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

Model Number	PC-2-6-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
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 a report that the axium detachable spring coil could not be detached during the surgery.The patient was being treated for an unruptured saccular ophthalmic artery segment aneurysm.The max diameter was 7 mm and the neck diameter was 2.8 mm.The patient¿s blood flow and vessel tortuosity was unknown.It was reported that the physician attempted to detach the coil with the instant detacher 5 times.The physician also tried 4 times with another instant detacher.There were also 5 attempts of a manual detachment via hypotube.There were no issues with the instant detacher.The devices were prepared according to the instructions for use (ifu).There were no patient symptoms or complications.There were no patient symptoms or complications associated with this event ancillary devices included codis 8f sheath, navien 5f guide catheter, echelon 10 microcatheter, and a boston scientific guidewire.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received reported there were no issues encountered during the procedure prior to the coil non-detachment.There was no damage observed to the pushwire after removal from the patient.
Additional Manufacturer Narrative
H3.Product analysis: the axium coil was returned for analysis within a shipping box, within bubble packaging wrap, within a dispenser coil and within an introducer sheath.The introducer sheath was found stuck within the dispenser coil.The instant detacher used in the event was not returned for analysis.The actuator interface was found to be securely attached to the coupler tube.There was no evidence of detachment attempts using an instant detacher at this location.The break indicator was found intact.There were no evidence of manual detachment attempts at this location.The axium pusher was found to be kinked at ~7.1cm and 5.6cm from the distal end.The coin was found present and still against the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found to be damaged.A detachment was attempted using an in-house instant detacher, which successfully detached the implant coil with no issues on the first attempt.No other damages or anomalies were found with the returned device.Based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the device was returned with the implant coil still attached, however, the cause could not be determined, and the failure could not be replicated as the device detached successfully using an in-house instant detacher.The customer reported attempting to detach using an instant detacher 5 times, 4 times with a second instant detacher, however, no breaks were found with the actuator interface.The implant coil was found damaged, and pusher was found kinked.Possible causes include, but not limited to, lack of hydration before procedure, continuous flush not performed during procedure (or insufficient continuous flush), tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances/retracts the coil against resistance or incompatible catheter.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment and conformance to specification could not be assessed.There is no indication that the event is related to a potential manufacturing issue, therefore a device history record review was not required.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.

• Brand Name: AXIUM PGLA 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: 12259924
• Report Number: 2029214-2021-00965
• Device Sequence Number: 16865288
• Product Code: KRD
• UDI-Device Identifier: 00847536014145
• UDI-Public: 00847536014145
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: 08/27/2023
• Device Model Number: PC-2-6-3D
• Device Catalogue Number: PC-2-6-3D
• Device Lot Number: B076649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 10/14/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/31/2021; 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR