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

Model Number	IMP-FX-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient had shape memory medical inc.'s imp-fx-12 devices implanted to embolize a type 2 endoleak post endovascular repair with an endograft (not manufactured by smm).Perigraft access along the right limb of the stent graft was used to obtain access to the endoleak.The devices were only placed in the middle-third of the target area as not all portions of the endoleak were reachable.Deployment of the plugs went as expected and the procedure was completed.On (b)(6) 2024, the patient appeared to have an infection on the anterior aspect of the aneurysm sac and was transferred to barnes-jewish hospital for further observation.It is assumed that the infection worsened as the patient was then transferred to another facility and underwent an open explant of the aortic stent graft and smm devices.After the patient underwent explantation of the aortic stent graft and imp-fx-12 devices sometime between (b)(6)2024 through (b)(6)2025, no additional clinical sequalae was reported.The patient was discharged and is in stable condition.
Additional Manufacturer Narrative
Based on the information received, the patient had a procedure on (b)(6)2024 where shape memory medical's (smm) imp-fx-12 devices were used to embolize a type 2 endoleak post endovascular repair with an endograft (not manufactured by smm).Perigraft access along the right limb of the stent graft was used to obtain access to the endoleak.Deployment of the plugs went as expected and the procedure was completed.On (b)(6) 2024, the patient appeared to have an infection on the anterior aspect of the aneurysm sac and was transferred to (b)(6) hospital for further observation.It is assumed that the infection worsened as the patient was then transferred to another facility and underwent an open explant of the aortic stent graft and smm devices.The explantation date provided, (b)(6) 2024, is only an assumption as it was reported by the operating physician, dr.(b)(6), to smm personnel on (b)(6)2025 that the patient had undergone the additional procedure at another facility, and therefore the exact date was unknown.Dr.(b)(6) assumed the infection was caused by the imp-fx-12 devices; however, no testing was conducted to confirm this.Otherwise, there were no other device malfunctions reported.After the patient underwent explantation of the aortic stent graft and imp-fx-12 devices sometime between (b)(6)2024 through (b)(6)2025, no additional clinical sequalae was reported.The patient was discharged and is in stable condition.A benchtop investigation was unable to occur because the imp-fx-12 devices were not returned to (b)(6) medical after explantation from the patient.Instead, smm made multiple attempts to obtain additional information from the operating physician, dr.(b)(6) and smm also performed a record review of all relevant manufacturing records.A review of the lot history records identified no quality issues or anomalies related to the device performance or indicative of a device malfunction which could be attributable to the reported incident.All devices were manufactured according to the approved process.All lots are subject to final lot release testing to confirm devices will perform as expected.Review of the associated lot release test reports also uncovered no findings that could be definitively or possibly be linked to this reported incident.All lots are subject to routine pyrogen testing to ensure they are non-pyrogenic.The lots which are the subject of this reported incident underwent routine pyrogen testing and results confirmed that pyrogen levels were within specification.Additionally, the device is provided to the user e-beam sterile per a validated process which is routinely monitored through dose audit testing to confirm the effectiveness of the sterilization process.Therefore the 2024 q3 dose audit reports were also reviewed as the associated lots were manufactured in q3, and all testing passed where the overall average bioburden was found to be within acceptable limits and no growth was observed during sterility testing, confirming the continued effectiveness of the sterilization dose.As there was no testing conducted to confirm the infection was caused by the plugs and an additional device was also used to treat the patient (endovascular graft), without additional information the specific root cause associated with the event cannot be definitively determined.Note: two lots were used during treatment and there is only space on the 3500a form to list expiration and manufacturing dates for one lot.Below is the complete information for both lots.Fr24071101u (imp-fx-12 devices, qty: unknown) manufacture date: 07/18/2024 expiration date: 10/18/2027.Fr24073003u (imp-fx-12 devices, qty: unknown) manufacture date: 08/16/2024 expiration date: 11/16/2027.Total devices implanted and explanted: 50.A supplemental report will be filed should additional information be received.Shape memory medical inc.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 ; 4086495175
• MDR Report Key: 21164329
• Report Number: 3013353964-2025-00001
• Device Sequence Number: 14516063
• 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: 2024
• Device Explanted Year: 2024
• 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): 01/15/2025

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 Lot Number: FR24071101U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown