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

Model Number REACT-71

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

Patient Problems Intracranial Hemorrhage (1891); Visual Impairment (2138); Cognitive Changes (2551)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-solitaire (unknown); product id: unk-nv-fg (unknown); g2: citation: authors: inoue, s., fujita, a., kurihara, e., sasayama, t.Mechanical thrombectomy for acute paradoxical cerebral embolism due to pulmonary arteriovenous malformation: a case report and review of literature.Surgical neurology international 14:13 2023.Doi:10.25259/sni_987_2022.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.See manufacturer report#: 2029214-2023-01905 for another report from this article.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Inoue s, fujita a, kurihara e, sasayama t.Mechanical thrombectomy for acute paradoxical cerebral embolism due to pulmonary arteriovenous malformation: a case report and review of literature.Surgical neurology international.2023;14:13.Doi:10.25259/sni_987_2022.Medtronic literature review found a report of patient complications in association with solitaire stent retriever, react 71 catheter, and phenom 21 microcatheter.The purpose of this article was to report a case of acute occlusion of the middle cerebral artery (mca) due to pulmonary arteriovenous malformation (pavm), for which mechanical thrombectomy was performed and a good outcome was achieved.The article does not state any technical issues during use of the devices.The following intra- or post-procedural outcomes were noted:  - the patient presented with severe right hemiplegia with marked dysarthria.Imaging showed occlusion of the distal m1 segment of the left mca; however, neck mra showed no embolic source in the proximal vessels including the aortic arch.An electrocardiogram showed no evidence of atrial fibrillation.Chest ct showed a pavm in the s10 inferior lobe of the left lung.Thrombectomy was performed using a combined technique with a solitaire, and a 1-cm red thrombus was retrieved in one pass, resulting in complete recanalization.Immediately after treatment, the patient became conscious, and their severe right hemiplegia improved markedly.Head ct showed an intracerebral hematoma in the contralateral right temporal lobe, but no new abnormal findings were found on the treated side.On the next day of treatment, the left hemispatial neglect and the left homonymous hemianopsia became apparent, but there was no increase in the intracerebral hematoma, and the patient was managed conservatively.Head ct on day 9 showed no worsening of the hematoma, and edoxaban 30 mg was started on day 10.Head mri and mra on day 11 showed no evidence of recurrent stroke.Chest ct angiography on d ay 10 confirmed the diagnosis of pavm in the left lung s10.As it was considered that there was no other lesion except the pavm that could cause cerebral embolism, endovascular coil embolization of the pavm was performed on day 24 to prevent recurrent stroke.The patient¿s post-treatment course was uneventful.Their left homonymous hemianopsia and left hemispatial neglect remained but tended to improve.They were transferred for rehabilitation on day 46 without stroke recurrence (nihss 2, modified rankin scale 2).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information received that of the adverse events that were mentioned within the article, none of them related directly to medtronic devices/products.

• 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: 17848892
• MDR Text Key: 324659232
• Report Number: 2029214-2023-01906
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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 H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female