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

Model Number	PED-450-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
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: 2029214-2019-01187 and 2029214-2019-01188.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of pipeline flex incomplete opening during a procedure.Information that pipeline flex device flattened and stretched during the procedure.The pipeline did not open.Fistula happened during advancement of the navien and phenom 027 in an attempt to open the flattened area.The patient was undergoing embolization treatment for an unruptured amorphous aneurysm located in right internal carotid artery (ica) landing zone distal 3.2mm proximal 4.7mm.The vessel was observed moderately tortuous.It was reported that pipeline was prepped per ifu, no issues during deployment.Pipeline did appear to be stretching before detachment and was detached over a bend which resulted in flattening of the device.The physician advanced a guide catheter and microcatheter to open the flattened area.A run with contrast revealed a fistula that the physician believes was catheter induced.The physician decided to ¿sack¿ the vessel as the right ica on imaging was being well fed from contralateral flow.Right ica was sacrificed; the patient¿s contralateral flow was feeding right circulation.There were no patient symptoms or complications associated with this event.

• 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: 9407255
• Report Number: 2029214-2019-01186
• Device Sequence Number: 19477846
• Product Code: OUT
• UDI-Device Identifier: 00847536016415
• UDI-Public: 00847536016415
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 06/17/2021
• Device Model Number: PED-450-16
• Device Lot Number: A662356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR