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

Model Number	APB-1-2-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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 detached prematurely after failing to detach during detachment attempts.It was reported that during a prior revascularization procedure in the middle cerebral artery (mca), the patient's vessel was perforated and subarachnoid hemorrhage (sah) occurred.It was decided to use coil embolization for hemostasis.The axium prime 3d (model: apb-1-2-3d-es, lot: b041083) was used first.The coil was delivered through the microcatheter without resistance and detachment was attempted twice using a single instant detacher and once manually with the hypotube but detachment was not successful.It was noted that the area around the marker of the break indicator was forcibly bent during the detachment attempts.The pusher wire was bent and the release wire cut as well.At that point, an attempt was made to remove the entire system including the microcatheter to avoid detaching the coil but during the retrieval, the coil detached.However, the coil remained inside the microcatheter and all parts were successfully removed from the patient body together.It was noted that the delivery pusher was not rotated inside the patient's body.Continuous flush was administered during the procedure without interruption.An axium prime 3d 1-4 was then used instead and was successfully implanted and detached to complete the procedure.There was no harm or injury to the patient associated with this event.
Additional Manufacturer Narrative
H3.Product analysis findings: the axium prime pushwire was returned for evaluation within the inner pouch; inside of a biohazard bag and a shipping box.There was no catheter, implant coil, detached element or instant detacher returned with the pushwire.The implant coil appeared to be detached from the pushwire.The shield coil was found intact but stretched.The coin was not present against the lumen stop as it was pulling back.The pushwire was found to be broken at the break indicator; with the release wire pulling back; indicative that manual detachment was attempted at this location.The break indicator, positive load indicator, ai and coupler tubing were found to be missing from the proximal end of the pushwire.Bends were found along the length of the pushwire.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.082mm @ 0.127mm; measured 0.096mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00269¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00460¿and found to be within specification.All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the axium prime coil was confirmed to have "premature detachment" and "pushwire kink/broke" issues as the pushwire was returned with the implant coil already detached.Bends were found on the pushwire.It is likely that these damages occurred when the customer attempted to advance the axium prime coil through the catheter against the reported resistance.However, the cause for resistance could not be determined.Possible causes of resistance include the use of damaged catheter, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was found to be broken at the manual detachment location and retained by the release wire; with the coin pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.There was no non-conformance to specification identified that led to the non-detachment issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the catheter, instant detacher, implant coil and the detached element, break indicator, positive load indicator, ai and coupler tubing were not returned; any contribution of the catheter, instant detacher, implant coil and detached element, break indicator, positive load indicator, ai and coupler tubing to the reported issues could not be determined.H6.Coding updated based on analysis results.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
• MDR Report Key: 11654171
• Report Number: 2029214-2021-00416
• Device Sequence Number: 17024226
• Product Code: KRD
• UDI-Device Identifier: 00847536021112
• UDI-Public: 00847536021112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/30/2021

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: 06/16/2023
• Device Model Number: APB-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: B041083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1