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

Model Number PED2-425-18

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline device that failed to open at the distal end and the protective sleeves were stuck.The patient was undergoing a procedure for telescoped ped's to treat an unruptured saccular aneurysm of an ophthalmic segment of an interior carotid artery.The aneurysm max diameter was 6mm and the neck diameter was 5mm.Patient vessel tortuosity was normal.It was reported that all devices were prepared as indicated in the instructions for use (ifu).More than 50% of the pipeline stent was deployed when it was noted that the distal end of stent failed to open.The stent was resheathed and redeployed more than two time and continued to fail.The physician attempted to use a wire or catheter to coax the stent to open, but their maneuver was also unsuccessful.It was noted that the sleeves seemed to be stuck.Finally, after multiple unsuccessful attempts to open the pipeline, it was resheathed and removed from the patient.Other peds were successfully implanted in the patient.There was no harm or injury to the patient.Post-procedure angio revealed good results.

Manufacturer Narrative

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 marksman microcatheter was replaced with a phenom microcatheter.There was no damage observed to the pipeline stent or pushwire after removal from the patient, and there was no damage observed to the marksman microcatheter.The healthcare professionals stated that it was not possible to get the distal part of the stent open although maneuvers with researching.The manufacturer representative saw that also on the monitors.The sleeves were into the stent, and the catheter worked well.

Manufacturer Narrative

The dps sleeves were found intact and fully opened 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 no damage.No bend found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No damage was found with the marksman catheter.No other anomalies were observed.Based on the returned device, the pipeline flex shield was not confirmed to have "failure to open at the distal end" and "ped stuck on dps sleeves" issues.The root cause could not be determined as dps sleeves appeared fully opened and no damage.In addition, the distal and proximal ends of pipeline flex shield braid were also fully opened and no damage.Possible cause includes patient tortuous anatomy.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 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 shield 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.¿ 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
• MDR Report Key: 10471818
• MDR Text Key: 204939987
• Report Number: 2029214-2020-00867
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: PED2-425-18
• Device Catalogue Number: PED2-425-18
• Device Lot Number: B008212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR