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

Model Number	PED-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Nerve Damage (1979); Occlusion (1984); Paralysis (1997)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pipeline flex 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.Mdrs related to this event: 2029214-2018-00713.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of intraprocedural pipeline flex failure to open as well as vessel occlusion.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 20 mm and neck diameter was 11 mm.The landing zone was 3 mm distal and 4.9 mm proximal.The patient had been administered dual antiplatelets and was within the therapeutic range.The devices were prepared as indicated in the ifu.A pipeline flex 5 x 30 mm was attempted to be placed.The pipeline flex reportedly did not open on the distal end when initially deployed.After full deployment, the proximal end was also flattened.When capturing the delivery wire, the catheter was used to open up the flattened proximal section of the pipeline flex.To open the distal end, a j-curve wire was used then balloon angioplasty, which resulted in the pipeline flex opening and apposing to the vessel wall.When the balloon was deflated, the vessels distal to the pipeline flex (pcom, distal ica, anterior cerebral artery) were occluded.A balloon was inflated at the occlusion site to open the distal ica.Afterward, an aspiration catheter was passed several times removing clot.A reopro bolus was administered and a continuous drip was set up.Image runs were performed over a period of 30-45 minutes to determine effectiveness of the reopro.At the end, some branches of the aca and right pcom were not filling when the patient was removed from the table.The next day, the patient was not moving on the left side.The patient reportedly experienced nerve palsy.

• 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: 7779521
• Report Number: 2029214-2018-00714
• Device Sequence Number: 1230983
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: PED-500-30
• Device Lot Number: A486746
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 32 YR