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

Model Number	105-5096-000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the apollo catheter tip was detached prematurely.The patient was undergoing surgery for treatment of an arteriovenous malformation (avm).The accessed vessel was the femoral artery with a diameter of 8.2 mm.It was noted the patient's vessel tortuosity was normal.It was reported that before the apollo catheter was in place, the tip was detached prematurely.There was no friction or difficulty during injection.It was reported the tip was detached prematurely and remained in the body.There was no force applied during removal.The catheter tip was not entrapped/stuck.There was no vasospasm.There was no surgical or medicinal intervention required.This did not occur during onyx injection.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a neuronmax sheath, synchro guidewire, onyx 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.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.
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.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 or Problem Description
Additional information received that the patient recovered well after the operation.There are no procedural / post-procedural imaging (ct ,angio, etc.) available.The actions/interventions taken to resolve the premature tip detachment included pushing the tip end that has been detached prematurely to the part to be glued.The procedure was completed by pushing the tip end that has been detached prematurely to the part to be glued; replaced with new apollo glue.The tip detachment occurred during navigation through the guide catheter.There was no resistance when the apollo was being advanced.There are no¿future plans to retrieve the catheter tip.The anatomical location of the apollo tip is in the m2.There was no note of vessel calcification.There was no kink or damage noticed on any of the devices.
Additional Manufacturer Narrative
H3: product analysis #(b)(6): equipment used: vis (m-78210) drawing(s) referenced: dwgs105-5096-000 rev.Ae as found condition: the apollo micro catheter was returned for analysis within a shipping box and within a plastic bio-pouch.Damage location details: no damages were found with the apollo catheter hub.No bends or kinks were found with the apollo catheter body.The apollo catheter distal tip was found detached from the catheter.The detached tip was not returned.Testing/analysis: the apollo catheter ldpe overlap was measured to be 1.35mm which is within specification (specification: 1.0-2.5mm).Conclusion: based on the device analysis and reported information, the customer¿s ¿tip premature detachment¿ report was confirmed.Tip premature detachment (during navigation or repositioning) can be caused by vessel tortuosity, use of an incompatible guidewire, or if the detach joint ldpe overlap length is too short.Tip premature detachment can also occur due to too much vessel calcification (tip gets caught and dislodges) or repositioning of the micro catheter while it is in a wedged position or with vessels that are in vasospasm.The patient¿s vessel tortuosity was ¿normal¿, ruling out ¿patient vessel tortuosity¿ was a potential cause.The (stryker) synchro guidewire used in the event was not returned.In addition, the guidewire model was not reported.Therefore, any contributing factors from the guidewire could not be assessed.The ldpe overlap was measured to be within specification, ruling out ¿ldpe overlap length is too short¿ as a potential cause.There was no indication of vessel calcification, ruling out ¿vessel calcification¿ as a potential cause.It is possible that the apollo catheter tip detached during repositioning.However, the cause for the tip premature detachment could not be determined.(rosaj10 2023-08-04) 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: 17117156
• Report Number: 2029214-2023-00916
• Device Sequence Number: 12562880
• Product Code: MFE
• UDI-Device Identifier: 00847536006041
• UDI-Public: 00847536006041
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2025
• Device Model Number: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: B428196
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 08/04/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/15/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Unknown