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

Model Number	PV-2-4-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coils became stuck in the catheter. healthcare provider (hcp) used progreat lambda 1.9.Inner d iameter is 0.017", medtronic requires 0.0165".The coil issues were experienced on (b)(6) 2023; however it was not specified which coils were used at each specific procedure as it was reported as a single event.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
H3: product analysis of pv-2-4-3d, lotno:b443212 found due to the condition in which the concerto coils were returned it was unable to be determined which coil belongs to which pli.(coil 1) the concerto coil pushwire was found to be kinked at 56.7cm and kinked at 180.3cm 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.(coil 2) 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 damaged within introducer sheath.The concerto coil was unable to be pushed out for further analysis as it was found to be stuck within introducer sheath.The shield coil was found to be intact.All other subassemblies appeared to be normal, and no other anomalies were observed.(coil 3) the concerto coil pushwire was found to be bent at 7.0cm from proximal end.The implant coil was found to be broken and not returned.The shield coil was found to be intact.All other subassemblies appeared to be normal, and no other anomalies were o bserved.(coil 4) the concerto coil pushwire was found to be kinked at 153.1cm from proximal end.The implant coil was found to be broken and not returned.The shield coil was found to be stretched.All other subassemblies appeared to be normal, and no other anomalies were observed.(coil 5) no bends or kinks were found with the concerto coil pushwire.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.(coil 6) the concerto coil pushwire was found to be bent at 32.0cm, kinked at 145.5cm and at 171.3cm from proximal end.The impla nt coil was found to be stretched and damaged.The shield coil was found to be stretched.All other subassemblies appeared to be normal, and no other anomalies were observed.(coil 7) the concerto coil pushwire was found to be broken at break indicator, kinked at 109.0cm and at 142.6cm from proximal end.The implant coil was found to be detached and not returned.The shield coil was found to be intact.All other subassemblies appeared to be normal, and no other anomalies were observed.(coil 8) the concerto coil pushwire was found to be kinked at ~ 39.5cm for ~7.4cm from proximal end.The implant coil was found to be detached and not returned.The shield coil was found to be stretched.All other subassemblies appeared to be normal, and no other anomalies were observed.(coil 9) the concerto coil pushwire was found to be bent at ~ 67.7cm and bent at 111.0cm from proximal end.The implant coil was found to be stretched and damaged.The shield coil was found to be stretched.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.Conclusion: based on the device analysis and the reported information, the customers report of ¿catheter resistance¿ 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 (terumo) progreat lambda catheter was not returned for analysis.The minimum id (inner diameter) of the progreat lambda catheter is 0.019¿, as per an online source.Per the concerto coil ifu (instructions for use), the minimum catheter id required for use is 0.0165¿.Therefore, the progreat lambda catheter is compatible for use with the concerto coils and can therefore be ruled out as a potential cause.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18905540
• Report Number: 2029214-2024-00440
• Device Sequence Number: 18114652
• Product Code: KRD
• UDI-Device Identifier: 00847536045088
• UDI-Public: 00847536045088
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/14/2024

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
• Device Expiration Date: 07/24/2025
• Device Model Number: PV-2-4-3D
• Device Catalogue Number: PV-2-4-3D
• Device Lot Number: B443212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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
• Patient Sex: Unknown