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

Model Number PED2-450-12

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that there were two trials to deploy a pipeline device.In the first the physician attempted to deploy the pipeline in a phenom 27 microcatheter during which the deployment was good but the distal part did not open.During adjustment of this the pipeline dropped down proximally and it was impossible to get it back to the deployment position.In the second trial with the marksman catheter the proximal end ruptured due to resistance.As a result the device was replaced with one of another manufacturer.The patient was undergoing surgery to treat an unruptured, saccular opthalmic aneurysm.Dual antiplatelet treatment was administered with a pru level of 21%.The pipeline was prepared as indicated per the ifu.

Manufacturer Narrative

The pipeline flex with shield stuck inside the marksman catheter, within a sealed biohazard plastic bag and inside of a shipping box.The marksman catheter appeared to be separated into two segments.For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty.A moderate 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 to be within specifications (~0.5865mm).The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire at 24.0 cm to 33.0 cm from the proximal end.The distal and proximal ends of the pipeline flex shield braid fully opened and moderately frayed.No defects were found with the tip coil, distal marker, re-sheathing marker or with the p roximal 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 stretched at 3.5 cm to 9.0 cm; and accordioned at 18.5 cm to 30.0 cm from the distal tip.The catheter body also observed to be accordioned at 7.5 cm to 13.0 cm from the proximal end of the hub.In addition, the catheter body separated at 29.5 cm from the distal tip.The broken ends of the catheter exhibited with stretching and necking.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 damaged locations.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7934064
• MDR Text Key: 122662566
• Report Number: 2029214-2018-00826
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2019
• Device Model Number: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: A326841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR