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

Model Number PED-500-20

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

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 was a kink in the pipeline causing an inability to open about 2-3mm proximal to the distal end.As a result the physician resheathed the device and deployed the device two times but the issue recurred.The system was then replaced and the procedure completed successfully.The patient was undergoing treatment of an unruptured, amorphous right cavernous ica aneurysm with a max diameter of 30mm and a neck diameter of 7mm.It was noted that the patient's vessel tortuosity was severe.There were no additional steps to attempt to open the pipeline.

Manufacturer Narrative

Product analysis findings: the pipeline flex stuck inside the marksman was returned within shipping box; within an opened pipeline flex outer carton; and within a plastic biohazard-pouch.In addition, the tip coil, sleeves, pads and partially distal hypotube were deployed from catheter distal tip.For further examination, the pipeline flex was pushed out of the catheter lumen without any issues.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 were found fully opened and moderately frayed.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and marker were examined; and no damages were found.No kink or damages were found with catheter body.No flash or voids molded were observed in the hub.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open at the distal end as the distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.However, the cause for damage could not be determined.It is possible that the severe vessel tortuosity may have contributed to the failure to open issue.There was no non-conformance to specification identified that led to the failure to open issue.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.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.

Event Description

Additional information received reported that the pipeline was positioned in a vessel bend when it failed to open.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10968825
• MDR Text Key: 220247762
• Report Number: 2029214-2020-01247
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015661
• UDI-Public: 00836462015661
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A764356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 74