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

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Codes	Break (1069); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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 failed to detach and became stretched.The patient was undergoing a coil embolization procedure to treat an unruptured saccular aneurysm.The aneurysm max diameter was 3.8mm and the neck diameter was 2.5mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported all devices were prepared according to the instructions for use (ifu).The microcatheter was in place for aneurysm filling.The axium coil (model: apb-1.5-2-3d-es) was chosen and, when deployed, could not be detached.After repeated attempts, the tail was stretched.Some of the coil remained in the aneurysm.The coil was removed, replaced, and the surgery was completed successfully.Additional information received indicated two detachment attempts were made with the instant detacher, and another two attempts with the manual method.There were no issues reported prior to non-detachment of the coil, no pushwire damage observed after removal, and it was stated there was no problem with the detachment device as it was used to detach other coils without issue.There was no injury to the patient.
Additional Manufacturer Narrative
H3: the axium prime coil (model: apb-1.5-2-3d-es lot: b065823) was returned for analysis.The instant detacher used during the event was not returned for analysis.The actuator interface was found loose on the coupler tube, indicative of a detachment attempt at this location.The axium prime pusher was found broken at the break indicator, indicative of a manual detachment attempt at this location.The axium prime pusher was found bent at ~99.0cm from the proximal end and found kinked at ~35.1cm from the distal end.The coin was found present and still against the lumen stop.Dried blood was found under the jacket and within the lumen stop.The shield coil was present and intact.The detach element was still attached to the pusher.The implant coil broken from the detach element and not returned for analysis.A detachment was then attempted by retracting the exposed release wire.The implant coil failed to detach as the release wire was found to be stuck within the pusher.The outer jacket was removed; and the dried blood was dissolved within an ultrasonic cleaner.The release wire came out of the lumen stop, detaching the detach element with no resistance and no issues encountered.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 to be slightly damaged, and the inner diameter was measured to be 0.0046¿ which is within specification.The detach element stick was found bent.No damages or irregularities were found with the coin.Based on the analysis performed, the customer report of ¿non-detachment¿ was confirmed as the device was returned with the detach element still attached to the pusher.The likely cause of the non-detachment is the dried blood found within the lumen stop, leading to the release wire not retracting the coin out of the lumen stop and subsequently causing the implant coil to not detach.After the dried blood was dissolved, retracting the release wire successfully detached the implant coil.The retainer ring was found damaged, indicative that excessive torsion was experienced by the pusher/implant.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 customer report of ¿coil stretch¿ could not be confirmed.The customer report of ¿coil separation/break¿ was confirmed.Possible causes of failure are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or user advances coil against resistance.The pusher was found bent/kinked indicative of advancing against resistance or damage during return shipping to medtronic for analysis.There was no non-conformance to specification identified that could potentially contribute towards the failures.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 BARE PL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11286380
• Report Number: 2029214-2021-00142
• Device Sequence Number: 3846352
• Product Code: KRD
• UDI-Device Identifier: 00847536031845
• UDI-Public: 00847536031845
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 08/06/2023
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: B065823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/27/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1