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

Model Number	IMP-FX-12
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, dr (b)(6) at (b)(6) performed an embolization of an aberrant subclavian artery where an imp-10 was placed in the vessel and an fx-12 was added behind the imp-10, which were both placed using a 6 fr.Flexor sheath.Upon obtaining an angiogram, it was discovered that the fx-12 had migrated past the imp-10, and was now sitting in the right distal subclavian artery.An en snare was advanced, and the plug was captured.While retracting the plug back, it was released at the same level as the anchor coil of the imp-10.He decided to leave it there, then proceeded with the procedure.As part of treating the aberrant subclavian artery, two (2) terumo relay thoracic grafts were placed across the ostium of the aberrant subclavia and a right carotid to right subclavian bypass was performed.While interrogating the results of the procedure, the fx-12 was noticed to have migrated again to the right axillary area.The migrated plug was snared and removed from the patient via the exposed carotid subclavian bypass.It is possible that the entire polymer portion of the plug was not fully removed.The patient is stable and had good perfusion to the hand, as measured by pulse-oximeter.Post op treatment is to monitor the patient, and the physician confirmed that this is not a device related event and is related to the technique/procedure.
Additional Manufacturer Narrative
The manufacturing documentation for the lot associated with this incident could not be reviewed since the lot number was not provided.A benchtop investigation was not performed since the device was not returned to shape memory medical.Based on shape memory medical's review of received information, the root cause for the migration of the imp-fx-12 plug could possibly be due to imp-10 not completely expanding before placing the imp-fx-12.Without additional information, a root cause cannot be definitively confirmed.There was no malfunction reported and 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.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 ; 4086495175
• MDR Report Key: 20752516
• Report Number: 3013353964-2024-00009
• Device Sequence Number: 14552919
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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
• Device Model Number: IMP-FX-12
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RELAY THORACIC GRAFTS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown