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

Model Number	PV-5-15-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
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 through regulatory body that the physician was using a concerto detachable coil system during the procedure, but when he tried to deploy the coil, the system failed and did not work.Unable to deploy a coil during the procedure due to the system being defective.The patient was undergoing surgery for treatment of an aneurysm of the right hepatic artery.

• Brand Name: DEVICE, EMBOLIZATION, ARTERIAL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9161331
• Report Number: 2029214-2019-00976
• Device Sequence Number: 19440590
• Product Code: KRD
• UDI-Device Identifier: 00847536026384
• UDI-Public: 00847536026384
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 09/24/2021
• Device Model Number: PV-5-15-3D
• Device Catalogue Number: PV-5-15-3D
• Device Lot Number: A713200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR