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 Codes	Extravasation (1842); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/29/2024
Type of Reportable Event	Death
Event or Problem Description
Patient was being treated for type ii endoleak using impede-fx embolization plug (imp-fx-12) device.Transcaval access was gained and 70 plugs were delivered to the target site without any incident using a 6fr jr4 (cordis) sheath.After completion of the deployment while withdrawing the delivery sheath from the aortic access, the patients blood pressure immediately dropped.Resuscitation was started however the patient did not recover and expired.Note: this report is a supplement to mfr report number# 3013353964-2024-00003 identifying an additional suspect device imp-fx-12, lot#f23100701u.
Additional Manufacturer Narrative
Shape memory medical complaint reference number: (b)(4).Based on the information received, patient was being treated for type ii endoleak using imp-fx-12 devices on (b)(6) 2024.70 devices were deployed to the target site as intended without any incident using 6 fr jr4 cordis sheath.While withdrawing the delivery sheath from the aortic access, the patients blood pressure immediately dropped (~25mm systolic pressure drop).A venogram revealed a small extravasation from the ivc.A sacogram did not identify any rupture.Within a short period, patient flatlined.Resuscitation had started, however the patient did not recover and expired.No further information related to the patient's death could be obtained from the physician attending the case.Smm received the pre-op images and these were reviewed with a physician, not present at the case, who is an experienced clinical user and advisor of smm devices.No root cause for the incident could be established.A review of lot history record and accompanying lot release report identified no quality issues related to the device performance.Out of the 70 imp-fx-12 devices used for the treatment, 60 belong to lot#f23090101u and 10 belong to lot#f23100701u.This report identifies the additional suspect device, device 2: imp-fx-12, lot#f23100701u.Refer mfr report number# 3013353964-2024-00003 for the other suspect device (device 1: imp-fx-12, lot#f23090101u).A follow-up report will be filed if additional information is received.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL, INC.; 1321 ridder park dr., suite 10; san jose CA 95131
• Manufacturer (Section G): SHAPE MEMORY MEDICAL, INC.; 1321 ridder park dr., suite 10; san jose CA 95131
• Manufacturer Contact: meghan reu ; 1321 ridder park dr., suite 10; san jose, CA 95131
• MDR Report Key: 19126894
• Report Number: 3013353964-2024-00004
• Device Sequence Number: 7620968
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: F23100701U
• 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: 04/01/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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