MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-475-14
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-01098 2029214-2019-01099 2029214-2019-01100.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of carotid cavernous fistula during a procedure.The patient was undergoing treatment of an unruptured aneurysm in the internal carotid artery (ica.) anatomy was reportedly very tortuous.The devices were prepared and used per the instructions for use (ifu).It was reported that during the procedure, a pipeline flex was attempted to be placed.During advancement of the pipeline flex, a large amount of force was required through the distal section of the phenom catheter.The procedure was abandoned and a carotid cavernous fistula (ccf) was noted.The ccf was coiled.The patient did not experience a neurological decline from baseline.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9268971
• Report Number: 2029214-2019-01099
• Device Sequence Number: 1951403
• Product Code: OUT
• UDI-Device Identifier: 00847536016651
• UDI-Public: 00847536016651
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: PED-475-14
• Device Lot Number: A873205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR