MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number REACT-68

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

Patient Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Vasoconstriction (2126); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 05/02/2023

Event Type  Injury  

Event Description

Narloch j, piasecki a, ziecina p, debiec a, wierzbicki m, staszewski j and piasecki p (2023) is aspiration an effective acute stroke treatment in older adults? front.Neurol.14:1149531.Doi: 10.3389/fneur.2023.114953 medtronic literature review found a report of patient complications in association with react 68 and 71 catheters.The purpose of this article was to compare the clinical and angiographic outcomes of a direct aspiration first-pass technique in interventional stroke treatment for elderly patients compared with younger patients consecutive patients who underwent ¿a direct aspiration first-pass technique¿ (adapt) as the first choice of treatment for the treatment of stroke due to a large vessel occlusion between january 2016 and august 2021 at a comprehensive stroke center were included in the present study.A total of 162 patients (92 women and 70 men, aged between 35 and 94 years +/¿ 12.4 years) were included.To confirm the cerebral large-vessel occlusion (lvo), an impress diagnostic peripheral catheter (merit medical) was placed in an 8f radifocus super arrow-flex sheath introducer (arrow international inc.).The diagnostic catheter was exchanged for a guiding catheter, such as neuron max (penumbra, inc., alameda, ca, usa) or fubuki (terumo-microvention).The following aspiration catheters were used in this study: the react 68 and react 71 (medtronic); sofia and sofia plus (terumo-microvention); axs catalyst 5, 6, and 7 (stryker); or ace 68, jet7 (penumbra inc.).A microcatheter headway 0.021¿ (terumo-microvention) with 0.014¿ microwire traxcess (terumo, tokyo, japan) was used to reach the occlusion site.Aspiration passes were performed using adapt.The article does not state any technical issues during use of the react catheters the following intra- or post-procedural outcomes were noted: - 3 had complications in the 60 group, 17 in the =60 group, 5 in the 65 group, 15 in the =65 group, 13 in the 80 group, and 7 in the =80 group.- 7 had hemorrhage at 24 hours in the 60 group, 34 in the =60 group, 15 in the 65 group, 27 in the =65 group, 31 in the 80 group, and 11 in the =80 group.- 2 had sah in the 60 group, 8 in the =60 group, 2 in the 65 group, 8 in the =65 group, 4 in the 80 group, and 6 in the =80 group.- 1 had ich in the 60 group, 1 in the =60 group, 2 in the 65 group, 0 in the =65 group, 2 in the 80 group, and 0 in the =80 group.- 1 had vasospasm in the 60 group, 3 in the =60 group, 1 in the 65 group, 3 in the =65 group, 4 in the 80 group, and 0 in the =80 group.- 0 had embolization in a new territory in the 60 group, 11 in the =60 group, 3 in the 65 group, 8 in the =65 group, 9 in the 80 group, and 2 in the =80 group.- 0 had dissection in the 60 group, 4 in the =60 group, 0 in the 65 group, 4 in the =65 group, 3 in the 80 group, and 1 in the =80 group.- 7 didn't have mtici 2b-3 in the 60 group, 50 in the =60 group, 15 in the 65 group, 42 in the =65 group, 42 in the 80 group, and 15 in the =80 group.-mrs was 0 at discharge for 4 in the 60 group, 7 in the =60 group, 5 in the 65 group, 6 in the =65 group, 10 in the 80 group, and 1in the =80 group -mrs was 1 at discharge for 5 in the 60 group, 14 in the =60 group, 6 in the 65 group, 13 in the =65 group, 15 in the 80 group, and 4 in the =80 group -mrs was 2 at discharge for 4 in the 60 group, 17 in the =60 group, 9 in the 65 group, 12 in the =65 group, 19 in the 80 group, and 2 in the =80 group -mrs was 3 at discharge for 3 in the 60 group, 10 in the =60 group, 6 in the 65 group, 7 in the =65 group, 12 in the 80 group, and 1 in the =80 group -mrs was 4 at discharge for 1 in the 60 group, 11 in the =60 group, 2 in the 65 group, 10 in the =65 group, 8 in the 80 group, and 4 in the =80 group -mrs was 5 at discharge for 7 in the 60 group, 38 in the =60 group, 14 in the 65 group, 31 in the =65 group, 33 in the 80 group, and 12 in the =80 group -mrs was 6 at discharge for 5 in the 60 group, 30 in the =60 group, 9 in the 65 group, 26 in the =65 group, 26 in the 80 group, and 9 in the =80 group -mrs was 0 at 30 days for 3 in the 60 group, 8 in the =60 group, 4 in the 65 group, 7 in the =65 group, 9 in the 80 group, and 2 in the =80 group -mrs was 1 at 30 days for 6 in the 60 group, 9 in the =60 group, 6 in the 65 group, 9 in the =65 group, 14 in the 80 group, and 1in the =80 group -mrs was 2 at 30 days for 3 in the 60 group, 16 in the =60 group, 7 in the 65 group, 12 in the =65 group, 17 in the 80 group, and 2 in the =80 group -mrs was 3 at 30 days for 3 in the 60 group, 18 in the =60 group, 8 in the 65 group, 13 in the =65 group, 19 in the 80 group, and 2 in the =80 group -mrs was 4 at 30 days for 0 in the 60 group, 12 in the =60 group, 2 in the 65 group, 10 in the =65 group, 8 in the 80 group, and 4 in the =80 group -mrs was 5 at 30 days for 8 in the 60 group, 33 in the =60 group, 15 in the 65 group, 26 in the =65 group, 31 in the 80 group, and 10 in the =80 group -mrs was 6 at 30 days for 5 in the 60 group, 24 in the =60 group, 7 in the 65 group, 22 in the =65 group, 21 in the 80 group, and 8 in the =80 group -mrs was 0 at 90 days for 1 in the 60 group, 5 in the =60 group, 1 in the 65 group, 5 in the =65 group, 4 in the 80 group, and 2 in the =80 group -mrs was 1 at 90 days for 5 in the 60 group, 9 in the =60 group, 6 in the 65 group, 8 in the =65 group, 14 in the 80 group, and 0 in the =80 group -mrs was 2 at 90 days for 5 in the 60 group, 17 in the =60 group, 10 in the 65 group, 12 in the =65 group, 19 in the 80 group, and 3 in the =80 group -mrs was 3 at 90 days for 0 in the 60 group, 11 in the =60 group, 2 in the 65 group, 9 in the =65 group, 9 in the 80 group, and 2 in the =80 group -mrs was 4 at 90 days for 2 in the 60 group, 12 in the =60 group, 5 in the 65 group, 9 in the =65 group, 13 in the 80 group, and 1 in the =80 group -mrs was 5 at 90 days for 3 in the 60 group, 11 in the =60 group, 6 in the 65 group, 8 in the =65 group, 12 in the 80 group, and 2 in the =80 group -mrs was 6 at 90 days for 1 in the 60 group, 18 in the =60 group, 2 in the 65 group, 17 in the =65 group, 10 in the 80 group, and 9 in the =80 group -mrs was 0 at 12 months for 1 in the 60 group, 1 in the =60 group, 1 in the 65 group, 1 in the =65 group, 2 in the 80 group, and 0 in the =80 group -mrs was 1 at 12 months for 6 in the 60 group, 6 in the =60 group, 6 in the 65 group, 6 in the =65 group, 12 in the 80 group, and 0 in the =80 group -mrs was 2 at 12 months for 0 in the 60 group, 10 in the =60 group, 5 in the 65 group, 5 in the =65 group, 9 in the 80 group, and 1 in the =80 group -mrs was 3 at 12 months for 2 in the 60 group, 7 in the =60 group, 4 in the 65 group, 5 in the =65 group, 8 in the 80 group, and 1 in the =80 group -mrs was 4 at 12 months for 0 in the 60 group, 4 in the =60 group, 1 in the 65 group, 3 in the =65 group, 3 in the 80 group, and 1 in the =80 group -mrs was 5 at 12 months for 0 in the 60 group, 1 in the =60 group, 0 in the 65 group, 1 in the =65 group, 1 in the 80 group, and 0 in the =80 group -mrs was 6 at 12 months for 1 in the 60 group, 15 in the =60 group, 3 in the 65 group, 13 in the =65 group, 9 in the 80 group, and 7 in the =80 group.

Manufacturer Narrative

Continuation of d10: product id react-68 (unknown); implant date n/a; explant date n/a product id react-71 (unknown); implant date n/a; explant date n/a product id react-71 (unknown); implant date n/a; explant date n/a.G2: citation: authors: narloch j, piasecki a, ziecina p, d¸ebiec a, wierzbicki m, staszewski j and piasecki p.Is aspiration an effective acute stroke treatment in older adults?.Frontiers in neurology 2023.Doi: 10.3389/fneur.2023.114953 a.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

• Brand Name: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 19069369
• MDR Text Key: 339686721
• Report Number: 2029214-2024-00604
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K180715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Hospitalization; Disability
• Patient Sex: Female