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

Model Number	PV-3-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that three different sized concerto coils could not be introduced through a 2.4f microcatheter even though there was a y-adapter and flushing was made properly.They needed to take a new coil for each size to complete the intervention.It was reported there was coil resistance/stuck in the catheter.It was reported the concerto coils did not go through the microcatheter.Patient was un-injured.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.There were no abnormalities reported in relation to anatomy.2024-jul-22 e1 (for, rep, hcp): no new event information received.2024-jul-23 email x2 (for, rep, hcp): additional information received reported that a new coil had to be opened at a time.A serious consequence did not actually arise for the patient, user or third party.A possible serious consequence noted was a delay of the procedure.2024-aug-12 e2, e3, e4 (for, rep, hcp): no new event information.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): a concerto coil was returned for analysis within a shipping box; within a sealed plastic bag and within an opened concerto implant coil inner pouch.The unknown micro catheter used in the event was not returned.The implant coils were returned within their introducer sheaths.Visual inspection/damage location details: the concerto coil pushwire was found to be kinked at ~ 5.5cm and pushwire broken but retained by release wire at ~149.2cm from proximal end.The implant coil was found to be stretched and damaged within introducer sheath.The axium implant coil was unable to be pushed out of introducer sheath for further analysis as it was found to be stuck.All other subassemblies appeared to be normal, and no other anomalies were observed.Testing/analysis (including sem reports): the concerto coils could not be used for resistance testing with an in-house micro catheter due to their damaged condition.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: 20422339
• Report Number: 2029214-2024-01840
• Device Sequence Number: 18044365
• Product Code: KRD
• UDI-Device Identifier: 00847536045125
• UDI-Public: 00847536045125
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 10/10/2024

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 Model Number: PV-3-8-3D
• Device Catalogue Number: PV-3-8-3D
• Device Lot Number: B714287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/10/2024
• Date Device Manufactured: 04/04/2024
• 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
• Patient Sex: Female