MAUDE Adverse Event Report: MICROVENTION INC. STENT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FREDX4520-PMA
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fredx was chosen for treatment of a cavernous right ica aneurysm.During the pre-procedural plan, representative indicated that a longer device than the physician selected would be appropriate.Physician selected a shorter device.During deployment, the device was re-sheathed twice to position the distal end more proximal in the ica to avoid a potential 'ledge' effect with deployment on a curve.When reaching the end of the stent deployment, it was observed that the stent was not fully opened.While attempting to recapture the stent, the stent was partially deployed with 2 proximal tines deployed and 2 tines still inside of the bumpers with the microcatheter over the proximal end of the stent.During that time the physician then advanced the microcatheter, causing the stent to ¿stack¿ over the aneurysm neck.It was noted that the proximal end of the stent would be difficult to open following that maneuver.The decision was then made to use a snare to recapture the fredx device and remove it.There was no reported patient injury and the patient was later discharged.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation.However, it has not yet been returned.Medical imaging was provided and it is currently being reviewed.The investigation results will be provided in a supplemental report.
Additional Manufacturer Narrative
Additional information was received via email.B5 was updated to integrate the new information: case was completed with no treatment of the aneurysm, pt status is unknown, and the stent was completed detached during the case, which is why the snare was used to recapture it.H6 - impact code updated.
Event or Problem Description
It was reported that a fredx was chosen for treatment of a cavernous right ica aneurysm.During the pre-procedural plan, representative indicated that a longer device than the physician selected would be appropriate.Physician selected a shorter device.During deployment, the device was re-sheathed twice to position the distal end more proximal in the ica to avoid a potential 'ledge' effect with deployment on a curve.When reaching the end of the stent deployment, it was observed that the stent was not fully opened.While attempting to recapture the stent, the stent was partially deployed with 2 proximal tines deployed and 2 tines still inside of the bumpers with the microcatheter over the proximal end of the stent.During that time the physician then advanced the microcatheter, causing the stent to ¿stack¿ over the aneurysm neck.It was noted that the proximal end of the stent would be difficult to open following that maneuver.The stent had been completely detached at some point during deployment, so the decision was then made to use a snare to recapture the fredx device and remove it.The case was ended with no treatment of the aneurysm.There was no reported patient injury and the patient was later discharged.The status of the patient is unknown.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The reported complaint is non-verifiable.A single 3d reconstruction image was provided for review.It shows a right ica dsa, oblique projection, with a medium-sized wide-necked cavernous aneurysm just distal to the posterior genu of the cavernous ica.The provided image does not explain why the problems described in the clinical event were encountered.The investigation of the returned stent system found the stent returned fully deployed and deformed with the inner stent collapsed at the proximal section; however, the stent fully opened after being cleaned of residual blood and tissue.Replication testing was performed, and the stent was able to successfully advance through an in-house microcatheter and fully open upon deployment.The investigation could not determine if the deformity occurred prior to or after the reported snare usage; therefore, this complaint is considered non-verifiable.The investigation did not find any damage or other anomaly that would have caused or contributed to the reported expansion issue.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that a fredx was chosen for treatment of a cavernous right ica aneurysm.During the pre-procedural plan, representative indicated that a longer device than the physician selected would be appropriate.Physician selected a shorter device.During deployment, the device was re-sheathed twice to position the distal end more proximal in the ica to avoid a potential 'ledge' effect with deployment on a curve.When reaching the end of the stent deployment, it was observed that the stent was not fully opened.While attempting to recapture the stent, the stent was partially deployed with 2 proximal tines deployed and 2 tines still inside of the bumpers with the microcatheter over the proximal end of the stent.During that time the physician then advanced the microcatheter, causing the stent to ¿stack¿ over the aneurysm neck.It was noted that the proximal end of the stent would be difficult to open following that maneuver.The stent had been completely detached at some point during deployment, so the decision was then made to use a snare to recapture the fredx device and remove it.The case was ended with no treatment of the aneurysm.There was no reported patient injury and the patient was later discharged.The status of the patient is unknown.

• Brand Name: STENT
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21165385
• Report Number: 2032493-2025-00067
• Device Sequence Number: 17206475
• Product Code: OUT
• UDI-Device Identifier: 00842429114407
• UDI-Public: 00842429114407
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FREDX4520-PMA
• Device Catalogue Number: FREDX4520
• Device Lot Number: 0000681077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/10/2025; 03/28/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/06/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female