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

Model Number	105-5096-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was being treated with onyx les for a dural arteriovenous fistula (davf) (off label).The doc was going up the left external carotid and into the middle meningeal artery (mma) then noticed the catheter had detached (prior to the detachable tip).No onyx was pushed yet.This was at the beginning of the case.There was catheter separation/break during use.There was no friction or difficulty during injection.There was no force applied during delivery or removal.The catheter tip was not entrapped or stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.There was no surgical or medicinal intervention required.The broken location was distal.The broken segments (4-5cm) remain in the patient's left mma.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing surgery for treatment of dural av fistula with onyx (off-label.) it was noted the patient's vessel tortuosity was moderate.The access vessel was the left external carotid and mma.Ancillary devices include a benchmark 6fr 95cm (lot # f00007811) guide catheter, vecta 46 (intermediate catheter) (lot# 21572-01) guide catheter, asahi chikai 10 (wain-cki-10-200) (lot # 210315a23a) guidewire, onyx18 liquid embolic.
Additional 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.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.
Additional Manufacturer Narrative
Product analysis #295430642:¿ equipment used: vis (m-81805), digital snap gauge (m-79527) ¿ as found condition: the apollo micro catheter was returned for analysis within a shipping box, an opened apollo outer carton (b523065), and an opened apollo inner pouch (b523065).¿ damage location details: a guidewire was found extending out from within the apollo catheter hub for ~20.0cm.No damages were found with the apollo catheter hub.No bends or kinks were found with the apollo catheter body.The apollo distal tip was found detached from the catheter.The guidewire was found extending out from within the apollo catheter distal end for ~11.0cm.The guidewire distal coiled region was found bent.The guidewire distal tip was found bent.The characteristics of the bent guidewire distal tip are consistent with tip shaping.¿ testing/analysis: the guidewire was removed from within the apollo micro catheter without issue.The guidewire distal coiled outer diameter (od) was measured to be 0.010¿.The apollo catheter ldpe tubing overlap was measured to be 1.7mm, which is within specification (specification: 1.0-2.5mm) ¿ conclusion: based on the device analysis and reported information, the customer¿s report was confirmed.The returned apollo catheter distal tip was found detached from the catheter.Tip premature detachment (during navigation) can occur if the catheter is navigating or repositioning while in a wedged position or with vessels in vasospasm.In addition, the use of an incompatible guidewire, guidewire damage, advancing the guidewire against resistance, detachment joint ldpe/tip overlap length too short, or too much calcification (tip gets caught and dislodges).The ldpe tubing overlap was measured to be within specification.In addition, it was reported there was no vasospasm, the catheter tip was not entrapped or stuck, and the guidewire used in the event is compatible for use with the apollo micro catheter.However, vessel calcification could not be ruled out as a potential cause.Information regarding if there was any guidewire resistance was not reported.It is possible the damage found with the guidewire contributed to the reported event.However, the cause could not be determined.(rosaj10 2023-11-09) 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
• Common Device Name: 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: 17890282
• Report Number: 2029214-2023-01975
• Device Sequence Number: 20567506
• Product Code: MFE
• UDI-Device Identifier: 00847536006041
• UDI-Public: 00847536006041
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2026
• Device Model Number: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: B523065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male