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

Model Number	PV-16-40-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id id-1 (lot: unknown); product type: ; implant date n/a; explant date n/a medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the coil detacher failed to function during the procedure and the procedure was completed using a new product.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was unknown if patient symptoms or complications were associated with this event.
Event or Problem Description
Additional information received that the patient recovering from the procedure fine.No patient symptoms or further complications were reported as a result of this event.There are no procedural / post-procedural imaging (ct,angio, etc.) available.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: as found condition: the concerto device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened concerto outer carton and outside its returned introducer sheath.Visual inspection/damage location details: the concerto pusher was found wrapped up and tied into a knot by the customer prior to return shipping.The actuator interface was found to be securely attached to the coupler tube.There were no evidence of detachment attempts using an instant detacher at this location.The break indicator was found kinked but otherwise unbroken.There were no evidence of manual detachment attempts at this location.The coin was found undamaged.The distal pusher and implant coil were found broken from the remaining pusher and not returned for analysis.Testing/analysis: n/a conclusion: based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the implant and distal pusher segment were not returned for analysis.The damages found on the pusher from the knotting possibly contributed towards the non-detachment.However, it is unclear what damages were on the pusher during the procedure.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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19202714
• Report Number: 2029214-2024-00785
• Device Sequence Number: 18114803
• Product Code: KRD
• UDI-Device Identifier: 00847536045040
• UDI-Public: 00847536045040
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 08/19/2025
• Device Model Number: PV-16-40-HELIX
• Device Catalogue Number: PV-16-40-HELIX
• Device Lot Number: B461694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided; 05/25/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/17/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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 Sex: Unknown