side branch aneurysm located in the c6 segment of the left ica.The max diameter was 6.5mm, the dome height was 5.5mm, the dome width was 5.6mm, and the neck size was 3.7mm.All 3 pipelines were successfully implanted with complete neck coverage and wall apposition achieved, and there was significant stasis in the aneurysm post procedure.The ophthalmic side branch was covered by the devices.It was reported that patient experienced bilateral blurry vision immediately after a procedure.This improved the same night.The patient also experienced a severe headache (rated 6/10), with throbbing localized with the left frontal region occurring the same day as the procedure in the same region as the treated aneurysm.The headache was associated with photo/phonophobia, which was managed by oral medication.The next day they experienced visual field deficit, with some blurriness in the upper visual field of their left eye.This involved approximately 10% of the visual field which remained stable.The patient's right eye vision was normal, and there were no complaints of eye pain. the patient was scheduled to see their neuro-ophthalmologist for further evaluation.No further treatment was provided at this time, and the event had not recovered/resolved.The event resulted in new or worsening of neurological deficits that lasted for more than 24 hours, and was not the result of a device deficiency. the site assessed the event as probably related to the disease under study and the procedure, and not related to the device.Four days after the procedure the patient also experienced right hand grip weakness as well as a bruise in the right wrist, site of access angiography. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).

Manufacturer Narrative

(b)(6): see manufacturer report # 2029214-2022-00490 and 2029214-2022-00491 for the other pipelines involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there was no additional medical/surgical intervention for the visual field defect and grip weakness.The sponsor assessed the event as possibly related to the device.The adverse event was likely due to a small retinal ischemic defect that was improving.Per provided visit notes by neuro-ophthalmologist, on examination the patient had good acuities in both eyes, and was with no evidence of an optic neuropathy.Fundus photos showed retinal whitening inferior to the left disc, which corresponds with her formal fields with a superior field defect.Also, per note, the neuro-ophthalmologist expected the left superior field deficit will improve over time.The patient was scheduled for a follow up visit in 2 weeks along with fluorescein angiogram (which we did yet not receive source documents for it).For headache, the patient was prescribed gabapentin.Physical examination note: she was well-appearing, was alert and oriented.Attention span and concentration were normal.Speech, language, memory, and general knowledge were intact.Visual acuities were 20/20 in her right eye (no improvement with pinhole) and 20/25-1 in her left eye (no improvement with pinhole) at distance.At near, j1+ in either eye.Visual fields were full in the right eye, and with superior field cut in the left eye.She perceived 10/10 ishihara color plates correctly with each eye.Pupils\were with anisocoria, left pupil 1 mm larger than right, difference appears the same in light vs dark.Ocular ductions were full.There was no nystagmus.Saccades and pursuits were normal.Deep sulci bilaterally, with some ptosis bilaterally.Optic discs appeared with a whitish region below her left disc, right disc without pallor or swelling.On the remainder of the neurologic examination, facial sensation was intact.Face was symmetric and hearing was intact to finger rub.Palate and tongue were midline.Shoulder shrug was 5/5.Strength in the arms and legs was 5/5 without pronator drift.Muscle t ne was normal without spasticity.Reflexes were 2+ and symmetric.Finger to nose was intact without dysmetria.Sensation was normal to vibration, proprioception, and light touch.Gait was steady with a narrow base.

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.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that the clinical events committee (cec) adjudicated the retinal ischemic defect as a serious device, procedure, and therapy related adverse event.The adverse event was assessed as a minor stroke by cec committee.The cec assessed the worsening headache as a non-serious event with relationship to the study device and procedure.

Event Description

Additional information received reported that the patient recovered/resolved.

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 FLEX W/SHIELD TECHNOLOGY
• 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: 13912863
• MDR Text Key: 293366917
• Report Number: 2029214-2022-00492
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284411
• UDI-Public: 00763000284411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED2-425-12
• Device Catalogue Number: PED2-425-12
• Device Lot Number: B310455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Date Device Manufactured: 12/10/2021
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG