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

Model Number	IMP-FX-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/10/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024, dr.(b)(6) performed a stent on a hepatic artery and a sac fill of a gastroduodenal artery (gda) aneurysm where 70 imp-fx-12 plugs were placed using a 7f medtronic launcher guide catheter and 180cm amplatz s.S.Guidewire.The physician accessed the hepatic artery first using an 8f x 90cm terumo destination sheath which the 7f medtronic launcher was delivered into/through.The physician also used 3 gore viabahn vbx stents to eliminate perfusion of the gda aneurysm.At the end of the procedure, embolization was complete, there was no flow in the gda aneurysm, and no perfusion of the sac from the hepatic aneurysm.The procedure was completed, and the patient was in stable condition.The patient remained in the hospital per normal procedure, but 3 days later on (b)(6) 2024 experienced a rupture of the abdominal artery and the patient expired.Under computed tomography (ct) scan, the physician could not identify which artery was ruptured.It was reported that "dr.(b)(6) does not believe it was the gda that ruptured, given that it had been embolized and excluded, i.E., no longer perfused and pressurized by the hepatic artery.".
Additional Manufacturer Narrative
Based on the information received, the patient had undergone procedure on (b)(6) 2024 of a stent on a hepatic artery and a sac fill of a gastroduodenal artery (gda) aneurysm using imp-fx-12 devices.70 devices were deployed to the target site without any incident using a 7f medtronic launcher guide catheter and 180cm amplatz s.S.Guidewire.The physician accessed the hepatic artery first using an 8f x 90cm terumo destination sheath which the 7f medtronic launcher was delivered into/through.The physician also used 3 gore viabahn vbx stents to eliminate perfusion of the gda aneurysm.At the end of the procedure, embolization was complete, there was no flow in the gda aneurysm, and no perfusion of the sac from the hepatic aneurysm.The procedure was completed, and the patient was in stable condition.The patient had expired on (b)(6) 2024 due to a rupture of an abdominal artery.Under computed tomography (ct) scan, the physician could not make a determination (of which abdominal artery ruptured or why it ruptured) based on the information gained from the imaging study.It was reported that "(b)(6) does not believe it was the gda that ruptured, given that it had been embolized and excluded, i.E., no longer perfused and pressurized by the hepatic artery." no additional evaluation was performed at the time of the event as well as no autopsy or further examinations were performed to confirm the cause of death.A review of the lot history records and accompanying lot release reports identified no quality issues related to the device performance or indicative of a device malfunction which could be attributable to the event.However, without additional information the specific root cause associated with the event cannot be definitively determined.Note: two lots were used during treatment and there is only space on the 3500a form to list expiration and manufacturing dates for one lot.Below is the complete information for both lots.F24020501u (67 imp-fx-12 devices), manufacture date: 02/15/2024, expiration date: 05/15/2027.F22122104u (3 imp-fx-12 devices), manufacture date: 01/18/2023, expiration date: 01/18/2025.A supplemental report will be filed should additional information be received.Shape memory medical inc.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: 20838956
• Report Number: 3013353964-2024-00012
• Device Sequence Number: 7942028
• 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 Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: IMP-FX-12
• Device Lot Number: F24020501U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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: Death
• Patient Sex: Unknown