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

Model Number	PV-3-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that three concerto coils would not advance in microcatheter very far before getting stuck.Only would advance just past the hub.It was reported there was coil resistance/stuck in the proximal section of the catheter.The coil (lot # 227937283) did push smoothly out from the introducer sheath.No patient symptoms or further complications were reported as a result of this event.Additional information was received reporting the cause of the resistance was not determined.
Additional Manufacturer Narrative
H3:equipment used: vis (m-85519), 203cm ruler (m-83360) document used: n/a as found condition (condition of returned device): 3 concerto implant coils were returned within a shipping box; within an opened plastic bag; within their opened concerto coil outer cartons; within their opened concerto coil inner pouches and within dispenser tracks.The unknown micro catheter used in the event was not returned.Visual inspection/damage location details: (pli-10) the concerto implant coil was returned out of introducer sheath.The concerto coil pushwire was found to be kinked at ~ 166.0cm from proximal end.The implant coil was found to be stretched and damaged.The shield coil was found to be intact.All other subassemblies appeared to be normal, and no other anomalies were observed.(pli-20) the concerto implant coil was returned within introducer sheath.No bends or kinks were found with the concerto coil pushwire.The implant coil was found to be stretched and damaged.The implant coil was unable to be pushed out from 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.(pli-30) the concerto implant coil was returned without introducer sheath.The concerto coil pushwire was found to be broken at ~143.3cm from proximal end.The distal assembly was found to be broken and not returned.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.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the concerto coil prior to use, and lack of continuous flush during delivery.The model or lot number for the unknown catheter were not provided; therefore, compatibility 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: 19288229
• Report Number: 2029214-2024-00895
• Device Sequence Number: 8693571
• Product Code: KRD
• UDI-Device Identifier: 00847536033733
• UDI-Public: 00847536033733
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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 Expiration Date: 03/12/2026
• Device Model Number: PV-3-6-3D
• Device Catalogue Number: PV-3-6-3D
• Device Lot Number: B531457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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