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

Model Number	IMP-FX-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the lot history record and accompanying lot release report identified no quality issues related to the device performance.A benchtop investigation could not occur because the imp-fx-12 device remains implanted in the patient.Based on the information received thus far, no root cause can definitively be attributed to the device malfunction - failure to fully expand to 12 mm.The device was deployed as intended and the patient is in stable condition and was discharged on (b)(6) 2024 after the 2nd follow-up consultation.The surgeon will continue to observe the patient for approximately 2 months.A supplemental report will be filed should additional information be received from the complainant.Shape memory medical inc.Complaint reference number: (b)(4).
Event or Problem Description
On (b)(6) 2024 at (b)(6) hospital, a patient was undergoing a balloon-occluded retrograde transvenous obliteration (brto) procedure and an imp-fx-12 device was placed in the hepatic vein by an internal jugular vein approach.The vascular diameter was from 7 mm to 11 mm and the embolization at the 7mm point was expected and placed without problems.On (b)(6) 2024, the patient's condition was checked with a computed tomography (ct) scan which showed that the placed imp-fx-12 device did not expand to 12 mm and did not fit the vessel.There was space between the vessel and the imp-fx-12 device.No migrations and health damage to the patient were reported on (b)(6) 2024.Another follow-up with the patient was conducted on (b)(6) 2024 and it was found that the target area had not fully embolized.The patient was discharged with no health damage and in stable condition.The surgeon will continue to observe the patient for approximately 2 months.

• 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: 20780545
• Report Number: 3013353964-2024-00010
• Device Sequence Number: 5005664
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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 Expiration Date: 06/30/2026
• Device Model Number: IMP-FX-12
• Device Lot Number: F23032201U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown