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

Model Number	IMP-05
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/18/2023
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 device performance.A benchtop investigation did not occur because the device was implanted in the patient and could not be returned to shape memory medical.Based on shape memory medical's review of received information and case images, the root cause for the unintended deployment into the aaa sac is unknown.The procedure was performed as intended per smm's impede embolization plug, instructions for use (ifu1067).The physician noted the anchor coil was deployed into the ima for several centimeters before it became very stiff, leading for it to recoil and the imp-05 plug bounced into the aaa sac instead of the intended ima target vessel.There is no reported malfunction of the device itself.The procedure was completed with stryker target and boston scientific interlock coils for ima and iia embolization and evar stenting in the aaa sac.The imp-05 plug remains implanted in its location in the aaa sac.No serious adverse event to the patient was reported.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
The plan for this procedure was that the patient was going to be treated in stages surgically.This first stage involved embolization of the inferior mesenteric artery (ima) with an imp-05 device.The physician used a terumo 4fr glidecath (0.038"/0.97mm) to deliver the imp-05 device in the target lesion (ima), but when it was attempted to be deployed into the vessel, it was close to the origin of the vessel within the aaa sac, and it was deployed in a non-target fashion into the aaa sac.The physician noted that the anchor coil had entered the ima several centimeters but was "very stiff and the device recoiled and bounced into the aaa sac." the physician decided to leave the imp-05 plug in place inside the aaa sac and then evar was performed with a stent graft deployment that secured the imp-05 plug between the stent and sac wall.The procedure was completed with stryker target and boston scientific interlock coils for ima and iia embolization and evar stenting in the aaa sac.The imp-05 plug remains implanted in its location in the aaa sac.No serious adverse event to the patient was reported.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer Contact: meghan reu ; 807 aldo ave.; suite 109; santa clara, CA 95054-2252
• MDR Report Key: 18163147
• Report Number: 3013353964-2023-00009
• Device Sequence Number: 12423664
• Product Code: KRD
• UDI-Device Identifier: 00810041650009
• UDI-Public: 00810041650009
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/17/2023

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: 09/20/2025
• Device Model Number: IMP-05
• Device Lot Number: F22052301E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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