MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-APOLLO

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

Patient Problems Ischemia (1942); Muscle Weakness (1967); Paraplegia (2448); Respiratory Failure (2484)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx (); product type: ; implant date ; explant date product id unk-nv-fg (); product type: ; implant date ; explant date g2: citation: authors: moazeni, y., cantrell, d.R., clark, j.R., abdalla, r.N., batra, a., hurley, m.C., ansari, s.A., russell, e.J., shaibani, a.Case report: anterior spinal cord ischemia following embolization of cerebellar arteriovenous malformation: an illustrative case and review of spinal cord vascular anatomy.Frontiers in neurology 12:725065 2021.Doi:10.3389/fneur.2021.725065.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 # 2029214-2023-01450 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.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

Moazeni y, cantrell dr, clark jr, et al.Case report: anterior spinal cord ischemia following embolization of cerebellar arteriovenous malformation: an illustrative case and review of spinal cord vascular anatomy.Frontiers in neurology.2021;12:725065.Doi:10.338 9/fneur.2021.725065.Medtronic literature review found a report of patient complications in association with onyx liquid embolic, an apollo microcatheter, and a phenom plus catheter.The purpose of this article was to report the occurrence of anterior spinal cord ischemia (sci) following successful embolization of a cerebellar arteriovenous malformation (avm), marked by upper extremity weakness, lower extremity paraplegia, loss of bladder and bowel control, and hypercapnic respiratory failure requiring mechanical ventilation.The article does not state any technical issues during use of the onyx, apollo, or phenom.The following intra- or post-procedural outcomes were noted:  - neurosurgical consultation recommended surgical resection of the avm, and pre-surgical embolization was requested to minimize the risk of intraoperative bleeding.Embolization had resulted in an approximately 50% reduction in the size of the avm nidus, and a decision was made to terminate the exam.The patient awoke from the procedure, but experienced progressive weakness over the next 24 hours.On evaluation 1 day post-procedure, she had a strength of 1/5 and 2/5 in proximal and distal muscle groups of both upper extremities, respectively, with a strength of 2/5 in both lower extremities.Pinprick and temperature sensation were decreased at the approximate level of c2¿c4 throughout the lateral torso and both upper extremities, while vibration and proprioception remained intact in all extremities.These findings reinforced the diagnosis of acute sci.A second brain mri at this time showed evidence of t2/flair hyperintense signal and increased diffusion restriction in the right cerebellar hemisphere at the site of onyx embolization.As a result of the sci, she developed hypercapnic respiratory failure requiring urgent endotracheal intubation and mechanical ventilation.She eventually required tracheostomy placement for anticipated prolonged ventilator weaning along with percutaneous gastrostomy placement.She was successfully weaned off the ventilator and resumed oral intake by 3 weeks, and underwent acute inpatient rehabilitation for a total 4 months, and is now residing at home with significant assistance.It was believed by the authors that the use of a five french sheath in the left vertebral artery (va), which is comparable in diameter to a six or seven french guide catheter, and even in the absence of catheter wedging and flow limitation, there was enough reduction in perfusion pressure to the anterior spinal artery (asa) through the artery of cervical enlargement to cause sci.

Event Description

Additional information received reported that the injury was not directly the result of any of the medtronic or other devices used.

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: APOLLO
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• 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: 17597044
• MDR Text Key: 321666007
• Report Number: 2029214-2023-01451
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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-APOLLO
• Device Catalogue Number: UNK-NV-APOLLO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/19/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female