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

Model Number PED2-500-35

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

Patient Problems Fistula (1862); Intracranial Hemorrhage (1891)

Event Date 05/27/2021

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 distal segment of the pipeline failed to open.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the left internal carotid-cavernous artery.The max diameter was 23mm, and the neck diameter was 13mm.The patient's vessel tortuosity was severe.The landing zone was 5mm distal and 3.5mm proximal.The access vessel was about 4-5mm in diameter.Dual antiplatelet treatment was administered.It was reported that the pipeline was planned to be implanted in the vicinity of the internal carotid-ophthalmic segment.The distal tip of the pipeline deployed poorly.An attempt was made to resolve the poor deployment by performing resheathing with the phenom 27 microcatheter several times, changing the deployment position, and delivering guide catheter slightly distally.Since it could not be resolved, it was decided to replace the device and the pipeline was collected with the microcatheter.The distal part of the pipeline was located in a bend when it failed to open, and less than 50% had been deployed at the time.The device had been resheathed 3 or more times, and no additional devices or other steps were taken to deploy the device.The pipeline had experienced resistance in the distal part of the phenom 27 shaft.The pipeline and phenom catheter were removed.After that, when confirmatory contrast was performed, a phenom17 was induced transarterically because a carotid-cavernous fistula (ccf) came to the distal side of the aneury sm.Coil embolization was performed from the venous side, but bleeding did not stop so high flow bypass was performed.It was changed to a surgical procedure.Since the patient was under general anesthesia, the patient's consciousness could not be confirmed, but t here was no regurgitation into the skull by ct imaging and there seemed to be no changes in vital signs.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter, navien 5f guide catheter, and chikai 14 guidewire.

Manufacturer Narrative

G3: pma/510(k) corrected.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

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 device was not able to be implanted due to the ccf.It was unclear if the ccf was caused by the product or procedure, and it was unknown if the patient experienced symptoms.

Manufacturer Narrative

H3.Product analysis: the pipeline flex shield was returned stuck within the phenom 27 catheter and outer carton; inside of a sealed bio-hazard bag and a shipping box.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 end of the pipeline flex shield braid appeared to be not opened due to damaged braid.The proximal end of the pipeline flex shield was found fully opened and frayed.Bends were found at 17.0cm to 42.5cm 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 pipeline flex shield was pushed out from the catheter lumen with difficulty.The catheter was flushed with water and water exited out from the distal tip.No other anomalies were observed.Based on the returned devices, the pipeline flex shield was confirmed to have ¿resistance during delivery¿ and "failure to open at the distal end" issues as the returned pipeline flex shield was found stuck inside the phenom catheter.In addition, the distal end of the pipeline flex shield braid was not opened due to damaged braid.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex shield braid (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 phenom catheter against the resistance.However, the root cause could not be determined.It is possible that the severe vessel tortuosity may have contributed to the resistance and failure to open issues.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.There was no non-conformance to specifications identified that led to the resistance issue.Per our instructions for use (ifu), the user should: ¿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 has successfully expanded, deploy the remainder of the 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.Discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.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: 11940127
• MDR Text Key: 254639097
• Report Number: 2029214-2021-00671
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B188100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR