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

Model Number	PV-20-50-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id pv-18-40-helix ((b)(6)); implant date n/a; explant date n/a product id pv-18-40-helix ((b)(6)); 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 information regarding three concerto coils that had resistance in the non-medtronic catheter, one of which detached prematurely in the microcatheter.The patient was undergoing a coil embolization procedure to treat an unruptured aneurysm located in the superior mesenteric artery (sma).Patient vessel tortuosity was moderate.It was reported that the devices were prepared according to the instructions for use (ifu).The coils pushed out of the introducer s heath smoothly.The physician experienced resistance and difficulty advancing the coils through the microcatheter.Despite attempts with and without a y-connector, the coils did not advance past the proximal part of the catheter.One of the coils detached within the microcatheter, but its tail remained outside, allowing it to be pulled out.No surgical or medicinal intervention was required.It was noted the physician did not reposition or attempt to detach the coil and the pushwire was not damaged.It was not specified which of the three coils detached prematurely.There was no harm or injury to the patient associated with this event.The coils were replaced with another manufacturer's product to complete the procedure successfully.Ancillary device: progreat 2.4 microcatheter, cordis 5f femoral sheath, cobra 5f guide catheter.
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.
Event or Problem Description
Additional information received that it was believed one of the the 18mm coils prematurely detached in the catheter, but it is not certain.The microcatheter was flushed before each coil, but there was no continuous irrigation.There was no kink/damage to the catheter observed after removal.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21256893
• Report Number: 2029214-2025-00236
• Device Sequence Number: 8093192
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: 00847536045064
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Model Number: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: B718981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 75 KG