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	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing documentation for the lot associated with this device/incident could not be reviewed since the lot number was not provided.A benchtop investigation was not performed since the device was implanted in the patient and could not be returned to shape memory medical inc.Based on shape memory medical's review of received information, it was reported by the smm employee familiar with the case that the 5f sheath used to deliver the imp-fx-12 plug may have not been in the target location (sma dissection).However, without additional information, a root cause cannot be definitively confirmed.Other than the suspected migration, there was no device malfunction reported and the 5f sheath used during the procedure is not manufactured by shape memory medical.Additionally, the impede-fx-us instructions for use, ifu1354-01 rev a, states that "physicians should exercise clinical judgement 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)." the imp-fx-12 plug remains in a false lumen of the infrarenal aorta.No serious clinical adverse event to the patient was reported.A supplemental report will be filed should additional information be received from the complainant.Note: the impede-fx-us ifu1354-01 rev a also states 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;" this means the impede-fx device is indicated to be used with the impede device (510k number: k181051) to mitigate migration risks.The patient was implanted with 2 imp-fx-12 devices and a stent.Shape memory medical complaint reference number: (b)(4).
Event or Problem Description
On (b)(6) 2025 at (b)(6) medical center in (b)(6) usa, during treatment of a tevar and sma stent/embolization an imp-fx-12 plug migrated and was not delivered at the target site.The imp-fx-12 plug was planned for embolization of the sma dissection after a self-expanding stent was deployed in the sma true lumen.During deployment of the imp-fx-12 plug, the plug traveled into the infrarenal aorta.It is unknown if the 5f sheath used to deliver was in the right location.Dr.(b)(6) decided to leave the plug in the infrarenal aorta and continue with the procedure as a 2nd imp-fx-12 plug was deployed and implanted at the target location - the sma dissection.The physician then stopped the procedure after the fluoroscopy stopped working.On (b)(6) 2025, it was initially reported by the shape memory medical (smm) employee familiar with the case that the 1st imp-fx-12 plug traveled into the infrarenal aorta.On (b)(6) 2025, from a follow-up email regarding the case, it was reported by another smm employee familiar with the case that the 1st imp-fx-12 traveled to the false lumen of the aorta and the physician did not find it a concern to leave the imp-fx-12 plug in this location; the imp-fx-12 plug remains in a false lumen of the infrarenal aorta of the patient.No serious clinical event occurred to the patient and the patient is stable.

• 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
• MDR Report Key: 22294159
• Report Number: 3013353964-2025-00008
• Device Sequence Number: 8467067
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/19/2025
• 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
• Patient Sex: Unknown