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

Model Number PED2-500-20

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/20/2022

Event Type  malfunction  

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

Medtronic received a report that the pipeline failed to open distally and moved during deployment.The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the cavernous segment of the right ica.The max diameter was 5.31mm, and the neck diameter was 12mm.The patient's vessel tortuosity was moderate.The landing zone was 4.17mm distal and 4.89mm proximal. dual antiplatelet treatment was administered, and the pru level was said to be 120.It was reported that while landing the pipeline near the ophthalmic region of the ica, the aneurysm was incorporated into the dysplastic cavernous region which had an acute turn.The device started to open at the most distal portion off the ptfe sleeves, but did not want to open past that and began to fish mouth.It then dropped down into the dysplasia/fusiform aneurysm.They were able to resheath the device and reposition the phenom 27 in a second attempt to deploy in the correct area.The device and the system dropped again.This time while attempting to resheath the pipeline the distal end bent and appeared to be crimped at the tines.They then fully recaptured the device and removed the microcatheter the pipeline inside.Upon back table inspection it was agreed the device was now damaged.Replacement devices were able to successfully deploy with no issues. the patient did not experience any injury or complications.Final angiographic results were said to be great with the replacement pipeline.The pipeline had not been positioned in a bend, and more than 50% had been deployed when it failed to open.The pipeline had been resheathed 2 or less times, and no additional steps were taken to open the device.It was noted that there was moderate friction/difficulty during delivery or positioning.The p ipeline had jumped and missed the landing zone during deployment.The pipeline was at least 3mm past the aneurysm neck on each side.No side branches were covered by the pipeline, and the tip of the catheter was not moved during deployment.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a ballist sheath, phenom plus guide catheter, phenom 27 microcatheter, and aristotle 24 guidewire.

Manufacturer Narrative

H3: the pipeline flex and the phenom 27 catheter were returned for analysis.The pushwire was protruding from the hub and the braid was partially deployed from catheter tip.In addition, sleeves and tip coil were deployed from catheter distal tip.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.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.No bend was observed on the pushwire.The distal and proximal ends of the pipeline flex were found fully opened and moderately damaged.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.No other anomalies were observed.For further examination, the pipeline flex was pushed out from the catheter without issues.The total and usable lengths of the catheter were measured to be within specifica tions.The catheter was flushed with water and water exited out from the distal tip.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, lumen and tip with no i ssues.Based on the analysis findings, the pipeline flex was not confirmed to have failure to open at the distal end and resistance.No resistance was observed during testing.In addition, the distal and proximal ends of the pipeline flex braid appeared fully opened and moderately frayed.However, the cause for damage could not determine.Possible cause includes patient tortuous anatomy.However, based on the analysis findings, the phenom 27 was not confirmed to have catheter resistance.The root cause could not be determined as no defects were found with the returned catheter.It's possible that the moderate vessel tortuosity may have contributed to the catheter resistance.There was no non-conformance to specifications identified that led to the resistance 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 there was not resistance with the catheter.It was believed that the damage happened when the devices dropped into the curve and maybe prolapsed on itself.There was no damage to the pipeline pushwire or catheter, the damage seemed to just be to the pipeline.

• 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: 15237394
• MDR Text Key: 305337823
• Report Number: 2029214-2022-01386
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: 00763000284725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B180021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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: 19 YR
• Patient Sex: Female
• Patient Weight: 38 KG