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

Model Number	IMP-10
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This was a dissection patient that was going to be treated in stages surgically.This first stage involved carotid/subclavian (lsa) bypass and embolization with an imp-10.The lsa was funnel-shaped and estimated to be 9 - 13mm, and 10 - 11mm at the target location for embolization.A 5fr cook flexor sheath was used with the imp-10, a 6fr sheath was used with the abbott amplatzer.After the carotid/subclavian bypass, a sheath was introduced from the brachial into the lsa and an imp-10 was deployed as a stand alone device (no tevar) into the lsa target location.The imp-10 was undersized relative to the vessel and migrated from the lsa to the iliac bifurcation upon deployment.The physician commented that the flow dynamics likely changed in the lsa after the bypass, causing flow to be directed from the lsa down toward the aorta (as opposed to normal flow up higher in the lsa).This could have led to the plug migrating to the iliac bifurcation.An ensnare was used from the brachial access to retrieve the plug.After multiple attempts, the anchor coil of the imp-10 was successfully snared and the entire implant was brought back up to the lsa.Note that when the plug was removed through the sheath, the anchor coil was pulled out of the patient but the foam portion of the imp-10 was sheared off and left in the patient lsa.An amplatzer was placed in the original target zone for the lsa, positioned closer to the origin of the aorta, with the imp-10 foam sitting above it in the lsa and providing further embolization along the target vessel.The case was completed and no subsequent adverse event to the patient occurred.
Additional Manufacturer Narrative
The imp-10 was being used to emoblize a left subclavian artery (lsa).The explanted anchor coil portion of the device was discarded and not returned to smm, therefore it could not be physically assessed.No specific device deficiency was reported that could have led to the migration.The video provided from the case was reviewed and it was observed that, during deployment, the anchor coil was in a round, unconstrained configuration, and the device migrated immediately upon full deployment from the delivery sheath.Additionally, the product ifu indicates the imp-10 for use in vessel sizes with a diameter of 6-10 mm.The lsa was measured to be 10-11 mm at the start of the case.This indicates that the device was likely under-sized for the vessel, as the anchor coil is the portion of the device intended to prevent migration when appropriately sized.Regarding device separation, the separation was not an inherent device malfunction as it was caused by the attempted removal in response to the migration.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL, INC.; 807 aldo avenue; suite 109; santa clara CA 95054
• Manufacturer (Section G): SHAPE MEMORY MEDICAL, INC; 807 aldo avenue; suite 109; santa clara CA 95054
• Manufacturer Contact: kristen duckworth ; 807 aldo avenue; suite 109; santa clara, CA 95054 ; 4086495175
• MDR Report Key: 17739264
• Report Number: 3013353964-2023-00007
• Device Sequence Number: 6634388
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: 00810041650023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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 Expiration Date: 09/09/2025
• Device Model Number: IMP-10
• Device Lot Number: F22051301E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ABBOTT AMPLATZER VASCULAR PLUG 14/10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown