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

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2020
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 information regarding an axium coil that had poor positioning and detached prematurely during attempts to reposition.The patient was being treated for a ruptured saccular aneurysm of a posterior cerebral artery p1 segment with related subarachnoid h emorrhage.The maximum diameter was 4mm and the neck diameter was 2mm.Blood flow was normal and vessel tortuosity was moderate.It was reported that the microcatheter was delivered to the aneurysm location.The reported coil was being used to coil the frame but the framing with the coil was not stable so the physician attempted to reposition the coil.However, during the attempt, when half the coil was within the aneurysm and half the coil remained within the microcatheter, the coil did not move.It appeared the coil had detached from the pushwire.The pushwire was retrieved successfully and a 4mm snare was used to successfully retrieve the detached coil.The same microcatheter was then used with non-medtronic coils to successfully complete the procedure.All devices were prepared and continuous flush of the catheter was provided per the instructions for use (ifu).There was damage observed to the pushwire.No resistance was felt during delivery of the coil.No attempt had been made to detach the coil.The delivery pusher was not rotated within the patient's body.The repositioning of the coil was tried twice.There was no harm or injury to the patient related to the event.
Additional Manufacturer Narrative
H3: the axium prime pusher (model: apb-4-12-3d-ss lot: b056994) was returned for analysis.The actuator interface was found securely attached to the coupler tube with the twr crimps intact and the break indicator was found intact.There was no evidence of any detachment attempts at these locations.The coin was found still within the lumen stop with the shield coil present and slightly damaged.The implant coil was already detached and not returned for analysis.The outer jacket was removed to gain access to the coin.The coin was measured in 3 locations and found to be within specifications.Measured 0.072mm @ 0.063mm; measured 0.097mm @ 0.127mm; measured 0.096mm @ 0.275mm.The lumen stop was found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.0027¿ and found to be within specification.The retainer ring was found damaged.The retainer ring inner diameter (id) was measured to be 0.00490¿ which is no longer within specification.No other damages or abnormalities were observed.Based on the analysis performed, the customer report of ¿premature detachment¿ was confirmed as the device was returned with the implant coil already detached.It is likely the retainer ring became damaged, causing the detach element to slip out and detaching the implant coil.It is possible that excessive torsion was experienced by the pusher/implant lead to the retainer ring and shield coil damage found.Potential causes are patient vessel tortuosity, attempts to advance or retract device against resistance, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation and incompatible catheter.The physician reported patient vessel tortuosity as moderate, no resistance was felt during delivery, pusher was not rotated, repositioning was performed twice, and device was prepared as per ifu.As the implant coil and detach element were not returned, any contribution of the implant coil and detach element towards the premature detachment could not be determined.There was no non-conformance to specification identified that could potentially contribute towards the premature detachment.The customer¿s report of ¿poor lay up or framing¿ could not be confirmed.These complaints cannot typically be determined from device analysis and customer did not submit any images or videos for review.Possible causes of this failure are patient vessel tortuosity, catheter kick back, high blood flow and incorrect sizing of implant.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, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10755210
• Report Number: 2029214-2020-01069
• Device Sequence Number: 11715895
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 07/20/2023
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: B056994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1