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 Problem Unspecified Infection (1930)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: moosa, s.S., hasan, h., leyon, j.J., redha, n.A., <(>&<)> humaidan, h.Things are not what they seem neurologically and radiologically: an apt descriptor for spinal dural arteriovenous fistula (sdavf).Radiology case reports 18(11):4123-4129 2023.Doi:10.1016/j.Radcr.2023.08.082 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 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

Moosa ss, hasan h, leyon jj, redha na, humaidan h.Things are not what they seem neurologically and radiologically: an apt descriptor for spinal dural arteriovenous fistula (sdavf).Radiology case reports.2023;18(11):4123-4129.Doi:10.1016/j.Radcr.2023.08.082 medtronic literature review found a report of patient complications in association with an apollo catheter.The purpose of this article was to present a case of spinal dural arteriovenous fistulas (sdavf) that was missed by the treating orthopedic surgeon and underwent spinal decompression with subsequent persistence of myelopathic symptoms.The patient was successful embolized with improved clinical outcomes for the patient using precipitating hydrophobic injectable liquid (phil) embolic agent delivered through an apollo catheter.The article does not state any technical issues during use of the apollo.The following intra- or post-procedural outcomes were noted:  - postembolization, the patient stayed in the hospital and underwent physical rehabilitation.The plan was to transfer the patient to a rehabilitation center.However, they didn¿t fulfill the requirements for transfer due to hospital-acquired infections and was discharged home where they had ongoing physiotherapy care.

• 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: 18717921
• MDR Text Key: 335527296
• Report Number: 2029214-2024-00297
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: BA
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• Date Manufacturer Received: 02/08/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR