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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline stent tip failed to open.The patient was undergoing surgery for treatment of a saccular, ruptured internal carotid artery c7 segment aneurysm.It had a max diameter of 2.5 mm and a 2 mm neck diameter.The landing zone was 1.79 mm distally and 5.39 mm proximally.The access vessel was the femoral arterywith a diameter of 8 mm.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered at an unknown platelet reactivity units (pru) level.It was reported that the surgeon suspected the aneurysm to be a blister-like, and planned to perform treatment using coil embolization assisted by a dense-mesh stent.The surgeon utilized a non-medtronic stent microcatheter to deploy the stent.After positioning the stent microcatheter in the m2 segment and the echelon-14 microcatheter in place, it was delivered and embolization of the aneurysm was performed.A pipeline (ped 4.75-16) stent was then delivered to the straight segment of m1.When withdrawing the microcatheter, the stent's tip was exposed approximately 5 mm; upon attempting to advance the delivery rod¿moving it forward by about 15 mm¿the stent tip failed to open and remained in a rod-like configuration.The stent was retrieved to continue exposing the tip by 5 mm, the delivery rod of the stent moved forward, but the stent tip remained in a rod-like configuration.The entire assembly was then retracted back into the internal carotid artery; as the stent tip remained unopened, it was fully retrieved.The stent tip was repositioned to the "rivet point", and another attempt at deployment was made; however, the stent tip again failed to open, retaining its rod-like form, while the proximal portion of the stent did open.To ensure surgery safety, the stent was replaced with a new one, and the procedure continued.There were no patient symptoms or complications associated with this event.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Ancillary devices include a johnson & johnson long sheath, a stryker xt-27 stent microcatheter, a phenom plus guide catheter, a echelon 14 microcatheter, a stryker guidewire, and ev3 coils.
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.

• 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: 24885254
• Report Number: 2029214-2026-00677
• Device Sequence Number: 9851936
• Product Code: OUT
• UDI-Device Identifier: 00763000449452
• UDI-Public: (01)00763000449452(17)290115(10)D089171
• 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): 06/15/2026

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: D089171
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 05/18/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/15/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 55 KG