MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARATHON

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Post Operative Wound Infection (2446); Swelling/ Edema (4577)

Event Date 12/01/2018

Event Type  Death  

Event Description

Rikhtegar r, mosimann p, weber r, wallocha m, yamac e, mirza-aghazadeh-attari m, chapot r.Effectiveness of very low profile thrombectomy device in primary distal medium vessel occlusion, as rescue therapy after incomplete proximal recanalization or following iatrogenic thromboembolic events.Journal of neurointervent surgery.Jan 2021;13:1067¿1072.Doi: http://jnis.Bml.Com/.Medtronic literature review found reported of patient complications in association with thrombectomy.The purpose of this article was to report recent progress with smaller retrievers has expanded the ability to reach distal brain arteries.It was reported recanalization, bleeding complications and short-term clinical outcomes with the smallest currently known low profile thrombectomy device in patients with primary or secondary distal medium vessel occlusion (dmvo).The authors reviewed 115 cases of patients treated for mechanical thrombectomy (mt) in dmvo.Patients were stratified into three groups: primary isolated distal occlusion (n=34), secondary distal occlusion after mt of a proximal vessel occlusion (n=71), or during endovascular treatment of aneurysms or arteriovenous malformations (avms) (n=10).Of the 115 patients, the average age was 72 years, 63 were female and 52 were male.Overall, successful recanalization was achieved in 86 (74.7%) of the 115 patients.Prior ivt was equally used in patients with ais with and without successful recanalization.Of the 34 patients with a primary dmvo (group 1), successful recanalization was achieved in 24 (70.5%) patients.The most common clot location was m3.Median nihss score at admission and discharge was 7 and 3, respectively.Fifteen of the 34 patients (44.1%) had a good functional outcome at discharge from our institution.Four patients died in hospital.Seventy-one patients (group 2) had a dmvo after plvo thrombectomy or presented simultaneously with plvo and dmvo on the initial digital subtraction angiography after partial recanalization (spontaneous or after intravenous tissue plasminogen activator).Successful recanalization of such secondary dmvos was achieved in 52 patients (73.2%).The most common occlusion site was the m3 segment of the mca (48 patients, 67.6%).In seven patients, a dual retriever maneuver with a solitaire x retriever (medtronic) and tigertriever 13 device was necessary.In these cases, the solitaire and the tigertriever 13 device were placed in the larger and smaller division branch, respectively.Successful recanalization was achieved in four (57%) of these seven patients without peri-interventional complications.Median nihss at admission, after 24hours, and at discharge was 11, 8, and 5, respectively.A good functional outcome was observed in 28 of the 71 patients (39.4%) in the combined plvo/dmvo thrombectomy group.All patients with distal vessel thromboembolic complications during cerebral aneurysm or avm embolization (group 3) were successfully recanalized (10/10).The mostcommon clot location was m3 (80%).There were no deaths or thrombectomy-related morbidity.Symptomatic and asymptomatic intracranial hemorrhage on control brain imaging was observed in 8 (7.6%) and 19 (18.1%) of the 105 patients with ais, respectively, independently of prior use of ivt.Nineteen patients with ais (18.1%) died during their hospital stay.Mean age at death was 81.1±11.9 years (range 54¿99 years; 13 (68%) older than 80 years).The mean duration of intervention in the deceased patients with ais was 146±83.6min compared with 82.4±53.6 in stroke survivors.The difference was statistically significant.Only six of the 19 deceased patients with ais received ivt, the remainder having presented outside of the eligible time window.Two died due to a symptomatic brain hemorrhage, one having received prior ivt.The following intra- or post-procedural outcomes were noted: asymptomatic intracranial bleeding, symptomatic intraparenchymal bleeding, in-hospital mortality (causes: large infarction, failed mechanical thrombectomy, symptomatic ich, acute coronary syndrome with pulmonary edema, sepsis).

Manufacturer Narrative

See regulatory report # 2029214-2022-00269 for information previously reported related to the same event.Rikhtegar r, mosimann p, weber r, wallocha m, yamac e, mirza-aghazadeh-attari m, chapot r.Effectiveness of very low profile thrombectomy device in primary distal medium vessel occlusion, as rescue therapy after incomplete proximal recanalization or following iatrogenic thromboembolic events.Journal of neurointervent surgery.Jan 2021;13:1067¿1072.Doi: http://jnis.Bml.Com/.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 13582265
• MDR Text Key: 285980664
• Report Number: 2029214-2022-00270
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

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 Model Number: UNK-NV-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/22/2022
• 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): Death; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female