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

Model Number	IMP-FX-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lhrs for lot fr24072501u was reviewed and there were no unresolved issues or anomalies identified related to the reported device malfunction.At final qc, the compressed foam diameter underwent 100% inspection, and non non-conformities were identified.Review of the associated lot release test report, tr1825, also uncovered no findings that could be definitively or possibly be linked to this complaint.All samples used in simulated use testing passed the one-minute working time specification with 95/90 confidence and reliability.All samples underwent dimensional verification for crimped foam od passed the specification with 95/90 confident and reliability.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 devices migrated due to the aggressive flushing of the sheath.
Event or Problem Description
While treating a patient during a carto case, an imp-fx-12 plug (lot #fr24072501u) was lodged in a sub-segmental branch of the left lung (lingular branch).Dr.(b)(6), md at (b)(6) performed a tips procedure.Access was via the left internal jugular and the femoral since the right internal jugular was occluded.Access was also difficult due to a defibrillator in place.The shunt was created with a gore viatorr tips graft where there is a portion with open stent struts and most of its length is ptfe covered.The goal of the carto was to embolize a large vericele to prevent its rupture.Amplatzer plugs were to be used to act as a backstop in a large section of the vessel (measuring about 18 mm in diameter).In total 2 imp-10 (lot #f23090701e) and 15 imp-fx-12 (10 lot #fr24080601u and 5 lot #fr24072501u) were implanted.After the last fx plug was delivered, the ir resident aggressively flushed the sheath which forced the plug retrograde into the hepatic vein, then celiac, ivc, through the right heart and into the lung where it lodged in a sub-segmental branch of the left lung (lingular branch).Dr.Procell determined that the plug had landed very distal and the infarct was small and would a clinically insignificant portion of the lung.Furthermore, dr.Procell determined that the risk of crossing the right heart and attempting to snare or aspirate (entire inari toolkit was available) was greater than the risk of leaving it alone; therefore, he left the plug there.On the following day, dr.(b)(6) reported that the patient was doing well and experienced no chest pain whatsoever.

• 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: 21649206
• Report Number: 3013353964-2025-00002
• Device Sequence Number: 21151309
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/14/2025

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: FR24072501U
• 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: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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