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

Model Number PED-500-35

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2021-00754 for the other pipeline involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two pipeline devices failed to open in the middle and proximal sections.The patient was undergoing treatment for an amorphous, direct carotid-cavernous fistula in the left ica due to blunt force trauma.The patient's vessel tortuosity was severe.The landing zone was 7mm distal and 10mm proximal.The access vessel was the ica, which was 5mm in diameter. dual antiplatelet treatment was administered.It was reported that pipeline had trouble coming through the acute turn of the anterior genu.They continued trying to deploy, hoping that with wagging, loading, and centering the device might start to open more.At one point it looked like it was opening, but was ribboning/flattening too.The pipeline was not positioned in a bend when it failed to open, and more than 50% had been deployed at the time.The physician resheathed the pipeline two or less times, and no additional steps were taken to open the device.The physician replaced the pipeline, but to the same thing happened with the new device.The physician removed this pipeline and tried with two stryker evolve devices, but similar deployment issues occurred. they decided to complete deployment and balloon angioplasty.Angiographically, they were able to accomplish their goal.There was nothing visibly wrong or issues alleged with the microcatheter. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a cook 6fr shuttle sheath, navien 058 guide catheter, phenom 27 microcatheter, and synchro 2 guidewire.

Manufacturer Narrative

H3: the distal and proximal ends of the pipeline flex braid were found fully opened and frayed.The middle section of the braid appeared fully opened and no damage.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open issue.The root cause could not be determined as the pipeline flex was found fully opened and frayed at both ends.The damage to the braid on the ends of the pipeline flex is likely the results of the physician re-sheathing the device more than recommended two times.It is likely that the severe vessel tortuosity may have contributed to the failure to open issue.There was no non-conformance to specifications identified that led to the reported issues.Per our 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.Resheathing 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.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.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 steno sis.¿ 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.

• 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: 12036297
• MDR Text Key: 263444193
• Report Number: 2029214-2021-00755
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B099589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76