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); Fistula (1862); Headache (1880); Intracranial Hemorrhage (1891); Ischemia (1942); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Visual Impairment (2138); Loss of Vision (2139); Visual Disturbances (2140); Rupture (2208)

Event Date 07/14/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Thomas w.Link, joseph a.Carnevale, jacob l.Goldberg, conor jones, gary kocharian, srikanth r.Boddu, ning lin, athos patsalides, y.Pierre gobin, jared knopman; journal of clinical neuroscience; 2021; 96, 129-135;multiple pipeline embolization devices improves aneurysm occlusion without increasing morbidity: a single center experience of 140 cases; :https://doi.Org/10.1016/j.Jocn.2021.01.0.Medtronic received information in a literature article that patient's treated with pipeline embolization device (ped) stents had complications.140 cases at one institution form 2012 to 2017 were retrospectively reviewed, and aneurysms treated with a single ped vs.Multiple were compared. the average maximal dome size was 6.9 ± 4.6 mm, with only 20 (14.3%) measuring >10 mm.Seventy-two (51.4%) were left-sided, and the majority arose from the supraclinoid internal carotid artery (ica).The locations included 8 (5.7%) cavernous ica, 25 (17.9%) ophthalmic, 41 (29.3%) paraophthalmic, 36 (25.7%) sh, 16 (11.4%) posterior communicating, 2 (1.4%) anterior choroidal, 7 (5.0%) ica side-wall, 1 (0.7%) anterior cerebral artery (aca), and 4 (2.9%) middle cerebral artery (mca).The majority of aneurysms were saccular (130 (92.9%)), with only 10 (7.1%) being fusiform or blister.A normal vessel arose from the neck of 38 (27.1%) and from the dome of 3 (2.1%).The average dome to neck ratio was 1.7. ped deployment was successful in all cases.A single device was used in 46 (32.9%), two peds were used in 76 (54.3%), and 3 were used in 18 (12.9%).Coils were used in the dome of the aneurysm in 7 (5.0%) cases.Patients treated earlier on were all maintained on aspirin and clopidogrel, andplatelet assays were obtained to ensure appropriate platelet inhibition.Ticagrelor was used more commonly in more recent patients, which does not require the use of platelet assays.All patients receiving ped were kept on dual antiplatelet therapy (dapt) (aspirin & clopidogrel, or aspirin & ticagrelor) until 6 month follow up angiography. pipeline classic device was used in earlier patients, while the pipeline flex device was used in more recent patients.  at 6 months, 113 (86.9%) aneurysms were completely occluded.At 1 year, 90 (91.8%) were occluded and at longest follow-up, 124 (97.6%).Of the 17 (13.1%) that were not occluded after 6 months, 7 (5.1%) required retreatment with an additional ped.Another 5 went on to become completely occluded after more time, and another 5 were left with small residual neck that is being observed conservatively without evidence of change.Of the 7 that required an additional ped, 6 were completely occluded at 6 month follow-up, and one is still pending a follow-up study. within 30 days of treatment, there were 2 (1.4%) major and 7 (5.0%) minor complications.After 30 days, there were an additional 1 (0.8%) major and 4 (3.1%) minor complications.There was 1 (0.7%) mortality.Major perioperative complications included a large intracerebral hemorrhage (ich) on the same side but remote from the aneurysm shortly after the procedure that lead to mortality, and a delayed rupture of a cavernousica aneurysm that presented 6 days after treatment with eye pain, proptosis, and new third and sixth cranial nerve palsies. minor perioperative complications included 4 ischemic events consisting of 2 transient episodes of weakness or numbness that resolved by discharge, with corresponding small areas of acute infarction on mri, 1 episode of infarction leading to permanent minor subjective weakness, and 1 symptomatic retinal artery occlusion described by the patient as a small gray spot in the visual field.The other 3 included an occipital ich causing a hemianopsia that eventually resolved, a carotid-cavernous fistula (ccf) caused by wire perforation during the procedure that required an additional 2 peds to be placed, with no clinical symptoms and complete occlusion on follow-upimaging, and an asymptomatic stent occlusion found 10 days post-op on workup for headaches.The one major complication at greater than 30 days was a thrombotic stroke that occurred in the setting of a patient being non-compliant with clopidogrel that resulted in hemiparesis, which eventually improved to an mrs of 2.The minor complications after 30 days included 3 episodes of visual disturbances (amaurosis fugax, bright spots in visual field) shortly after clopidogrel was discontinued, which resolved upon restarting clopidogrel, and one episode of blindness in one eye that occurred a year after treatment in a patient that initially presented with declining vision in that eye.

• 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: 13596659
• MDR Text Key: 286108384
• Report Number: 2029214-2022-00300
• 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: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Date Device Manufactured: 03/27/2021
• 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): Death
• Patient Age: 54 YR
• Patient Sex: Female