MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3.5-6-3D-ES
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium prime coil experienced resistance in the echelon 10 microcatheter, was stretched, and broke/separated/prematurely detached.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the left anterior communicating artery aneurysm.The max diameter was 4mm, and the neck diameter was 3mm.The patient's blood flow and vessel tortuosity were normal.It was reported that after the coil was stuck in the catheter, they took the push rod and coil out of the body and found that the coil body was stretched.No additional medical or surgical intervention was needed.The pushwire was not bent or broken.The physician did not reposition the coil, no detachment attempts had been made, and the delivery pusher was not rotated during the procedure.A continuous flush had been administered. the coil was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
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 reported the coil body was damaged and stretched.The resistance was in the distal section of the catheter.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): ¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) and 0.0265¿ mandrel ¿drawing(s) referenced: n/a ¿as found condition: the axium prime coil was returned for analysis within a shipping box; within a plastic bio-pouch; within an opened axium prime inner pouch; and a dispenser coil.The echelon-10 micro catheter used in the event was not returned.Therefore, device analysis could not be performed and conformance to specifications could not be determined.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿ therefore, the echelon-10 micro catheter was found compatible for use with the axium prime coil.¿visual inspection/damage location details: the axium prime coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.There is no evidence of any detachment attempts by mechanical or manual methods.No bent or kink were found with axium prime pushwire.The axium prime implant coil was still attached to the pushwire.The axium prime implant coil was found to be damaged and stretched within introducer sheath.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.¿testing/analysis: the axium prime coil could not be pushed out from the introducer sheath as it was appeared to be stuck.Due to its damaged condition, the axium prime coil could not be used for resistance testing with an in-house catheter.¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter ¿and ¿coil stretch¿ were confirmed as the axium prime implant coil was found damaged and stretched within the introducer sheath.However, based on the device analysis and the reported information, the customer¿s report of ¿premature detachment¿ could not be confirmed as the axium implant coil was still attached to the pushwire.However, the root cause could not be determined.Advancing the axium prime coil against resistance would result in damage to the implant coil.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.The echelon-10 micro catheter used in the event was not returned; therefore, any contributing factors (other than inner diameter specification) could not be assessed.The echelon-10 micro catheter was found to be compatible, the axium prime coil was prepared prior to use (which includes coil hydration), and the vessel tortuosity was ¿normal¿.However, information regarding use of a continuous flush was not reported.Therefore, any contributing factors could not be assessed.(nikkhs2 2022-07-13).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: AXIUM PRIME BRPL 3D
• 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: 14087173
• Report Number: 2029214-2022-00616
• Device Sequence Number: 11296260
• Product Code: KRD
• UDI-Device Identifier: 00847536021259
• UDI-Public: 00847536021259
• 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,Followup,Followup
• Report Date (Section B): 07/28/2022

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: 11/03/2023
• Device Model Number: APB-3.5-6-3D-ES
• Device Catalogue Number: APB-3.5-6-3D-ES
• Device Lot Number: B111715
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 04/23/2022; 07/14/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/21/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: 53 YR
• Patient Sex: Female