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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
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 axium prime coil prematurely detached.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the right anterior communicating artery.The max diameter was 5mm, and the neck diameter was 3mm.The patient's blood flow and vessel tortuosity was normal.It was reported that the coil automatically detached, and was removed with a thrombectomy stent.No additional medical/surgical intervention was required.The pushwire was not bent or broken, there was no friction or difficulty during delivery, and the physician did not reposition the coil.No detachment attempts had been made.The physician did not rotate the delivery pusher during the procedure.A continuous flush had been administered. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a solitaire ab.
Additional Manufacturer Narrative
H3: the axium prime pusher was returned within its introducer sheath.The axium prime pusher was found to be inverted within the introducer sheath with the wavelock at the distal 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 the axium prime pusher.The implant coil was already detached and not returned for analysis.The coin was present and against the lumen stop.The shield coil was found intact.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.In addition, the retainer ring inner diameter (id) was measured to be within specification.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be damaged (ovalized).The axium prime coil could not be used for resistance testing as it was already detached.Based on the device analysis and reported information, the customer¿s report of ¿premature detachment¿ was confirmed as the implant coil was returned already detached.The likely the cause is due to the damage to the retainer ring, causing detach element to slip out, detaching the implant coil.Possible causes for retainer ring damage are: lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one to one motion with the implant pusher during repositioning, pushwire rotation, user advances/retract the coil against resistance, or incompatible catheter.Customer reported no detachment attempts had been made, continuous flush was maintained, device was hydrated per ifu, no coil repositioning, pushwire not rotated, and patient vessel tortuosity as normal.There was no malfunction of the pusher/implant coil or non-conformance to specification that may have contributed to the pre-mature detachment.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 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: 14408277
• Report Number: 2029214-2022-00829
• Device Sequence Number: 2619810
• Product Code: KRD
• UDI-Device Identifier: 00847536032125
• UDI-Public: 00847536032125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/02/2022

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: 02/05/2024
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: B156870
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: 63 YR
• Patient Sex: Female