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

Model Number	PED3-021-250-16
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report of two pipeline vantage devices that failed to open.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm located in the basilar artery with a max diameter of 4.3mm and a 5.3mm neck diameter.The landing zone (artery size) was 1.3mm distal and 1.8mm proximal.It was noted the patient's vessel tortuosity was minimal.Dapt (dual antiplatelet treatment) was administered with an unknown platelet reactivity units (pru) level.The angiographic result post procedure was none.There are images available for review.It was reported that during flow-diverting stent implantation for an aneurysm, the aneurysm was a fusiform aneurysm located in the p2 segment.The intermediate catheter was in place, and the microcatheter was positioned appropriately.A 250-14 stent was selected.After delivering the stent to the target position, the tip end of the stent failed to open properly.Despite continued deployment, the stent remained rod-shaped.It was retrieved and redeployed three times in an attempt to achieve opening, but it still failed to open.The microcatheter and stent were replaced and the replacements were advanced to the target position.A 250-16 stent was selected.After deployment, the stent still remained rod-shaped.The operator attempted twice repeatedly, but the stent failed to open.After two unsuccessful attempts to retrieve, the microcatheter and stent were removed.Another assisting stent was used instead for embolization, and the procedure continued.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The pipeline devices were not used for any indication that is not approved (off-label).The catheter was flushed as indicated in the ifu.Ancillary devices include a 6f115 ton-bridge medical guide catheter and a phenom 21 microcatheter.
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
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
Update b5 and h6 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.It was unable to be determined whether there was a device issue with the phenom microcatheters used.No causes or contributing factors for the failure of the pipeline (ped3 021 250 16) to open were identified.Neither the distal nor the middle segment of the pipeline could be deployed properly.The pipeline devices were not placed in a vessel bend at the time of the deployment failure.Additional attempts were made to open the device, including three retrieval attempts and maneuvers such as pushing and swaying the microcatheter; however, despite these efforts, the device could not be opened.

• Brand Name: PIPELINE VANTAGE WITH 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: 24800243
• Report Number: 2029214-2026-00614
• Device Sequence Number: 21502546
• Product Code: OUT
• UDI-Device Identifier: 00847536036246
• UDI-Public: (01)00847536036246(17)280918(10)D066372
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2026

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: PED3-021-250-16
• Device Catalogue Number: PED3-021-250-16
• Device Lot Number: D066372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 04/08/2026; 05/07/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/05/2026; 06/04/2026
• Date Device Manufactured: 09/19/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1246-2025
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female