MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; 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	06/27/2018
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 distal end of the stent couldn't be opened when pushed from the microcatheter, affecting the shape of the stent.It was noted that there was a difficulty in navigation and friction during delivery of the catheter, and that less than 50% of the pipeline had deployed when it failed to open.The patient was undergoing aneurysm interventional therapy for an unruptured, saccular aneurysm with a max diameter of 5mm and a neck diameter of 4mm.The vessel tortuosity was moderate with an access diameter of 6mm.The devices were prepared as indicated and flushed per the ifu with the pipeline resheathed less than or equal to 2 times.The angiographic result post procedure showed complete embolization.There were no patient symptoms alleged.
Additional Manufacturer Narrative
The pipeline flex delivery system stuck inside the distal segment of the marksman catheter was returned for evaluation within its inner pouch; inside of a sealed bio-hazard bag and a shipping box.For further examination, the pipeline flex delivery system was then pushed out from the catheter lumen with force.A minimal amount of blood was observed inside the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications (0.5839mm).The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened with no damage.The pushwire appeared to be bent at 26.5 cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and the marker band were examined and no damages were found.The catheter body was found to be accordioned at 20.5 cm to 30.0 cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issue; however, resistance was observed at the accordioned locations.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: 7651171
• Report Number: 2029214-2018-00589
• Device Sequence Number: 1433119
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• 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
• Report Date (Section B): 09/28/2018

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: 12/10/2020
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A568388
• 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: 06/27/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR