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

Model Number	IMP-10
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A left subclavian artery was being embolized using an imp-10 device.Ultimately, the device was deployed with the anchor coil component stretched out in the trajectory spanning from the subclavian, axillary and humeral artery, and the foam plug component was in the brachial artery.No adverse event to the patient occurred.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 no device components were returned to shape memory medical (smm).Based on smm's review of the information received, the most probable root cause for this event is being attributed to the physician's usage of the imp-10 device in spite of the fact the temperature indicator label located on the device pouch had activated.The impede ifu states that if the temperature indicator label shows the temperature has been exceeded (i.E., the indicator dot is black), the device should not be used as the plug component of the device may have expanded imapcting delivery performance.This abnormal use coupled with the physician having difficulty advancing the device through the introducer likely led to the observations described in section b5, including the anchor coil not forming as expected, and the luer hub detaching from the introducer tubing.Smm reference number: (b)(4).
Event or Problem Description
An imp-10 device was being delivered using a 7fr destination sheath and a 0.035" amplatz wire to embolize a left subclavian artery.At the beginning of device delivery, the physician reported difficulties advancing the plug through the introducer, however, this later gave way.During device deployment, because the device anchor coil did not form as expected, the physician withdrew the destination sheath containing the imp-10 device.After removing the sheath, the physician ran a guidewire through the sheath lumen and to their surprise, the device introducer emerged.The imp-10 is supplied pre-loaded in an introducer to faciliate transfer into the delivery catheter/sheath.They determined that the luer hub may have detached from the introducer tubing earlier and that because of this, the introducer tubing unknowingly entered the destination sheath.Subsequent fluoroscopy found that the imp-10 device remained inside the patient.The imp-10 anchor coil was reported to stretched out and deployed in the trajectory spanning from the subclavian, axillary and left humeral artery.The foam plug component of the imp-10 device was in the brachial artery.However, no adverse event to the patient was reported.After the case was completed, it was additionally found that the temperature indicator label on the imp-10 device packaging had activated.

• 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
• Manufacturer (Section G): SHAPE MEMORY MEDICAL, INC.; 807 aldo ave.; suite 109; santa clara CA 95054
• Manufacturer Contact: meghan reu ; 807 aldo ave.; suite 109; santa clara, CA 95054
• MDR Report Key: 16456095
• Report Number: 3013353964-2023-00002
• Device Sequence Number: 6382416
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: +00810041650023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

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: 11/04/2023
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F21102901E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2021
• 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
• Patient Sex: Unknown