MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1-2-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: an echelon-10 micro catheter and axium prime coil were returned for analysis.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium prime coil ifu (instructions for use): ¿axium detachable coils should be delivered through a micro catheter with a minimum inside diameter of 0.0165¿-0.0170¿ with two marker bands.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium prime coils.The total length of the echelon-10 micro catheter body was measured to be ~155.5cm (reference: 155.0cm).The useable length of the micro catheter was measured to be ~147.7cm which is within specification (specification: 147.0cm ± 1.5cm).Upon visual inspection, no issues or irregularities were found with the echelon-10 micro catheter hub or distal tip.No bends or kinks were found with the echelon-10 micro catheter body.The echelon-10 micro catheter was used for resistance testing with an in-house mandrel and was able to pass through the echelon-10 micro catheter hub and subsequently through the inner lumen and tip without issue.The axium prime coil was returned within introducer sheath.The introducer sheath appeared to have been damaged (skived) at distal tip.No bends or kinks were found with the axium prime coil pushwire.The implant coil was found to be missing and not returned with polypropylene filament intact.All other subassemblies appeared to be normal and no other anomalies were observed.The implant coil could not be used for resistance testing with the returned echelon -10 micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, and lack of continuous flush during delivery.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ could not be confirmed as no resistance or difficulties were encountered when passing an in-house mandrel through the echelon-10 micro catheter.Possible factors that can cause resistance can be caused by insufficient catheter flush or insufficient coil preparation.This regulatory report is being submitted as part of a retrospective review.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
Medtronic received a report that the axium coil experienced resistance in the distal part of the echelon 10 microcatheter.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the right posterior communicating artery.The max diameter was 4 mm.The neck diameter was 3 mm.The patient¿s blood flow and vessel tortuosity were normal.The access vessel was the femoral artery, and it was 7 mm in diameter.It was reported that the spring coil could not be pushed out of the catheter.The patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Additional information received reported that the axium coil push out of the introducer sheath smoothly.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 17430056
• Report Number: 2029214-2023-01246
• Device Sequence Number: 20630538
• Product Code: KRD
• UDI-Device Identifier: 00847536032095
• UDI-Public: 00847536032095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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
• Report Date (Section B): 07/31/2023

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: 07/22/2023
• Device Model Number: APB-1-2-HX-ES
• Device Catalogue Number: APB-1-2-HX-ES
• Device Lot Number: B057851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female