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

Model Number	PED2-500-14
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during a pipeline deployment, the pipeline stent came off of the resheathing pad.Healthcare provider (hcp) prepped pipeline device per the instructions for use (ifu) and advanced into phenom 027.Phenom 027 was distal to the aneurysm and began deployment.During the deployment the stent came off the resheathing pad while still constrained by the phenom 027.Hcp was able to remove the stent and the microcatheter from the patient.A new pipeline device was prepped and deployed.The patient woke up and sent to pacu.No injury from the failed pipeline deployment.The pipeline was used for an approved indication.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured left cavernous carotid artery aneurysm with a max diameter of 10 mm and a 6 mm neck diameter.The landing zone was 4.33 mm distally, and 4.99 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level 70.Angiographic result post procedure was that the patient was treated with another pipeline device.Second device was deployed successfully and there was a good angiographic result post procedure.Ancillary devices include a the dude guide catheter, phenom 027 microcatheter, aristotle 024 guidewire.
Additional 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 or Problem Description
Additional information received reported that only one pipeline device could be advanced through the microcatheter at a time.There was difficulty during deployment.The distal end of the pipeline was not opening appropriately and the customer was trying to manipulate the device to open.The pipeline device was not deployed.The device was removed using the phenom 027 catheter.A second pipeline device was implanted after the device outlined in this complaint was removed from the patient.After the device separated from the resheathing pad the device had jumped.
Additional 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.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield was returned within the phenom 27 catheter, inner pouch, a sealed bio-hazard bag, and a shipping box.The pipeline flex shield braid appeared to be detached from the resheathing pad and stuck at the distal tip of the catheter.Damage location details: the distal and proximal dps restraints were intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The distal and proximal ends of the braid were fully opened and frayed.The pushwire was found to be bent at 16.0cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordioned at 3.5cm to 15.7cm from the distal tip.No other anomalies were observed.Testing/analysis: the pipeline flex shield was pushed out from the catheter lumen with difficulty.The catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was tested by running an in-house 0.026¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub without issues; however, resistance was observed at the damaged locations.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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Common Device Name: 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21356688
• Report Number: 2029214-2025-00366
• Device Sequence Number: 18106408
• Product Code: OUT
• UDI-Device Identifier: 00763000284695
• UDI-Public: 00763000284695
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: B796968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 03/21/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 85 KG