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

Model Number	PED-500-25
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the pipeline flex would not open and attach to the wall properly (full wall apposition was not achieved).Repeated attempts to open the distal part of the pipeline were made but without success.There was also mention of pipeline resistance inside the distal segment of the microcatheter.The operation was completed by replacing the pipeline and microcatheter with new pipeline and microcatheter.The pipeline as not placed on a bend.More than 50% of the pipeline was deployed before it opened and the pipeline was resheathed less than or equal to two times.There were no additional steps to open the pipeline.The pipeline was removed from patient by resheathing.Post procedural angiography was moderately distorted (images attached).No patient injury was reported as a result of the event.Second pipeline implanted properly and fully opened.The patient was undergoing embolization treatment of an unruptured fusiform aneurysm measuring 5.25mm x 14.66mm located in the v3-v4 segment of the right vertebral artery.The distal and proximal landing zone was 3.22m x 3.42mm.The vasculature was moderate in tortuosity.Access was by femoral artery.It was unknown if the patient was on dual antiplatelet therapy at the time.There was not any damage to the pipeline pushwire and catheter.
Additional Manufacturer Narrative
For further examination, the pipeline flex was then pushed out from the catheter lumen with difficulty.When compared to the drawing 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 (0.5865 mm).The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid fully opened and moderately frayed.Bends found on the pusher at 17.0 cm to 23.5 cm from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.When compared to the drawings 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 appeared to be stretched and accordioned from 19.5 cm to 29.5 cm from the distal tip.No flash or voids molded were observed in th e hub.The catheter was flushed with water and found to be patent.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 issues; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the analysis findings, the pipeline flex and marksman catheter were confirmed to have resistance during delivery; as the returned pipeline flex was stuck inside the distal segment of the marksman catheter.However, the pipeline flex was not confirmed to have failure to open; as the distal and proximal ends of the returned pipeline flex braid were found fully opened and moderately frayed.The damage on the ends of the braid is likely the results of the physician re-sheathing the device more than recommended two times.In addition, the pipeline flex and the marksman catheter appeared to be damaged.From the damages seen on the catheter body (stretching/accordioning), pusher (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to navigate the pipeline flex through the marksman catheter against resistance.It is possible that the patient tortuous anatomy and lack of continuous flush with heparinized saline may have contributed to the reported issues.There was no device malfunction or non-conformance to specifications identified that led to the resistance during delivery.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. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8607692
• Report Number: 2029214-2019-00458
• Device Sequence Number: 16662816
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 04/18/2021
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A632214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR