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

Model Number	PV-3-8-3D
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was resistance with 4 concerto coils and the coil wouldn't detach.The patient was undergoing treatment for prostatic artery embolization (pae).The patient's blood flow and vessel tortuosity were normal.It was reported that two coils were stuck in the proximal part of the microcatheter, one was stuck in the catheter hub, and one was stuck in the distal part of the catheter. the coils had pushed out of the introducer sheath smoothly.There was no damage to the catheter or coils. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
See manufacturer report # 2029214-2022-00820 and 2029214-2022-00821 for other coils involved in this event.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: as found condition: the concerto coil was returned for analysis within a shipping box; within primary and secondary plastic bio-pouches; within an opened concerto outer carton and within a dispenser coil.Information regarding the micro catheter was used in the event was not reported (model and lot number).Therefore, any contributing factors could not be assessed.Visual inspection/damage location details: the concerto implant coil was returned within the introducer sheath.No bent or kink were found with concerto pushwire.The concerto implant coil was still attached to the pushwire.The concerto implant coil was found damaged within introducer sheath.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: the concerto implant coil was unable to pushed out from introducer sheath, therefore the implant coil was pulled out proximally.The concerto coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Conclusion: based on the analysis performed, the customer report of ¿catheter resistance/stuck in catheter¿ was confirmed.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, damage/kink to pushwire and lack of continuous flush during delivery.The concerto implant coil was found damaged.It is likely that the damage to the concerto implant coil occurred during the attempt to push the coil through the micro catheter against the reported resistance.The vessel tortuosity was normal.Other possible causes for coil/pushwire damage are: lack of hydration before procedure, user does not maintain continuous flush.It was reported all devices were prepared as per the instructions for use (ifu).Since the micro catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.As the model and lot number of the micro catheter was not reported, compatibility could not be assessed.There was no non-conformance to specification identified that led to the reported issues.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 was received indicating that one of the coils failed to detach.The cause of the issue was believed to be due to an issue with the catheter.The catheter was a boston scientific tru select.

• 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: 14399492
• Report Number: 2029214-2022-00822
• Device Sequence Number: 5551336
• Product Code: KRD
• UDI-Device Identifier: 00847536033740
• UDI-Public: 00847536033740
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/06/2022

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: 12/15/2024
• Device Model Number: PV-3-8-3D
• Device Catalogue Number: PV-3-8-3D
• Device Lot Number: B313565
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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