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

Model Number	PV-2-6-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 one coil would not advance out of the clear introducer sheath and the second coil would not detach.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
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
Additional information was received.Lesion characteristics included distal gi bleed, left colic artery, 1.5mm diameter.Vessel tortuosity was severe.The devices were prepared as indicated in the ifu.The procedure completed with other coils being utilized.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.3 attempts were made to detach the coil using the instant detacher.No attempts were made to detach the coil using the manual method, the doctor did not want to risk attempting the manual detachment method.Prior to coil non-detachment, the coil negotiated tortuosity through an appropriately sized microcatheter to target of embolization and would not detach.No pushwire damage was observed after removal from the patient.
Additional Manufacturer Narrative
H3: product analysis (b)(4) :equipment used- video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition- the concerto coil was returned for analysis within a shipping box and within a resealable plastic biohazard pouch.The instant detacher used during the event was not returned for analysis.A second concerto coil was returned and will be addressed in pli-10.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube and the break indicator was found unbroken.There was no evidence of detachment attempts found at these locations.The pusher was found bent at ~54.0cm from the proximal end.The coin was found still against the lumen stop.Blood was found under the ptfe shrink tubing and within the lumen stop.The implant coil was found still attached to the pusher.The implant coil was found to be damaged.Testing/analysis ¿ the implant coil failed to detach using an in-house instant detacher and by manual method.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved.The release wire was retracted, and the coin exited the lumen stop, detaching the implant coil with no further issues.No other damages or anomalies were found with the returned device.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachment is the blood found within the lumen stop and under the shrink tubing causing the coin to become stuck within the lumen stop.The pusher and implant coil were found damaged, potentially due to advancing against resistance or during handling/return shipping to medtronic for analysis.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment could not 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19041223
• Report Number: 2029214-2024-00568
• Device Sequence Number: 20638685
• Product Code: KRD
• UDI-Device Identifier: 00847536033719
• UDI-Public: 00847536033719
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

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 Expiration Date: 01/03/2026
• Device Model Number: PV-2-6-3D
• Device Catalogue Number: PV-2-6-3D
• Device Lot Number: B497180
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/18/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/30/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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