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

Model Number	PV-6-20-3D
Medical Device Problem Codes	Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Ischemia Stroke (4418); Foreign Body Embolism (4439)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
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
Medtronic received information that a concerto coil migrated and an echelon had difficult navigation.1st did left superior vena cav a (svc) ¿ very tortuous used echelon couldn¿t get 4fr guide cath.So couldn¿t put a plug, so coiled with a 3d 6x20.Thinks it may have been oversized because it didn¿t pack well.Proximal tortuosity.Grabbed micro and was going to put in a 2nd coil but when micro touched it the coil moved distally, to a segment that was in a larger diameter segment of the vessel.The healthcare provider (hcp) was considering snaring it and got a 2nd opinion.The coil appeared to be in a stable position, so they didn¿t snare it.Then embolized very proximally with a 5x15 3d.It moved to the right side.  did the mvps and stent and finished the case and it remained stable.Someone came in and switched his g tube to a j tube and they did 3 fluoros and the coil hadn¿t moved.The g tube was very close to the coil.Next day the coil wasn¿t where they last saw it.After looking for it, they found it had embolized to left internal carotid.Took him to neurosurgery.Cerebral angio.Craniotomy.Dissected to left middle cerebral artery.Duel anti platelet therapy.Had a stroke on saturday and a few strokes since.He has a ct scan every day.There is still flow through the coil.Currently on heparin <(>&<)> aspirin <(>&<)> plavix.The patient was undergoing venovenous collateral bilateral bi directional glenn 1 left 2 right off superior vena cava.
Event or Problem Description
Additional information was received that the patient is doing well.Actions taken included monitoring the patient.The device was prepared as indicated in the ifu.
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.

• 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: 19554920
• Report Number: 2029214-2024-01092
• Device Sequence Number: 12463932
• Product Code: KRD
• UDI-Device Identifier: 00847536033788
• UDI-Public: 00847536033788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2025
• Device Model Number: PV-6-20-3D
• Device Catalogue Number: PV-6-20-3D
• Device Lot Number: B419442
• 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: 06/01/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 07/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 MO
• Patient Sex: Unknown