MAUDE Adverse Event Report: MEDTRONIC MEXICO PHENOM; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-FG

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

Patient Problems Abscess (1690); Ischemia (1942); Pain (1994)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Okuyama t, kubota s, oishi h, ishige s, machida t.Anterior cerebral artery occlusion with middle cerebral artery stenosis successfully treated with endovascular thrombectomy and penumbra salvage in the middle cerebral artery territory: a case report.Interdisciplinary neurosurgery: advanced techniques and case management.January 2023.Doi:10.1016/j.Inat.2023.101753.B.3.Please note that this date is based off of the date of acceptance of the article as the event dates were not provided in the published literature 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

Okuyama t, kubota s, oishi h, ishige s, machida t.Anterior cerebral artery occlusion with middle cerebral artery stenosis successfully treated with endovascular thrombectomy and penumbra salvage in the middle cerebral artery territory: a case report.Interdisciplinary neurosurgery: advanced techniques and case management.January 2023.Doi:10.1016/j.Inat.2023.101753.Medtronic literature review found a report of patient complications in association with a phenom catheter.The purpose of this article was to report a case of anterior cerebral artery occlusion (acao) caused by cardiogenic cerebral embolism with diffuse stenosis of the horizontal portion of the middle cerebral artery (mca), in which thrombectomy was performed to acao and salvage of the mca territory penumbra was achieved.  a patient with atrial fibrillation presented to the emergency room with left hemiparesis and left hemispatial agnosia.They had stenosis of the right middle cerebral artery and occlusion of the right anterior cerebral artery.Ischemic symptoms were judged to be caused due to decreased blood flow in the collateral circulation because of occlusion of the right anterior cerebral artery, and thrombectomy was performed.Endovascular treatment was performed with a single plane angiography system (infx-8000, canon, tokyo, japan).A 4-fr 11 cm sheath (medikit japan) was inserted by right femoral artery puncture, and cerebral angiography was performed.Right common carotid angiography was performed, which confirmed raca occlusion without rmca occlusion consistent with mra findings.An 8-fr 25 cm sheath (medikit japan, tokyo, japan) was inserted through the right femoral artery, replacing a 4-fr 11 cm sheath.A 90 cm, 8-fr optimo (tokai medical products inc.) was placed in the right internal carotid artery.The pericallosal artery was selected beyond the occlusion site using a 200 cm 0.014-inch synchro2 (stryker) and 160 cm, 2.3¿2.7-fr phenom (medtronic).A catalyst6 (stryker) was induced in the a1 segment.A 4 mm × 28 mm trevonxt (stryker) was deployed from the distal segment of a2, and a stent-retrieving into an aspiration catheter with proximal balloon (asap) was conducted to retrieve the stent retriever (sr) only.The ac was occluded, so the ac was removed, and thrombolysis in cerebral infarction (tici) grade 3 recanalization was obtained; 99 and 396 min elapsed from puncture to reperfusion and from onset to reperfusion, respectively.Internal carotid angiography after revascularization show ed marked improvement in the perfusion from the raca to the rmca territory.On the next day, mri showed aspects-dwi of 11 points and no new ischemic area in the rmca territory, and the raca territory showed localized infarction in the area consistent with the pre- operative dwi high-signal area.Mra showed that the raca was recanalized and the rmcas was similar to the pre-operative findings.The left hemiplegia improved, with a national institutes of health stroke scale score of 9.No hemorrhagic infarction was occurred.Since the patient was experiencing cardiogenic cerebral embolism because of atrial fibrillation, the oral anticoagulant was changed from edoxaban 30 mg/day to apixaban 10 mg/day, and rehabilitation was started the day after the onset.The left upper limb paresis gradually improved, but they cannot leave the bed because of back pain.After a thorough examination, the diagnosis of iliopsoas abscess and lumbar epidural abscess was made, and the patient was transferred to the department of orthopedics on day 24.  the article does not state any technical issues during use of the phenom the following intra- or post-procedural outcomes were noted: -mri showed aspects-dwi of 11 points and no new ischemic area in the rmca territory, and the raca territory showed localized infarction in the area consistent with the pre-operative dwi high-signal area; mra showed that the raca was recanalized and the rmcas was similar to the pre-operative findings.-left upper limb paresis gradually improved, but they cannot leave the bed because of back pain.After a thorough examination, the diagnosis of iliopsoas abscess and lumbar epidural abscess was made, and the patient was transferred to the department of orthopedics on day 24.Additional information was received that device-related complications have not been recorded; there is no causal relationship to the device if the event means a long-prone myoencephaloma after the surgery.

Event Description

Additional information was received that noted that there is no causal relationship to the device if the event means a long-prone myo encephaloma after the surgery.

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: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17881161
• MDR Text Key: 325062223
• Report Number: 9612164-2023-04509
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female