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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the concerto coil prematurely detached during approach to the microcatheter.The device was replaced, and the event was said to be not associated with the patient. the devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
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: analysis of pv-12-30-helix (lot# b327537) pushwire found the implant coil to be detached from the pushwire.The shield coil appeared to be stretched.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire.The ai and coupler tubing were found intact with no damage.Bends were found at 8.0cm to 30.0cm from the proximal end of the pushwire.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00268¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00461¿ and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.Based on the analysis performed, the concerto coil was confirmed to have "premature detachment" issue as the pushwire was returned with the implant coil already detached from the pushwire.The pushwire was bent at several locations.In addition, the pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.However, the cause could not be determined.There was no non-conformance to specification identified that that led to the reported issue.Since the implant coil was not returned; any cont ribution of the implant coil to the premature detachment 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
Additional information received reported that the ¿detached coils was delivery from used to guide wire.¿ no concerto coil was detached before detachment attempt.Pushwire condition <(>&<)> delivery status was perfected.Pre-detached coil was implanted to patient.
Additional Manufacturer Narrative
H3: product analysis # (b)(6):¿ equipment used: video inspection system (m-85519) with microscope, ruler (m-83361), camera (panasonic lumix dmc-zs5) ¿ drawing(s) referenced: dwgs50566 rev.A; dwgs50520 rev.T; dwgs31195 rev.B; dwgs50523 rev.E ¿ as found condition: the pushwire was returned for analysis within the outer carton; inside of a biohazard bag and a shipping box.There was no implant coil returned with the pushwire.¿ visual inspection/damage location details: the implant coil was found to be detached from the pushwire.The shield coil appeared to be stretched.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire.The ai and coupler tubing were found intact with no damage.Bends were found at 8.0cm to 30.0cm from the proximal end of the pushwire.¿ testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.087mm @ 0.127mm; measured 0.095mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00268¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00461¿ and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ conclusion: based on the analysis performed, the concerto coil was confirmed to have "premature detachment" issue as the pushwire was returned with the implant coil already detached from the pushwire.The pushwire was bent at several locations.In addition, the pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.However, the cause could not be determined.There was no non-conformance to specification identified that that led to the reported issue.Since the implant coil was not returned; any contribution of the implant coil to the premature detachment could not be determined.Ls 2022-11-10 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: 15432423
• Report Number: 2029214-2022-01563
• Device Sequence Number: 12267075
• Product Code: KRD
• UDI-Device Identifier: 00847536033627
• UDI-Public: 00847536033627
• 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,Followup,Followup
• Report Date (Section B): 03/31/2023

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: 01/23/2025
• Device Model Number: PV-12-30-HELIX
• Device Catalogue Number: PV-12-30-HELIX
• Device Lot Number: B327537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 03/29/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/17/2022; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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