MAUDE Adverse Event Report: SHAPE MEMORY MEDICAL IMPEDE-FX EMBOLIZATION PLUG; Device, Vascular, for Promoting Embolization

Model Number	IMP-FX-12
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, during treatment of a small (less than or equal to 2 centimeters, 5 milliliter) ascending aortic pseudoaneurysm at mgh (boston), an impede-fx-12 plug migrated.The case involved dr.(b)(6) (vs, primary), dr.(b)(6) (cvs), dr.(b)(6) (ic), and trainees.After femoral access and multiple arch aortograms, a 45-minute c-arm malfunction delayed progress.The sac was eventually accessed using a vert and vanschie 3 catheter, followed by a 7f tourguide and 5f x 110cm cook flexor sheath.Dr.(b)(6) advanced a 7fx90cm tourguide steerable tip guide catheter (overall length was 105 centimeters), but was unable to get into sac and settled for having the tip positioned 2 to 3 centimeters away (which reduced the amount of backup support provided to the plug delivery catheter/sheath).Two impede-fx-12 plugs were deployed successfully, but the third migrated into the aorta.The sheath with two undeployed plugs was removed.Imaging could not locate the migrated plug, but it was confirmed that it was not located in the head, neck, arms or torso, and that all radial and pedal pulses were palpable.A non-smm plug was placed at the sac entry and a ct scan later showed the migrated plug lodged in a small profunda branch, causing minimal ischemia and requiring no retrieval.The pseudoaneurysm was fully thrombosed.
Additional Manufacturer Narrative
On september 30, 2025 and october 6, 2025, the complaint investigator (b)(4) further discussed the details of the case with the smm representative who was present during the procedure (b)(6).It was clarified that the pseudoaneurysm off the ascending aorta was the target and was presumably fed by the aorta but also had outflow vessel(s).This means flow direction (at least initially) would have been away from the aorta.In addition, this was a small neck pseudoaneurysm with the entry lumen equaling 3 millimeters.The plan was to use a 7f tourguide sheath to deliver a 6f guide catheter or 5f sheath for plug delivery.Since the diameter of the tourguide was larger than the neck, migration would be impossible while the sheath was in place.Further, they were unable to canulate the pseudoaneurysm with the tourguide sheath due to challenging angles, and possibly the fact that they used femoral access instead of brachial access.So, the pseudoaneurysm neck was obstructed by the 5f sheath alone, which had an outer diameter of 2.4 millimeters.While this was marginally smaller than the 3 millimeter neck, it was still very unlikely that a plug could escape around the 5f sheath.The real problem was that without the sheath engaged in the ostium of the pseudoaneurysm, there was significantly less back-up support, and this is what allowed the tip of 5f sheath to stick out as the plugs were being advanced.Additionally, the impede-fx instructions for use, ifu1354 rev b indicates that "the impede-fx device may only be used in conjunction with the impede embolization plug to further enhance vessel occlusion or increase the length of occlusion within the target vessel." it also states 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).".

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: Device, Vascular, for Promoting Embolization
• 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
• MDR Report Key: 23313428
• Report Number: 3013353964-2025-00010
• Device Sequence Number: 4967174
• 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): 10/16/2025

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: F24011608U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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