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

Model Number	PED-300-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of pipeline flex pushwire detachment during a procedure.The patient was undergoing treatment for an unruptured, saccular aneurysm in the basilar artery.The aneurysm max.Diameter was 4mm and neck diameter was 4mm.Vessel tortuosity was described as minimal.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the pipeline flex was deployed successfully.During recapture of the delivery system, the microcatheter was advanced through the pipeline flex braid at which time the wire became detached inside the catheter.The detached portion of the delivery system (from the proximal bumper to the tip coil) remained in the left posterior cerebral artery.Two additional pipeline devices were placed to secure and cover the entire detached wire.The post-procedure angiographic result was reportedly good; the basilar artery and left pca were patent.The patient has not experienced any symptoms or complications.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8036489
• Report Number: 2029214-2018-00909
• Device Sequence Number: 1463658
• Product Code: OUT
• UDI-Device Identifier: 00847536014763
• UDI-Public: 00847536014763
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: PED-300-14
• Device Lot Number: A668536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/04/2018
• 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