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

Model Number	PV-12-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of pv-12-30-helix, lotno:b673768 damage location details: the concerto implant coil was returned within an introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was broken at ~8.1cm from the proximal end; however, the pushwire was found to be bent within the introducer sheath at ~124.3cm from the distal end.The concerto implant coil was found to be detached from the pushwire damage (broken with the release wire pulled).In addition, no signs of damage were found near the detach element on the pushwire.The concerto implant coil was not able to be pushed out of the introducer sheath without causing any more damage.No other anomalies were observed.Testing/analysis (including sem reports): the concerto implant coil was unable to be tested with an in-house microcatheter due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance¿ was confirmed.The concerto implant coil was returned with the pushwire damaged (broken, bent), and the implant coil detached (implant coil not returned).Advancing the coil against resistance could lead to possible damage which may cause resistance within the introducer sheath.In addition, there was no sign of damage to the detach element on the pushwire, indicating that the implant coil was caused to detach from the release wire being pulled; however, the root cause for resistance was unable to be determined.The customer report of ¿stuck in catheter¿ was unable to be confirmed.No microcatheter was returned for further assessment.Possible causes for resistance are but are not limited to an incompatible catheter, lack of hydration before a procedure, user does not maintain continuous flush, tortuosity anatomy, and damage or kink to pushwire.Information regarding whether a continuous flush was administered during the procedure was not reported.The customer reported device and any accessory devices were prepared as indicated in the ifu.There was no noted information about patient blood flow or vessel tortuosity provided.No information (lot number, serial number, make, or model) regarding the microcatheter used in the procedure was provided by the customer; therefore, any contribution to resistance caused by the microcatheter was unable to be assessed.The cause for resistance ¿stuck in catheter¿ was unable to be determined.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 concerto coil could not be advanced in the attempts to use it.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).

• 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: 19347737
• Report Number: 2029214-2024-00940
• Device Sequence Number: 6680163
• Product Code: KRD
• UDI-Device Identifier: 00847536045002
• UDI-Public: 00847536045002
• 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
• Report Date (Section B): 05/17/2024

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-12-30-HELIX
• Device Catalogue Number: PV-12-30-HELIX
• Device Lot Number: B673768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: Unknown