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

Model Number	IMP-FX-12
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint notification was received 7/23/25 with no details about this incident other than the description "infected aaa with shape memory plugs".Inquiries for details have been made on approximately 8 occasions from 7/23/25 through 9/25/25 with no further details received about this complaint.Another request for feedback has been sent out to complainant.10/22/25 - received a video of the doctor conducting a presentation based on this case.What is known from the presentation is: the evar was performed on (b)(6) 2024 using 30 plugs.Summer of 2025 - travels to taiwan- has some bad chicken and admitted for sever gastroenteritis and septic shock and diagnosed with salmonella bacteremia patient was stabilized and sent back to the u.S.And admitted directly to the hospital and showed salmonella bacteremia on the scan and treated with antibiotics for 3 weeks and 2 weeks house arrest.After 2 weeks the pelvis was still inflamed.Right axillary-bifemoral bypass with ligation of right distal external iliac artery was performed on (b)(6) 2025.Dr.Commented: "these plugs can become infected, i suppose, not sure if that's the culprit here but the plugs were very incorporated into the wall of the aorta.All intraoperative cultures were also negative.Not sure if it was because of 3 weeks on antibiotics or 2 weeks under house arrest but pretty sterile contents of the sac".
Event or Problem Description
Infected aaa with shape memory plugs.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: IMPEDE-FX
• 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: 23418151
• Report Number: 3013353964-2025-00012
• Device Sequence Number: 18399201
• 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: 2024
• Device Explanted 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): 10/29/2025

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: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Other
• Patient Sex: Unknown