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

Model Number	NV-6-20-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding three concerto coils that had difficulty detaching with 2 different instant detachers and standard manual method/hypotube.It was reported that during a splenic embolization procedure, the first concerto coil was implanted and detached normally. the second concerto coil would not detach with the instant detacher (id) so manual detachment was attempted but was also unsuccessful.Finally, the physician pulled the "string" in its entirety after which time the coil was still attached and only detached when the physician attempted to remove it and it got back to the catheter at which time it detached.The coil was then able to be implanted at the intended location.The radiologic technologist thought it was possible the id was the problem and a new id was opened to try with the remaining 2 coils.However, the new id also did not with the last 2 coils and they were both detached using the same method as the previous coil, pulling back to the catheter.All the coils were ultimately implanted successfully at the intended location.The procedure was successful and the patient was not harmed.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11546165
• Report Number: 2029214-2021-00323
• Device Sequence Number: 4140468
• Product Code: KRD
• UDI-Device Identifier: 00847536033573
• UDI-Public: 00847536033573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 12/08/2023
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: B128946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1