MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number	PED3-027-550-16
Medical Device Problem Codes	Collapse (1099); Migration (4003)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Muscle Weakness/Atrophy (1967); Paresis (1998); Vascular Dissection (3160); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a patient who had post-procedure migration of the implanted pipeline vantage stent and experienced stroke/neurological symptoms.The patient had a pipeline vantage flow diversion stent implanted to treat a right internal carotid artery (ica) unruptured saccular aneurysm.The aneurysm max diameter was 5.5mm.The distal landing zone was 3.9mm and the proximal landing zone was 4.8mm.Vessel tortuosity was moderate.It was reported that the pipeline and all accessory devices were prepared per the instructions for use (ifu).The pipeline was delivered and deployed with noted good apposition and aneurysm coverage.The pipeline was implanted at the intended location and full wall apposition was achieved.The ophthalmic and posterior communicating (pcom) side branches were intentionally or knowingly covered as well at time of the pipeline deployment.Post-procedure the patient had neurological stroke symptoms demonstrated by left side weakness.The patient was given integrilin and improved but still did not return to baseline status.Computed tomography (ct) showed pipeline migration into the mca.Angiogram was performed and confirmed the ct finding of pipeline migration into the mca; the proximal part of the pipeline was barely covering the aneurysm and in addition to the ophthalmic and pcom segment, the anterior choroidal and anterior cerebral artery (aca) were covered after the stent migration.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported after implantation of the pipeline three runs of contrast were done to confirm pipeline location and apposition.All of these showed good apposition and proper location of the device.10 minutes after the procedure, the patient awoke and experienced inability to move right side extremities.Cta showed displacement and migration of the pipeline vantage into the right m1 ica segment.Imaging revealed thrombus formation in the lumen of the pipeline device.A bolus of integrilin and a subsequent infusion of this medication was initiated.A repeat physical exam revealed an improvement of the left hemiparesis.A repeat angiogram showed a distal migration of the pipeline towards the distal cavernous segment, both portions of the device, distal and proximal migrated.The proximal end of the device coverage of the neck of the aneurysm was minimal and around 1-3mm.A small residual thrombus was observed within the device and there was good flow in the carotid.For these reasons, it was decided that it was best to leave the device alone.It was thought that any small thrombus around the device would lyse due to the patient's antiplatelet regimen.At around 10:30pm the attending icu communicated that the patient became somnolent.Patient went back for a ct scan and a large right basial hemorrhage was found with extension into the ventricular system.A cta revealed a patent stent and patent intracranial vasculature, no new thrombotic event.Case was discussed with neurosurgeon and craniectomy was discussed but was determined to be too risky.Case was discussed with the family, and it was decided to not perform further surgery and after repeat imaging and further discussion, the patient was moved to comfort care.It was noted that there was no vasospasm.The patient had no known metal allergies or any known allergies at all.The positioning of the device was the same as the working projections.The cause of the migration was not confirmed.However, the physician reported that the pipeline vantage stent migrated a distance and around a 90 degree curve in the vessel which was unusual and thought there must be some collapse to allow a stent that appeared to be well apposed to migrate significantly.The pipeline had not been resheathed and only minimal manipulation; delivery and opening of the pipeline had been remarkably smooth.The physician believed the cause of the thrombosis was due to the pipeline migrating, possibly dragging and injuring the vessel.The doctor also noted that the length of the stent should have been good and the treatment and use of the pipeline were per the device labeling.
Additional Manufacturer Narrative
Update to h6 coding.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported that the patient developed symptoms 60-90 minutes after the procedure.

• Brand Name: PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
• Common Device Name: LASER THERAPY PRODUCT
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20352069
• Report Number: 2029214-2024-01744
• Device Sequence Number: 7999960
• Product Code: OUT
• UDI-Device Identifier: 00847536037007
• UDI-Public: 00847536037007
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED3-027-550-16
• Device Catalogue Number: PED3-027-550-16
• Device Lot Number: B720913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: Not provided; 10/18/2024; 10/24/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/14/2024; 10/21/2024; 11/18/2024
• Date Device Manufactured: 04/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Disability; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG