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

Model Number	PED-375-35
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
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, once in place, the physician attempted to open the pipeline device but it would not open and could "not be fully attached." the physician continued to release the device up until the middle of the neck but the tip still wouldn't fully open, with the entire pipeline system eventually slipping into the aneurysm sac because the pipeline tip was not fully attached.As a result the pipeline was withdrawn and replaced with another of the same model, allowing the operation to be completed as intended.The patient was undergoing surgery to treat an unruptured, saccular aneurysm with a max diameter of 29mm and a neck diameter of 19mm.Dual antiplatelet treatment was administered, and post procedure angiographic imaging showed blood stasis.It was noted that the patient's vessel tortuosity was moderate.There were no related patient symptoms.The devices were prepared as indicated per the ifu.Ancillary devices include a marksman microcatheter.
Additional Manufacturer Narrative
The pipeline flex within the catheter was returned for evaluation.The pipeline flex was then pushed out from the catheter lumen without difficulty.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.The distal and proximal ends of the pipeline flex braid appeared to be fully opened and no damage.No bends were observed on the pushwire.No damages were found with the catheter, tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the analysis findings, the customer complaint could not be confirmed.The event cause could not be determined as the returned pipeline flex braid found to be fully opened and no damage.In addition, no damages were found with the returned pushwire and catheter.It's possible that the "patient tortuous anatomy" may have contributed to the reported issues.The customer reported that the devices were prepared per the ifu.In addition, the patient vessel tortuosity was moderate.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested; therefore, a device history record review was not performed.Per the instructions for use: the user should "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.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.¿ all products are 100% inspected for damages and irregularities during manufacture.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• 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: 8118324
• Report Number: 2029214-2018-01003
• Device Sequence Number: 243803
• Product Code: OUT
• UDI-Device Identifier: 00847536015753
• UDI-Public: 00847536015753
• 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): 03/01/2019

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: 04/25/2021
• Device Model Number: PED-375-35
• Device Catalogue Number: PED-375-35
• Device Lot Number: A636146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1