MAUDE Adverse Event Report: SHAPE MEMORY MEDICAL IMPEDE-FX EMBOLIZATION PLUG; VASCULAR EMBOLIZATION DEVICE

Model Number	IMP-FX-12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, while treating a patient with a translumbar type ii endoleak, 3 to 5 imp-fx-12 devices were deployed outside of the aortic sac.The physician (dr.(b)(6)) reported no immediate concerns.Additional information regarding the complaint was requested from the smm personnel, (b)(6).(b)(6) confirmed that the plugs were left in place and no attempt to retrieve the plugs were considered.(b)(6) also stated that the physician seemed fully aware that the plugs were placed outside the aorta due to delivery catheter manipulation that resulted in the catheter penetrating the aortic wall.The status of the patient was confirmed to be stable, and the patient was discharged the same day.No follow-up letter was requested by the complainant.On (b)(6) 2025, dr.(b)(6) provided (b)(6) with additional pictures and information and stated that the aneurysm has grown 1 cm since the intervention involving imp-fx-12 was performed and she is unsure of her next steps with this patient.
Additional Manufacturer Narrative
On 05/22/2025, additional information from the smm representative was provided including 1.The procedure was an endoleak repair with direct access to the aorta.Most of the plugs were placed in the aa sac.It is likely that the first 3 to 5 plugs were deployed outside the sac but there is no way to confirm.The surgeons used various wires and catheters during the procedure.2.The images provided to the smm representative from dr.(b)(6) are post operative.As of 05/28/2025, additional information has been requested and a follow up report will be submitted onces a conclusion by smm is made.
Event or Problem Description
Note: this is a follow up report to the initial report filed under the same number on 05/14/2025.No prior information is repeated within this report.No additional information from the smm personnel present during the case and from the smm personnel aware of but not present during the case was provided to the complaint investigator.Based on the information received, the root cause of delivering the plugs outside of the aneursym may have been due to the procedure/user technique where it was reported that the delivery catheter penetrated the aneurysm wall.Deployment and/or migration to an unintended location is an anticipated risk that is captured in the impede-fx risk management documentation (ufmea1002 rev e).The risk can be critical, depending on the anatomical location of the migration and/or unintended placement.In this case, the plugs were deployed outside of the aneurysm and no patient harm was reported.No further reinterventions were made.
Additional Manufacturer Narrative
See updates to description of adverse event or product problem (b5).

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL; 1321 ridder park drive; suite 10; san jose CA 95131
• Manufacturer (Section G): SHAPE MEMORY MEDICAL; 1321 ridder park drive; suite 10; san jose CA 95131
• Manufacturer Contact: meghan reu ; 1321 ridder park drive; suite 10; san jose, CA 95131 ; 4086495175
• MDR Report Key: 22108098
• Report Number: 3013353964-2025-00005
• Device Sequence Number: 18200904
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: IMP-FX-12
• Device Catalogue Number: IMP-FX-12
• Device Lot Number: FR25031001U
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown