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

Model Number	NV-7-30-HELIX
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil was returned for analysis.The concert coil was found to be detached from the pushwire.The concerto implant coil and pushwire were then decontaminated.No bends or kinks were found with the coil¿s pushwire.The coin was found against the lumen stop.The coil shied was found intact.The concerto implant coil was found damaged and had lost its original shape.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿poor lay up or framing¿ could not be confirmed.Possible causes of failure include patient vessel tortuosity, catheter kick back, high blood flow, or incorrect sizing of implant.The patient¿s vasculature was minimal in tortuosity, the blood flow was normal, and the catheter was not under stress.It¿s possible the damage to the implant coil contributed to the event; however, the cause for the event could not be determined.Per the concerto coil instructions for use (ifu): warning: "if the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break.Gently remove and discard both the catheter and coil." information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the concerto coil did not form a loop, when it was deployed.The coil appeared straight and only moved forward.The coil was retrieved and redeployed several times but still failed to form a loop.The coil was removed and discarded.A new coil was selected and used to treat the patient.The max diameter was 2cm and the neck was 6mm.No patient injury occurred.The patient was undergoing embolization treatment of an unruptured saccular aneurysm located in the splenic artery.The patient¿s vasculature was minimal in tortuosity and the blood flow was normal.The coil was not implanted in the intended location and the device did not jump during deployment.The vessel was not damaged and the catheter was not under stress.

• 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: 8647857
• Report Number: 2029214-2019-00488
• Device Sequence Number: 1845483
• Product Code: KRD
• UDI-Device Identifier: 00847536013643
• UDI-Public: 00847536013643
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: 06/08/2020
• Device Model Number: NV-7-30-HELIX
• Device Lot Number: A473497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 58