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

Model Number	IMP-FX-12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with an abdominal aortic aneurysm was previously treated with an endovascular graft (not manufactured by smm).Later the patient presented with a type 2 endoleak where the aneurysm had also grown 1 cm and as a result required reintervention where the impede-fx (smm) device was used.The physician gained access to the aneurysm/endoleak cavern via perigraft through the right limb and shot contrast into the sac confirming appropriate sheath placement.The physician then advanced the sheath higher into the sac.Mid-procedure, fluoroscopic imaging was performed, and it was found that contrast, as well 6 impede-fx devices and extravasation was observed unintentionally outside the aneurysm.The physician proceeded with the procedure and delivered additional impede-fx devices as planned pre-procedurally.A thrombin slurry (not manufactured by smm) was also injected into the target site to complete the procedure.The final imaging confirmed that no new contrast was leaking outside of the aorta.It is possible that the sheath advancement higher into the sac pushed the guidewire through the aneurysm wall which led to the devices being unintentionally deployed outside of the target site.
Additional Manufacturer Narrative
The manufacturing documentation for the lot associated with this incident (f23102701u) was reviewed and no unresolved issues or anomalies were identified that might be related to the events described in this complaint.A benchtop investigation was not performed since the devices were implanted in the patient and could not be returned to shape memory medical.Based on shape memory medical's review of received information, the root cause for the unintended delivery of plugs outside of the aorta is possibly due to the procedure where it was reported that the guidewire placement was moved prior to device delivery.It is possible that the guidewire was unintentionally pushed through the aneurysm which would allow devices and contrast to be inadvertently delivered outside of the aneurysm.However, without additional information, a root cause cannot be definitively confirmed.There was no device malfunction reported and the guidewire used during the procedure is not manufactured by smm.The procedure was otherwise completed without incident and no serious adverse event to the patient was reported.A supplemental report will be filed should additional information be received from the complainant.Shape memory medical complaint reference number: (b)(4).

• 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: 19470445
• Report Number: 3013353964-2024-00006
• Device Sequence Number: 17985984
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/28/2024

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 Lot Number: F23102701U
• 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: 05/09/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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