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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was treated for type ii endoleak on 09/23/2024 using 70 impede-fx devices (imp-fx-12) after being diagnosed with type ii endoleak and expanding aorta.The procedure was completed without any reported incidents.During the 30 day follow up scan on 10/24/2024, it was noticed that some of the devices appear to be located in or on the aortic wall and between the thrombus and the aortic wall.The patient status was stable and no serious adverse event was reported.No further re-intervention was performed.The physician scheduled the patient for follow up appointments to continue to monitor.Lot numbers of imp-fx-12 device used: lot#fr24041101u, qty: 44, exp date: 2027-08-06, manufacturing date: 05/06/2024; lot#fr24062810u qty: 10, exp date: 2027-10-15, manufacturing date: 07/15/2024; lot#fr24040501u qty: 11, exp date: 2027-07-23 manufacturing date: 04/23/2024; lot#fr24062501u qty: 5, exp date: 2027-09-28 manufacturing date: 06/28/2024.
Additional Manufacturer Narrative
Patient was treated for type ii endoleak after being diagnosed with type ii endoleak and expanding aorta.70 imp-fx-12 devices were implanted in the patient on (b)(6) 2024 and no incidents were reported.During the 30 day follow up scan on (b)(6) 2024, the physician noticed that some of the devices appear to be on or in the aortic wall and between the thrombus and the aortic wall and smm was notified about this complaint.No other serious adverse events to patient were reported and the physician scheduled follow up appointments to continue monitoring the patient.Case images were received for smm's review.Upon review of the intra-op images and follow up ct scans, it is possible that the devices were originally implanted within the aortic wall due to the access catheter being positioned within the wall and thereby was not spread out in the sac as intended.In this case, the unexpected positioning observed at the 30 day follow up would not be a result of migration or movement of the plug but of access or malpositioning during the original procedure.However, without additional information, a root cause could not be definitively confirmed in this case.The 30 day follow up scans confirmed that there were no plugs outside the aortic sac.Additionally, there was no malfunction of the device reported during the procedure.Furthermore, manufacturing documentation of imp-fx-12 devices used in this procedure were reviewed and no findings were made that could be attributed to this incident.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 dr.; suite 10; san jose CA 95131
• Manufacturer Contact: meghan reu ; 1321 ridder park dr.; suite 10; san jose, CA 95131 ; 4086495175
• MDR Report Key: 20799097
• Report Number: 3013353964-2024-00013
• Device Sequence Number: 6895178
• 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
• 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): 11/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: IMP-FX-12
• Device Lot Number: LISTED IN SECTION 5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/27/2024
• 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
• Patient Sex: Unknown