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

Model Number	IMP-FX-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Hemorrhagic Stroke (4417)
Date of Event	09/25/2025
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2025, a patient was being treated at (b)(6) center for an abdominal aortic aneurysm (aaa) endoleak in conjunction with bilateral iliac branches to address distal seal in the original medtronic endurant stent graft (mdt endurant).The aaa embolization occurred first procedurally where dr.(b)(6) implanted 50 imp-fx-12 plugs.The right then left iliac branches treatment using gore devices followed afterwards.At the end of the procedure embolization was complete, and the patient was in stable condition.The patient remained in the hospital per normal procedure, however overnight (post-operation) the patient experienced intracerebral hemorrhage (ich) and expired.It was reported by shape memory medical (smm) representatives, (b)(6), who were notified and communicated with dr.(b)(6) of the adverse event, that the ich was unrelated to the aaa embolization/smm devices.Dr.(b)(6) stated that, "he [the patient] had balloon angioplasty of his aortic valve two days ago so probably hemorrhagic transformation.".
Additional Manufacturer Narrative
Based on the information received, the patient had undergone procedure on (b)(6) 2025 of an abdominal aortic aneurysm (aaa) endoleak using imp-fx-12 devices.50 devices were deployed to the target site without any incident.At the end of the procedure, embolization was complete and the patient was in stable condition.The patient had expired overnight on (b)(6) 2025 experiencing intracerebral hemorrhage (ich).It was reported by smm representatives, (b)(6), that dr.(b)(6) stated, "he [the patient] had balloon angioplasty of his aortic valve two days ago so probably hemorrhagic transformation" that caused the ich.No smm devices were used in the prior balloon angioplasty procedure that occurred before on (b)(6) 2025.No imaging or additional evaluation was performed at the time of the event as well as no autopsy or further examinations were performed to confirm the cause of death.Additionally, review of the lot history record and accompanying lot release report identified no quality issues related to the device performance or indicative of a device malfunction which could be attributable to the event.Therefore, without additional information the specific root cause associated with the event cannot be definitively determined.A supplemental report will be filed should additional information be received.(b)(4).

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL INC.; 1321 ridder park drive; suite 10; san jose CA 95131
• Manufacturer (Section G): SHAPE MEMORY MEDICAL INC.; 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: 23344095
• Report Number: 3013353964-2025-00011
• Device Sequence Number: 9544747
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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 Lot Number: FR25022801U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: Death
• Patient Sex: Male