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

Model Number	NV-3-8-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the concerto coil was returned within a shipping box and within a sealed biohazard pouch.Visual inspection/damage location details: the concerto coil was returned without the introducer sheath.The pusher was found to be bent at approximately 145.0cm from the proximal end.The concerto implant coil appeared to be broken and detached from the pusher and not returned for analysis.No other anomalies were observed.Testing analysis: the concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck at catheter hub¿ was confirmed.The concerto implant coil was broken off the distal end of the pusher and not returned for analysis.In addition, the pusher was found bent.The concerto coil can become damaged if advanced against resistance.Possible causes for resistance at catheter hub are, but not limited to failure to use a compatible microcatheter for delivery, improper hubbing technique (sheath not properly seated in hub/excessive tightening of the rhv), or catheter hub transition.Improper hubbing technique could not be ruled out as a potential cause.The model and lot numbers for the microcatheter used in the event were not provided; therefore, compatibility could not be assessed.Since the catheter wasn¿t returned, an analysis could not be performed.The root cause of the resistance could not be determined.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.
Event or Problem Description
Medtronic received a report that the coil was stuck at the catheter hub.No patient symptoms or further complications were reported as a result of this event.The reported device and any accessory devices were prepared as indicated in the ifu.
Additional Manufacturer Narrative
H3: the concerto coil was returned without the introducer sheath.The pusher was found to be bent at ~145.0cm from the proximal end.The concerto implant coil was not returned for analysis.No other anomalies were observed.The concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck at catheter hub¿ was not confirmed as the coil appeared to be prematurely detached from the pusher.The cause could not be determined.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.
Additional Manufacturer Narrative
H3: product analysis of nv-3-8-helix, lot# b321222 as found condition: the concerto coil was returned within a shipping box and within a sealed biohazard pouch.Visual inspection/damage location details: the concerto coil was returned without the introducer sheath.The pusher was found to be bent at 145.0cm from the proximal end.The concerto implant coil appeared to be broken from the distal end of the pusher and not returned for analysis.No other anomalies were observed.Testing analysis: the concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck at catheter hub¿ was confirmed.The concerto implant coil was broken off the distal end of the pusher and not returned for analysis.In addition, the pusher was found bent.The concerto coil can become damaged if advanced against resistance.Possible causes for resistance at catheter hub are, but not limited to failure to use a compatible microcatheter for delivery, improper hubbing technique (sheath not properly seated in hub/excessive tightening of the rhv), or catheter hub transition.Improper hubbing technique could not be ruled out as a potential cause.The model and lot numbers for the microcatheter used in the event were not provided; therefore, compatibility could not be assessed.Since the catheter wasn¿t returned, an analysis could not be performed.The root cause of the resistance could not be determined.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 NYLON
• 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: 15670531
• Report Number: 2029214-2022-01805
• Device Sequence Number: 6421567
• Product Code: KRD
• UDI-Device Identifier: 00847536033528
• UDI-Public: 00847536033528
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 01/10/2025
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: B321222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 03/30/2023; 05/03/2023
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 04/11/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown