MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	PV-18-40-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that the concerto coil could not be detached with the instant detacher or by manually.The coil was retrieved and another coil was used to continue the procedure.It was noted the device was prepared and inspected per the instructions for use (ifu).There was no harm or injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 that 28 detachment attempts were made with the instant detacher, and 7-8 were made with the manual method.Prior to the non-detachment there were no issues encountered, and no damage was observed to the pushwire after removal.
Additional Manufacturer Narrative
Product analysis: as found condition- two coils were returned for analysis within in a shipping box, within a sealed plastic biohazard pouch; within an opened concerto outer carton; within an opened concerto inner pouch and within a plastic pouch.Visual inspection/damage location details: the pusher was found broken at the break indicator, indicative of a manual detachment attempt at this location.The proximal segment (actuator interface, positive load indicator, and portion of the break indicator and coupler tube) was not returned for analysis.Therefore, evidence of detachment attempts using an instant detacher could not be assessed.The release wire was found extending out of the distal segment.The coin was found still against the lumen stop.The shield coil was found intact and unstretched.The implant coil was found still attached to the pusher.The implant coil was found to be undamaged.It is likely the implant coil was still attached to the pusher.Testing/analysis ¿ the exposed release wire was retracted, and the coin retracted out of the lumen stop with no issues and no resistance encountered.The implant coil became detached with no other issues found.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed for the first coil.It is likely the cause of the non-detachment is the release wire became separated from the actuator interface causing the release wire to not retract during the detachment attempts.When the release wire was retracted during in-house analysis, the coin exited the lumen stop and the implant coil detached as expected by the detachment elements.The cause of the detachment from the actuator interface could not be determined.As the proximal segment of the pusher was not returned, the crimps could not be confirmed.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment could not be determined.It is possible the issue could be related to a manufacturing issue, therefore, a device history review will be conducted.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.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: CONCERTO PGLA 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: 12493070
• Report Number: 2029214-2021-01175
• Device Sequence Number: 3349955
• Product Code: KRD
• UDI-Device Identifier: 00847536033672
• UDI-Public: 00847536033672
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/14/2021

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: 05/12/2024
• Device Model Number: PV-18-40-HELIX
• Device Catalogue Number: PV-18-40-HELIX
• Device Lot Number: B205285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 12/08/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/14/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female