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

Model Number NV UNK PIPELINE

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Nerve Damage (1979); Paralysis (1997); Dysphasia (2195); Hydrocephalus (3272)

Event Date 12/27/2021

Event Type  Injury  

Event Description

Huijian ge, xiheng chen, kai liu, yang zhao, longhui zhang, peng liu, yuhua jiang, hongwei he, ming lv, youxiang li; frontiers in neurology; 2022; 13 (843839); endovascular treatment of large or giant basilar artery aneurysms using the pipeline embolization device: complications and outcomes; doi: 10.3389/fneur.2022.843839.Medtronic received information in a literature article of patient's having complications with pipeline embolization devices (ped)s. 29 patients (18 men, 11 women) with large or giant basil artery (ba) aneurysms were retrospectively examined.Mean age was 44.1.The study describes the experience using the ped to treat these aneurysms.Retrospectively collected the data of consecutive patients with large or giant ba aneurysms who were electively treated using the ped at our center from january 2016 to october 2020.All patients received dual antiplatelet therapy (clopidogrel 75 mg/d and aspirin 100 mg/d) for at least 5 days before the procedure.A triaxial guide-catheter system using a 6-fr cook catheter (cook medical, bloomington, in, usa), 5-fr or 6-fr navien guiding catheter (medtronic), and marksman microcatheter was used to deploy the ped. periprocedural complications were defined as those that developed within 30 days of the procedure. favorable outcome was defined as mrs score less than or equal to 2; poor outcome was defined as score greater than 2. seventeen ba aneurysms were large and 12 were giant. mean aneurysm size was 22.2. fusiform aneurysms were more common (18 patients, 62.1%). fifteen ba aneurysms (51.7%) were classified as distal and 14 as proximal.Eight aneurysms (25.8%) presented with intraaneurysmal thrombus; two (cases 12 and 16) had been previously coiled and required retreatment because of recanalization. forty-one peds were implanted in the 29 patients.Adjunctive coiling or balloon placement was performed in 12 patients (41.4%). sufficient ped opening was achieved in all patients. complete occlusion was achieved in 17 aneurysms (74%) and near-complete occlusion in three (13%). periprocedural complications included ischemic stroke in five patients, worsening mass effect in three, and delayed cerebral hemorrhage in four.Among the ischemic strokes, four were perforator strokes and one was embolic.One case experienced acute onset dysarthria and right hemiplegia 12 hours after placement of four peds.Ct and mri showed a large brainstem infarct with no hemorrhage.After a 24-h tirofiban infusion, the patient¿s symptoms gradually resolved.However, on postprocedure day 3, headache and vomiting developed, which rapidly progressed to loss of consciousness, cardiorespiratory arrest, and death. delayed aneurysmal rupture was the presumed cause of death.Other cases recovered completely but 2 cases had mild residual single-limb paresis. three patients with giant aneurysms experienced worsened mass effect after treatment; all presented with initial symptoms of brainstem compression.2 cases experienced abducens nerve palsy after the procedure; however, mri did not show an infarction.Another case developed dyspnea because of aneurysmal brainstem compression after treatment and maintained a tracheotomy until he died of severe pulmonary infection 11months later. in the perioperative period, four patients with aneurysm size ranging from 22 to 40 mm developed fatal subarachnoid hemorrhage. in-stent thrombosis occurred in four patients.Angiography after thrombectomy revealed that these aneurysms were not completely occluded. at last follow-up, 2 of those cases had mrs scores of 4 and 3, while cases the other 2 died a short time after thrombectomy.To summarize twenty one patients (72.4%) achieved a favorable clinical outcomes. nine patients (31%) experienced a poor clinical outcomes, including two patients with severe disability and seven patients who died.Overall rates of morbidity and mortality were 10.3 and 24.2%, respectively.The main causes of death were delayed aneurysmal rupture (n = 4), in-stent thrombosis (n=2) and worsened mass effect (n=1).

Manufacturer Narrative

Event related to 2029214-2022-00403.If information is provided in the future, a supplemental report will be issued.

• 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: 13894745
• MDR Text Key: 293162096
• Report Number: 2029214-2022-00476
• Device Sequence Number: 1
• Product Code: OUT
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Date Manufacturer Received: 03/09/2022
• 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: 44 YR
• Patient Sex: Male