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

Model Number PED-475-30

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id fg15150-0615-1s (lot: 227084166); product type: ; implant date n/a; explant date n/a 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 encountered resistance in the phenom catheter and was found detached.The patient was undergoing implantation of blood flow diversion device for treatment of an amorphous, unruptured aneurysm in the left internal carotid artery ophthalmic artery segment with a max diameter of 15 mm and a 8 mm neck diameter.Landing zone: distal: 4.0 mm and proximal 4.6 mm.The accessed vessel was the femoral artery.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet treatment was administered.The pru level was 0.The angiographic result post procedure showed an aneurysm had a certain amount of contrast agent retention.It was reported that on february 24, 2024, during the interventional treatment of an aneurysm of the ophthalmic segment of the left internal carotid artery, the operator chose 4.75x30 pipeline for implantation.When pushing to the cavernous sinus segment, the pipeline could not be pushed and withdrawn, and then the microcatheter and pushing system were withdrawn from the body.The pipeline was still unable to be pushed and withdrawn during the extracorporeal operation, and it was found that the pipeline was detached and remained in the microcatheter.The surgeon replaced the 4.5x30 pipeline and xt27 catheter and successfully completed the operation without injury to the patient.It was reported the pipeline was stuck (locked up) in the catheter or resistance in the catheter occurred in the distal section.The catheter was flushed continuously with heparinized saline.The pipeline did not become stuck.The pushwire was damaged in the distal section.The pipeline implant was detached and the pushrod had no kinking.It was reported there was catheter resistance in the distal section.The pipeline was not used for an indication that is off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that the cause of the resistance was not determined.It was noted that the pipeline was withdrawn from the body and detached from the delivery system.No other finds were found.

Manufacturer Narrative

Product analysis of ped-475-30, lotno:b624348 ¿ as found condition: the pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box; within a plastic bio-pouch; within an opened pipeline flex and phenom 27 inner pouches; and within dispenser coils.The pipeline flex pusher was returned outside the phenom 27 catheter.¿ damage location details: no bent or kink was found with pushwire.However, the pushwire was found to be separated/broken proximal to the dps sleeves.The tip coil and dps sleeves were not returned for analysis and the reason was not provided.No damages were found with re-sheathing pad or with the proximal bumper.The hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal and proximal ends of the pipeline flex braid appeared to be fully opened and damaged.No flash or voids molded were observed in the hub.No damage was found with hub.No bent or kink was found with catheter body.The phenom 27 catheter tip and marker were examined; and no damages were found.However, dried blood was present within distal tip.No other anomalies were observed.¿ testing/analysis: the total and usable lengths of phenom 27 catheter were measured to be within specifications.The braid could not be pushed forward or removed.For further examination, the catheter was cut to remove the braid from the catheter lumen.The catheter was flushed with water and water exited out of 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 and tip with no issues.The broken end was sent out for sem (scanning electron microscopy) analysis.¿ conclusion: based on the analysis findings, the pipeline flex and phenom 27 catheter were confirmed to have resistance during delivery.The pipeline flex was found to be damaged.From the damages seen on the pipeline flex braid (fraying) and hypotube (stretching); it is likely high force used during the delivery.Additionally, the pushwire was found to be separated proximal to the dps sleeves.Per the sem result, the broken end failed via torsional overload.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex through the phenom 27 catheter against resistance.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PIPELINE FLEX
• 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: 18797450
• MDR Text Key: 337536929
• Report Number: 2029214-2024-00351
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: B624348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 09/12/2023
• 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
• Treatment: SEE H11...
• Patient Age: 72 YR
• Patient Sex: Female