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

Model Number	PED2-475-16
Medical Device Problem Codes	Retraction Problem (1536); Device Damaged Prior to Use (2284); Packaging Problem (3007); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular flow diversion procedure using a pipeline embolization device, several issues were encountered.Initially, the device could not be delivered because the protective sheath was in a closed state.This was resolved by cutting open the sheath with surgical scissors.During the implantation process, the stent's position required adjustment, and an attempt was made to retrieve and redeploy the stent.However, the stent could not be retrieved after deployment.The angiographic result post procedure showed contrast agent retention in the aneurysm located in the cavernous sinus segment, which was unruptured and saccular with a maximum diameter of 6 millimeters and a neck diameter of 4 millimeters.The distal landing zone artery size was 3.9 millimeters, and the proximal was 4.7 millimeters, with moderate vessel tortuosity.Dual antiplatelet treatment was administered, and the platelet reactivity unit level met the standard.The customer alleged serious quality problems with the stent and requested it be reported.The device was replaced by another product.Ancillary devices include: 8f cordis guide catheter, marksman microcatheter, synchro 14 guidewire.
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-marksman (unknown); implant date n/a; explant date n/a.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
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 was received reporting that a nearby ped model product was subsequently replaced and the surgery was completed.The cause of the sheath being in a closed state was the professor confirmed that when it was opened, it was immediately discovered that sheath was in a closed state, and then it was opened with surgical scissors.The cause of the resistance was unknown, the professor repeatedly stressed that the stent could not be retrieved and therefore could not be repositioned for deployment.There was no damage or evidence of tampering to device packaging.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield embolization device was returned for analysis within a shipping box; within a plastic bio-pouch; within an opened pipeline flex shield inner pouch; and within a dispenser coil.The marksman catheter used in this event was not returned.Therefore, any contributing factors could not be assessed.Damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found fully opened and damaged.No other anomalies were observed.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: 21178518
• Report Number: 2029214-2025-00154
• Device Sequence Number: 20983216
• Product Code: OUT
• UDI-Device Identifier: 00763000284619
• UDI-Public: 00763000284619
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: B772108
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 01/23/2025; 03/29/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/11/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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 Sex: Female