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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a pelvic congestion syndrom (pcs) case, six imp-fx-12 plugs (lot fr25061301u) were implanted into the gonadal vein and 2 of the 6 plugs migrated into the right pulmonary artery.The patient remained in stable condition and no serious clinical adverse event to the patient was reported.Two possible theories were provided by the complainant: theory 1: the devices migrated distally first and later moved toward the pulmonary artery.The 6f long sheath was not removed until the start of the nutcracker treatment, so the likelihood of the devices bypassing it and moving upward seems low.Theory 2: the migration was immediately proximal.The contrast injection may have created enough turbulence or retrograde flow to carry the devices into the systemic circulation.Since vessel diameter increases as it nears the heart, this seems more plausible.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.On 01/26/2026 communication through video conference with christy yen (getz) was conducted with tom lewis (smm sales) and maryanne koller (smm marketing) to discuss the case and possible root cause(s) for the migration.Since all parties in attendance of the video conference were not present during the case, all discussions were gathered from the information that was initially reported to christy yen from the hospital and 3 getz representatives present at the case.It was discussed that the physician had performed about 3-4 pcs cases prior to this case, no images were provided, and only imp-fx-12 plugs were used during this case.It was also confirmed that the migration occurred prior to placing the cook coils.Christy also confirmed that she does not think this incident is related to the device.A likely root cause of the plug migration could be due to high flow vasculature.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.On 01/28/2026, review of impede-fx instructions for use, ifu1352, ifu1182, and ifu1398 were reviewed for relevant information.Ifu review: · "physicians should exercise clinical judgement when using the impede-fx embolization plug in anatomy that may led to unintended device placement and/or movement (i.E.High flow vasculature, large luminal vessel diameter)." a supplemental report will be filed should additional information be received from the complainant.Shape memory medical complaint reference number: (b)(4).
Event or Problem Description
During a pelvic congestion syndrom (pcs) case, six imp-fx-12 plugs were implanted into the gonadal vein.After the final two were placed, the result was confirmed with contrast and three cook coils were placed at the proximal end.It was then realized that the last two imp-fx-12 were missing from the target site.Initially, it was thought that they had migrated distally (deeper into the pelvic floor).The physician proceeded to treat the nutcracker and may-thurner syndromes, however, upon a final check, it was discovered the two missing imp-fx-12 in the right pulmonary artery.The patient remained stable, so the devices were left in situ.

• 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
• MDR Report Key: 24408143
• Report Number: 3013353964-2026-00002
• Device Sequence Number: 12801668
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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
• Device Model Number: IMP-FX-12
• Device Catalogue Number: IMP-FX-12
• Device Lot Number: FR25061301U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown