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	Foreign Body Embolism (4439)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An internal iliac artery was being embolized using an imp-10 device.Ultimately, the device was unintentionally deployed in the common iliac and migrated to the femoral during a planned evar procedure.The imp-10 was surgically explanted and no subsequent 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 the device was discarded and could not be returned to shape memory medical.Based on the information received, the most probable root cause for this event are complications stemming from patient anatomy (high angulation due to necessary ipsalateral approach) and interaction with the gore excluder stent graft also used in the procedure.There is no reported malfunction of the device itself.Smm reference number: (b)(4).
Event or Problem Description
Evar was planned in combination with internal iliac artery (iia) embolization to treat an endoleak.The aim was to first embolize the iia (~ 9-9.5 mm in diameter) with an imp-10 device.Access was gained ipsalaterally, from the external iliac to the internal iliac.Because of this approach, there was a high degree of angulation (more than 90 degrees).A medtronic launcher jr 6f was used for delivery.A 6f launcher was placed in the iia and had an s-curve configuration.There was difficulty in navigating the plug through the s-curve.The plug was forwarded to the end of the curve using a stiff wire.At this point, because of too little support in the iia, the catheter lost position and the plug was unintentionally deployed in the common iliac.All of this occurred within the working time.Evar was performed and the physician decided to "over-stent" the imp-10 in the common iliac to prevent further migration and secure the imp-10 between the stent and the vessel wall.During evar, the plug migrated distally and embolized the common femoral.After evar, the plug was removed from the femoral surgically, in one piece, by opening the groin, clamping the artery, and extracting.The plug was discarded.The patient was stable during the entire procedure and was successfully extubated at the end.No subsequent adverse events occurred.

• 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 ; 8177232386
• MDR Report Key: 17447132
• Report Number: 3013353964-2023-00004
• Device Sequence Number: 7260303
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: 00810041650023
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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: 11/04/2023
• Device Model 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: 07/05/2023
• Initial Report FDA Received Date: 08/02/2023
• 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: GORE EXCLUDER (STENT GRAFT FOR EVAR)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown