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

Model Number	PED-450-25
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that pipeline flex device did not open during the procedure.The patient underwent embolization treatment with flow diversion for a small unruptured saccular right ophthalmic artery aneurysm, measuring 9.33mmx4.27mm.Landing zone distal 2.59mm proximal 4.51mm.The vessel was moderately tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.It was reported the tip of this pipeline stent cannot be opened.During procedure, the physician tried to open the tip of the pipeline in the middle segment of the middle cerebral artery of a straight blood vessel, but it was unsuccessful.The pipeline re-sheathed, and the tip was released again.Then tried to pull the end of the stent to the end of the internal carotid artery, and the system gave tension.After many attempts, it still cannot be opened.The tip of the pipeline braid frayed.There was no way to withdraw the stent.The pipeline flex could not be resheath as the pipeline flex braid was stuck on the dps sleeves.The pipeline resheathed and removed with the microcatheter.There were not any patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
D10: device available for evaluation: additional information.G4.Date mfr rec: additional information.H2: type of follow up.Device evaluation: h3: device evaluated by manufacturer: additional information.H6: codes updated.The device was returned for evaluation and the clinical observation could not be confirmed.As received, the pipeline flex stuck inside the medtronic catheter.The pipeline flex was then pushed out from the catheter lumen with difficulty.The distal and proximal ends of the pipeline flex braid fully opened and moderately frayed.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 appeared to be stretched with the ptfe shrink tubing still intact.Bends found on the pusher at multiple locations from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.We were unable to determine the cause of pipeline flex device of failure to open during the procedure as returned pipeline braid 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.It is possible that the patient tortuous anatomy may have contributed to the failure to open and resheathing issues.Per instructions for use (ifu), ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is n ot fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8547691
• Report Number: 2029214-2019-00377
• Device Sequence Number: 18910496
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 11/09/2021
• Device Model Number: PED-450-25
• Device Lot Number: A738467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR