MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-450-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the head of the pipeline wouldn't open.Three attempts were then made to return the pipeline to the microcatheter and open the device again but the head wouldn't open.As a result the device was replaced with another of the same model which opened freely allowing the operation to be complete successfully.The patient was undergoing surgery to treat an unruptured, saccular aneurysm with a max diameter of 7.6mm and a neck diameter of 5.3mm.It was noted that the vessel tortuosity was moderate.It was confirmed that dual antiplatelet treatment was administered and the devices were prepared and flushed as indicated per the ifu.Post procedure angiographic results showed that the blood flow had slowed down.There were no related patient symptoms.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The cause of the issue was not determined?.
Additional Manufacturer Narrative
The pipeline flex was returned for evaluation within its outer carton; inside of a sealed bio-hazard bag and a shipping box.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bends were observed on the pushwire.The distal and proximal ends of the pipeline flex braid appeared fully opened and no damage.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7698127
• Report Number: 2029214-2018-00631
• Device Sequence Number: 1553998
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2018

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: 04/08/2021
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: A626148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 09/07/2018; 08/08/2018; 10/01/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/07/2018; 10/05/2018; 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1