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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Vasoconstriction (2126); Visual Impairment (2138); Visual Disturbances (2140); Dysphasia (2195)

Event Date 01/10/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information reporting that the patient underwent mechanical thrombectomy procedure (mt) on (b)(6) 2021 in which a solitaire x device and a react catheter were used.Follow-up computed tomography (ct) imaging showed hemorrhagic transformation.Core lab image review of ct images from (b)(6) 2021 at 1057 and 1404 determined there was subarachnoid hemorrhage (sah) and new acute ischemic infarction in primary unaffected vascular territory right mca -m2.Images from (b)(6) 2021 showed ph2 changes.It was noted that symptomatic hemorrhagic transformation resulted in patient death but was determined to be unrelated to the medtronic devices or the procedure.

Event Description

Additional information received reported that the patient was undergoing a mechanical thrombectomy on (b)(6) 2021 for an occlusion of the distal portion of m1 of the left middle cerebral artery (mca) with minimal distal flow of contrast (tici 1).Successful recanalization (tici 2c) was achieved after the first pass.The patient experienced vasospasm associated with the procedure and was treated with intra-atrial nimodipine 1g.The decision was made to end the procedure with no further incidents or complications.The patient's nihss score was 15 immediately following the procedure, and improved to 3 after 24 hours.On (b)(6) 2021 the patient develop hemiparesis and the inability to speak.Ct imaging showed a new occlusion of the proximal branch of the right m2.Another mechanical thrombectomy was performed with successful recanalization (tici 3) and no complications.The patient improved and their nihss score was 5 after 24 hours.On (b)(6) 2021 the patient showed clinical signs of aphasia and right hemiplegia.Ct imaging showed parenchymal hematoma type-2 (ph2) hemorrhagic transformation: left temporoinsular hemorrhagic lesions and the presence of hematic fluid-fluid levels associated with anticoagulation.Emergency reversal of anticoagulation was performed with protamine sulfate with aptt within normal limits.A repeat cranial ct was performed showing an increase of the mass effect and of the hematic content.The patient passed away on (b)(6) 2021.There were no device or procedural issues that resulted in the patient's death.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the patient experienced hemorrhagic transformation on (b)(6) 2021 with symptoms of visual disturbance, hemianopsia, aphasia, and global hemiparesis.In the face of progressive worsening, comfort measures were started before the patient passed away.The event was not the result of a device deficiency.The patient's mrs score was 1, and their nihss score was 3.The site assessed the event as caused by the disease under study and not related to the device or procedure.The sponsor assessed the event as possibly related to the procedure.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12259281
• MDR Text Key: 264501897
• Report Number: 2029214-2021-00962
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K182097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 80