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

Model Number PED2-400-20

Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information reporting that during a procedure, two pipeline shield devices had difficulty opening and with positioning.The patient was undergoing a procedure for flow diversion treatment of a ruptured blister aneurysm of the left internal carotid artery (ica) distal supraclinoid.The aneurysm max diameter was 1.6mm and the neck diameter was 1.6mm.Vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered.It was reported that due to the severe tortuosity of the ica, the guide catheter was parked at the ica origin.The navien 5f intracranial support catheter was tracked over the phenom 27 microcatheter to the supraclinoid syphon.At the supraclinoid level, a tight double bend in the vessel was present.The phenom microcatheter was parked at the m2 superior branch and the ped2-400-20 was loaded.The pipeline began opening well at the m1.The physician pulled it back below the terminal ica and the pipeline anchored very well.However, after 8-10mm of the device was deployed, the middle and proximal segment of pipeline were positioned in the bend and did not open and was moving independently in the opposite direction of the catheter.The physician attempted to resheath and redeploy twice but could not resolve the issue or fully resheath, even with attempt to use the navien.The ped2-400-20 was able to be half resheathed and was removed successfully from the patient's body.Once removed, the pipeline still could not be opened on the table.A ped2-400-18 was then introduced and deployment was attempted from the mid m1 to the proximal ica.This pipeline also opened well at the distal end but failed to open at the distal supraclinoid.Tried resheathing 3 times without resolving the issue.The physician deceived to remove the pipeline and end the procedure but while withdrawing the device, the physician was unaware the pipeline had be deployed from the phenom beyond the resheathing marker and the device proximal end opened in the navien.The pipeline was half deployed in the patient's ica proximal to the aneurysm and half deployed in the navien.Attempts to recapture the pipeline with a snare were unsuccessful to it was implanted, fully open, in the patient's ica without coverage of the aneurysm.The case was then abandoned.It was noted there was moderate friction with the pipelines and the phenom catheter during the procedure.The pushwire was not rota ted or pulled back at any time.All devices were prepared and the catheter flushed as indicated in the instructions for use (ifu).There were no patient symptoms or complication associated with the event.Post-procedure angiography results showed the ped2-400-18 fully open proximal to the aneurysm.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex shield was returned within the inner pouch; inside of a biohazard bag and a shipping box.Visual inspection/damage location details: 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 shield braid were fully opened and frayed.The middle section of the braid was found fully opened with no damage.No bend found on the pusher.No damages were found with tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.Conclusion: based on the returned device, the customer complaint was not confirmed as the pipeline flex shield braid was fully opened and frayed at both ends.The damage to the braid on the ends of the pipeline flex shield is likely the results of the physician re-sheathing the device more than recommended two times.It is possible that the severe vessel tortuosity may have contributed to the reported issues.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex shield embolization device has successfully expanded, deploy the remainder of pipeline flex shield embolization device by pushing the delivery wire and/or unsheathing the pipeline flex shield 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 shield 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 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.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12233479
• MDR Text Key: 264151000
• Report Number: 2029214-2021-00935
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: PED2-400-20
• Device Catalogue Number: PED2-400-20
• Device Lot Number: B037650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 59 KG