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

Model Number	105-5095-000
Medical Device Problem Codes	Break (1069); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the tip of the catheter failed to detach as intended when ready to release.The physician was able to get the device to detach, but it ended up in a suboptimal position, which did not result in harm to the patient.
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 reported the patient¿s vessels had a dominant caliber left vertebral artery with a tortuous turn at the origin was the only vessel that was the only issue.However, the surgeon left the cook shuttle at the ostium of the vessel because of the tortuous turn.The patient was being treated for a large saccular aneurysm from the posterior aspect of the supraclinoid right internal carotid artery and a small pial avm with a nidus in the para-cerebral falcine left posterior cerebellar cortex supplied by pedicles from the hemispheric branches of left posterior inferior cerebellar artery.Onyx injection was halted several times when reflux was noted, allowing for the plug and push technique, injection was stopped when further reflux was noted.The timeline of onyx injections and pausing was as follows: 01:54:27 hand injection, 1:58:48: hand injection, 2:00:34: hand injection, 2:08:44: onyx liquid injected, 2:15:50: hand injection, 2:17:30: onyx liquid injected, 2:18:59: hand injection, 2:19:19: onyx liquid injected, 2:22:45: onyx delivery catheter removed on attempt to withdrawn, the apollo catheter appeared to be stuck recalcitrant line to the onyx plug.With fair amount of exertion, the catheter detached and was removed.Onyx cast was noted along the course of the mid to distal left posterior inferior cerebellar artery branch.A small speck of opacity was noted in the mid left superior cerebellar artery as well as the distal right superior cerebellar artery.Fracture of the microcatheter at the non-designated detachment point resulted in stretching of the microcatheter into the vertebrobasilar system, and small inadvertent/nontarget embolization into the left and right superior cerebellar arteries.The fractured microcatheter tip was then captured using stent retriever device with only a small distal portion, presumably the designated detachment zone, seen extending from the proximal left posterior inferior cerebellar artery into the proximal intradural left vertebral artery.This stretched microcatheter segment was jailed with a neuroform atlas stent.
Additional Manufacturer Narrative
H3: two apollo micro catheters were returned for analysis.Apollo 1 the biohazard pouch was labeled ¿clean, never went in patient¿.The apollo total length was measured to be 170.2cm and the usable length was measured to be 164.0cm, which is within specification.No damages or irregularities were found with the catheter hub or body.The ldpe coupling tube was still attached to the catheter.The detachable distal tip was already detached and not returned.The reason for the tip not returned was not given.No onyx residue was found within the hub or catheter.This apollo catheter is likely not the complaint unit as it does not appear to be used, confirming the note on the biohazard pouch.The reason for the catheter returned was not given.Apollo 2 the biohazard pouch was labeled ¿broken one¿.Onyx residue was found with the apollo catheter hub.The apollo catheter body was found bent at 49.9cm from the proximal end of the hub.The apollo catheter was found broken at 150.6cm from the proximal end.A second break was found at 3.2cm from the second break and a third break was found at 13.4cm from the second break.The separated ends were found stretched and the inner coil were exposed.The distal most segment, including the detachable tip, was not returned.The total length of the returned device is therefore 167.2cm and the total usable length is 161.0cm.The length of the missing catheter is therefore 1.5cm.Onyx residue was found within each of the catheter opening/breaks.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s reports of ¿cath separation due to onyx entrap.¿ and ¿catheter stretch during removal¿ was confirmed.The likely cause of the failure is due to retracting the device against the reported reflux.Other possible contributors are vasospasm, angioarchitecture, long catheter dwell time, user exceeded 20cm of traction, or tensile strength of tubing material is exceeded.The customer report of ¿tip non-detach¿ could not be confirmed through device analysis as the distal end of the catheter and detachable tip were not returned.Possible causes of failure are patient vessel tortuosity, high tensile value, reflux over ldpe coupling or biomechanical factors such as vasospasm.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
• MDR Report Key: 10893093
• Report Number: 2029214-2020-01174
• Device Sequence Number: 16895466
• Product Code: MFE
• UDI-Device Identifier: 00847536006010
• UDI-Public: 00847536006010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030004/S006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2021

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: 04/27/2023
• Device Model Number: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: B029884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/04/2021; 03/12/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 02/05/2021; 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 83