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

Model Number	APB-2-2-HX-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	01/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received report that when the axium coil (model apb-2-2-hx-es, lot: b197786) was delivered into the aneurysm sac, the coil could not be detached.The coil was removed and replaced.It was observed that the middle segment of the pusher was damaged.There had not been any friction or other difficulty during delivery of the coil but the physician did rotate the pusher.When the axium coil (model: apb-1.5-2-hx-es, lot: 222087536) was being delivered, the tip of the coil was stretched so the device was removed and replaced.It was noted there was no friction or other difficulty during delivery of the coil.The physician did not rotate the pusher during the deliver.Information in the report also indicated that both coils detached prematurely as well; the physician had not attempted to detach the 1.5-2 coil.It was noted that all devices were prepared according to the instructions for use (ifu).Continuous catheter flush was administered during the procedure.There was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a ruptured fusiform posterior communicating artery aneurysm.The aneurysm max diameter 6.1mm and the neck diameter 3.9mm.Blood flow was normal.Vessel tortuosity was minimal.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the issue with the apb-2-2-hx-es coil was that it could not be detached at all.2 attempts were made to detach the coil with the instant detacher and 2 attempts were made at manual detachment.The coil was not detached.
Additional Manufacturer Narrative
B5.Updated with additional information received.Pertains to prior report submitted with rr #: (b)(4) and device used in the same procedure as events reported for separate device in rr #: (b)(4).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.
Additional Manufacturer Narrative
H3: the axium prime coil was returned for analysis within a shipping box, within a plastic bio-pouch, and within an opened axium prime inner pouch.Visual inspection/damage location details: the axium prime pusher actuator interface (ai) was found intact.The axium prime pusher was found broken at ~3.3cm from the proximal end, at the positive load indicator (pli), retained by release wire.In addition, the pusher was found broken at ~7.5cm from the proximal end, at the hypotube break indicator (hbi), retained by the release wire.This indicates that there was an attempt to detach the implant using the manual method via hypotube.The release wire coin was found pulled back from the lumen stop and the implant coil detached.The detached implant coil was not returned.¿ testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿non-detachment¿ report could not be confirmed as the implant coil was found already detached.The instant detacher used in the event was not returned.In addition, the implant coil was not returned.Therefore, any contribution of the instant detacher or the implant coil towards the non-detachment could not be assessed.Regarding the customer¿s report of ¿pusher kink/damage¿ the issue was confirmed.However, the cause for the damage 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 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: 13342861
• Report Number: 2029214-2022-00097
• Device Sequence Number: 4064463
• Product Code: KRD
• UDI-Device Identifier: 00847536032163
• UDI-Public: 00847536032163
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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: 04/27/2024
• Device Model Number: APB-2-2-HX-ES
• Device Catalogue Number: APB-2-2-HX-ES
• Device Lot Number: B197786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2022
• Supplement Date Received by Manufacturer: 02/08/2022; 03/28/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/03/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG