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

Model Number	IMP-FX-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This was a commercial case in which the impede-fx 12mm (imp-fx-12) was being used to treat a type 2 endoleak on a patient that had undergone an evar procedure.A 6fr mpa1x125cm cordis vista brite tip guiding catheter was used to deploy three (3) imp-fx-12 devices.Access to the sac was obtained using laser fenestration via the right limb.The first two plugs deployed without incident.The third plug, which was deployed no differently with the guide catheter in the same position, exited the sac and traveled up the cava to the pulmonary artery.A pulmonologist came into the room and assessed the plug's location and determined there was no clinical sequelae and therefore left the plug to stay.The patient was discharged the following day with no lung issues.Dr.(b)(6), the treating physician, believes a pre-existing aortocaval fistula was uncovered when thrombus was disturbed, allowing the plug to escape.A benchtop investigation was not performed since the patient remained stable and the migration did not lead to any sequelae; therefore, the device remains in the patient.Pre-procedure images are available for this case and were reviewed by (b)(6) (smm sales virtually present at case) and (b)(6) (smm r&d).However, this patient had been treated for the endoleak previously and used a combination of coils and glue making it difficult to view portions of the aorta due to artifacts from these devices.Therefore, a fistula existing prior to the procedure could not be definitively confirmed.Post-procedure images are not available for review.A review of the lot history record and associated documentation for the reported device lot was performed.There were no anomalies, deviations, or unresolved issues identified that could be linked to the reported migration event.All inspection and release criteria were met at the time of manufacturing, and the device met all established product specifications prior to distribution.The impede-fx instructions for use, ifu1354 rev b indicates that "the impede-fx embolization plug is indicated for use with the impede embolization plug to obstruct or reduce the rate of blood flow in the peripheral vasculature." in this case, the device was used to treat a type 2 endoleak following endovascular aneurysm repair (evar), which is outside the labeled indication as abdominal aortic aneurysms are not part of the peripheral vasculature.Additionally, though the impede-fx is indicated for use with the impede embolization plug, no impede embolization plugs were used in this case.The impede-fx instructions for use, ifu1354 rev b indicates that "physicians should exercise clinical judgment when using the impede-fx embolization plug in anatomy that may lead to unintended device placement and/or movement (i.E.High flow vasculature, large luminal vessel diameter)." shape memory medical complaint reference number: (b)(4).
Event or Problem Description
An evar with a type ii endoleak was being treated.A 6fr mpa1x125cm cordis vista brite tip guiding catheter was used to deploy three (3) imp-fx-12 devices.Access to the sac was obtained using laser fenestration via the right limb.The first two plugs deployed without incident.The third plug, which was deployed no differently with the guide catheter in the same position, exited the sac and traveled up the cava to the pulmonary artery.A pulmonologist came into the room and assessed the plug's location and determined there was no clinical sequelae and therefore left the plug to stay.The patient was discharged the next day with no lung issues.The following individuals were present at the case: (b)(6), smm (attending virtually with video & audio).(b)(6) (attending in-person).

• 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; santa clara CA 95131
• Manufacturer (Section G): SHAPE MEMORY MEDICAL, INC.; 1321 ridder park drive; suite 10; santa clara CA 95131
• Manufacturer Contact: meghan reu ; 1321 ridder park drive; suite 10; santa clara, CA 95131
• MDR Report Key: 24491851
• Report Number: 3013353964-2026-00003
• Device Sequence Number: 10666411
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: IMP-FX-12
• Device Catalogue Number: IMP-FX-12
• Device Lot Number: FR25052801U
• 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: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR MPA1X125CM CORDIS VISTA BRITE TIP GUIDING CATH.; ENDOVASCULAR GRAFT (MEDTRONIC ENDURANT).
• Patient Sex: Unknown