MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

Model Number PED2-400-18

Device Problem Activation Failure (3270)

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

Event Date 09/11/2020

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 the first pipeline failed to open, and the second pipeline had resistance during delivery.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.It was reported that the pipeline stent did not open in the distal portion but also the proximal section.The proximal section was positioned in a bend, less than 50% was deployed, resheathing was done less than 3 times, and no additional steps were taken to open the stent.The physician removed the pipeline, and used a second pipeline for the procedure.During delivery of the second pipeline, there was resistance in the proximal section of the marksman microcatheter.However, the second pipeline was still able to be impl anted successfully.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed satisfactory results.

Event Description

Additional information was received clarifying that it was just the distal end of the pipeline that failed to open.There was no damage observed to the pipeline pushwire or the catheter.

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.

Manufacturer Narrative

H3: the pipeline flex shield was returned stuck inside the marksman catheter.The pipeline flex shield could not be pushed forward or removed.For further examination, the marksman catheter was cut to remove the pipeline flex shield delivery system.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 appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex shield braid were found fully opened and frayed.Bends were found at 10.0cm to 35.5cm from the proximal end.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 marksman catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body accordioned at 19.0cm to 30.0cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex shield and marksman catheter were confirmed to have ¿resistance during delivery¿ and ¿catheter resistance¿ issues.The returned pipeline flex shield was found stuck inside the marksman catheter.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex shield (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex shield through the marksman catheter against the reported resistance.In regarding to the "failure to open" issue, the pipeline flex shield was not confirmed as the distal and proximal ends of the pipeline flex shield braid were fully opened and moderately frayed.The damage to the braid on the ends of the pipeline flex shield braid is likely the results of the physician re-sheathing the device more than recommended two times.It is likely that the patient¿s severe vessel tortuosity and lack of continuous flush with heparinized saline may have contributed to the resistance during delivery.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.Re-sheathing the pipeline flex shield 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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10544579
• MDR Text Key: 207332148
• Report Number: 2029214-2020-00936
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: A839468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 02/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 70