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

Model Number	PED-500-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device will not be returned for evaluation; it was reportedly lost.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: 2029214-2018-00713, 2029214-2018-00714.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that a pipeline flex device did not open during a procedure.The patient was undergoing flow diversion treatment of an unruptured, amorphous aneurysm in the right, cavernous internal carotid artery (ica).Vessel tortuosity was described as severe.The aneurysm max.Diameter was 20mm and neck diameter was 11mm.The landing zone was 3mm distal and 4.9mm proximal.The patient had been administered dual antiplatelets and was within the therapeutic range.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the guide catheter and catheter were placed in the right posterior communicating (pcom) artery.A pipeline flex 5x25mm was advanced through the catheter.At deployment, the pipeline flex was unsheathed by pulling back the catheter and pushing the device out; it was reported that the tip wire became "stuck" on a side branch in the pcom artery.The catheter and pipeline flex were pulled back to the ica and deployment continued.The tip wire reportedly became stuck on the distal ica stenosis; being unable to reposition, deployment continued.It was reported that the distal end of the pipeline flex did not completely open, despite resheathing.The decision was made to continue deployment.The pipeline opened normally until reaching the curve proximal to the aneurysm - the device remained flattened despite repositioning the device by pushing forward on the system and pulling back on the system to reposition it along the inner wall.The pipeline flex was removed from the patient.Ultimately, a new pipeline flex was used to complete the procedure.

• 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: 7779516
• Report Number: 2029214-2018-00713
• Device Sequence Number: 1258581
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 04/07/2019
• Device Model Number: PED-500-25
• Device Lot Number: A257138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR