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

Model Number	IMP-FX-12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 04/02/2025, a review of lot history records and associated lot release test report for the device could not be reviewed since the lot number was not reported.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)." it is possible that the device migrated due to its placement in an unstable landing zone with turbulent flow from the type 1a leak.It was noted that the risk of the plug needing rescue was discussed with the physician prior to the case.
Event or Problem Description
On (b)(6) 2025 at (b)(6) center, dr.(b)(6), was treating a type 1 endoleak on a 72 hour previously implanted, physician modified (laser fenestrations) mdt endurant and successfully rescued an impede fx-12 with an ensnare.Dr.(b)(6) was using a 6fr tourguide steerable sheath torqued 180° with a 6fr mdt launcher jr4.0 guiding catheter to deliver plugs into a posterior portion of the aorta that had aneurysmal degeneration and lacked graft to vessel apposition, due partly to enfolding of the endograft.Two plugs were successfully deployed and the 3rd plug began kicking the guidecath back as he pushed with a 260cm bentsen wire.The plug exited the catheter at the very proximal edge of the stent graft then followed the catheter out of the posterior outpouching and into the aorta fixating into the suprarenal stent of the graft when dr.(b)(6) retracted the cath to reposition.Using the ensnare he dislodged the plug from the suprarenal stent while attempting to snare and it traveled down the aorta and settled at the sg's bifurcation just above the contralateral limb.Dr.(b)(6) was able to snare and completely recover the plug from the patient.The lot number of the plug is unknown.Dr.(b)(6) went on to successfully deploy an additional 10 plugs for a total of 12 implanted into the patient as well as 8 mdt endoanchors.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• 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 ; 4086495175
• MDR Report Key: 21767351
• Report Number: 3013353964-2025-00003
• Device Sequence Number: 15576045
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: UNKNOWN
• 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: 03/07/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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