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

Model Number	APB-2-3-HX-ES
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
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 during deployment, the microcatheter kicked back.As a result the physician tried to reposition but the coils became stretched and detached suddenly.The coil was removed using 2 stent retrievers.The patient was undergoing surgery for treatment of an unruptured, saccular right mca aneurysm with a max diameter of 4.5mm and a neck diameter of 5mm.It was noted that the blood flow and vessel tortuosity were normal.The physician did not attempt to detach the coil, nor did they rotate the delivery pusher during procedure.A continuous flush was used.There were no related patient symptoms.Ancillary devices include a neuronmax sheath, synchro guidewire.
Additional Manufacturer Narrative
D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated as received, axium prime implant coil returned detached from the pushwire.The implant coil found damage and stretch with detach element was still attached to the polypropylene filament.No other anomalies were observed.Based on the reported information and returned device analysis, we were unable to determine the cause of "premature detachment" of the implant.Possible causes of premature detachment are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, user advances coil against resistance, or damaged pushwire.Pushwire was not returned, therefore, any contribution of the pushwire could not be determined.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
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8754802
• Report Number: 2029214-2019-00667
• Device Sequence Number: 2280655
• Product Code: KRD
• UDI-Device Identifier: 00847536020993
• UDI-Public: 00847536020993
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 03/28/2022
• Device Model Number: APB-2-3-HX-ES
• Device Catalogue Number: APB-2-3-HX-ES
• Device Lot Number: A806958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR