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

Model Number	IMP-07
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Peripheral Edema (4578)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the initial procedure on (b)(6) 2025.The patient noted swelling and it was found at follow-up on (b)(6) 2026, the imp-07 device had migrated from the target location of the wrist to around the elbow area of the patient.Due to the migration, the imp-07 plug was occluding the main vessel which resulted in the swelling and the decision of the physician to perform the "cut-down" procedure and explant the device.No serious clinical adverse event to the patient was reported and the patient was discharged from the hospital and is stable.A benchtop investigation was not performed since the device was explanted from the patient and discarded at the hospital on (b)(6) 2025.The device could not be returned to (b)(6).Additionally, communication through video conference with (b)(6), a representative from (b)(6) - taiwan branch (smm taiwan distributor) was conducted with sales, (b)(6), and marketing, (b)(6), representatives from (b)(4) to discuss the possible root cause(s) for the migration.As all representatives from either parties ((b)(6) were not present at the procedure, all discussions were gathered from the information that was initially reported from the hospital to ms.(b)(6).One possible root cause was believed that the vessel may have dilated after the initial procedure on (b)(6) 2025 and the plug became dislodged from the target location.It was also assumed the migration did not appear to be a device deficiency and more of an anatomy anomaly, in their opinion.However, without further information or case images and videos, a definitive root cause could not be confirmed at this time.Furthermore, a review of the lot history record and associated lot release testing 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.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 an arteriovenous (av) shunt case on (b)(6) 2025 in taiwan, the physician implanted an imp-07 device near the wrist of the patient.When the patient returned for a follow-up on (b)(6) 2026 due to concerns of swelling, it was found the device had migrated proximally (up towards the elbow area) which occluded the main vessel.The physician performed a cut-down to remove the imp-07 device and it remains explanted from the patient.No serious clinical event occurred to the patient and the patient is stable.

• Brand Name: IMPEDE 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: 24318996
• Report Number: 3013353964-2026-00001
• Device Sequence Number: 10382015
• Product Code: KRD
• UDI-Device Identifier: 00810041650016
• UDI-Public: 00810041650016
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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-07
• Device Catalogue Number: IMP-07
• Device Lot Number: FR25072401E
• 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: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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