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

Model Number	IMP-FX-12
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	11/07/2024
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 could not occur because the device remains implanted in the patient.Based on the information received thus far, no root cause can definitively be attributed to the device migration.Although, the impede-fx us instructions for use state, "physicians should exercise clinical judgement when using the impede-fx embolization plug in anatomy that may lead to unintended device placement and/or movement (i.E., high flow vasculature, large luminal vessel diameter)." it is believed, but cannot be confirmed that the device may have migrated due to high flow in the vicinity of the vessel it was deployed to.No adverse event to the patient has been reported thus far.However, a supplemental report will be filed should additional information be received from the complainant.Note: the impede-fx us indications for use also state that "the impede-fx embolization plug is indicated for use with the impede embolization plug to obstruct or reduce the rate of blood flow in the peripheral vasculature;" this means the impede-fx device is indicated to be used with the impede device (510k number: k181051) to mitigate migration risks.The patient was implanted with 7 imp-fx-12 devices only.Shape memory medical inc.Complaint reference number: (b)(4).
Event or Problem Description
On (b)(6) 2024, dr (b)(6) at (b)(6) performed an embolization of an ovarian vein where 6 of 7 imp-fx-12 plugs were delivered at the target site using a 6f cordis catheter.1 imp-fx-12 plug had migrated and landed in a sub-segmental pulmonary artery that was perfusing a small part of the lung.Dr (b)(6) opted not to attempt to retrieve the migrated plug as there was no patient sequelae.The procedure was completed and patient is in stable condition.No adverse event has been reported thus far.

• 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: 20791081
• Report Number: 3013353964-2024-00011
• Device Sequence Number: 20524214
• Product Code: KRD
• UDI-Device Identifier: 00810041650054
• UDI-Public: 00810041650054
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 02/06/2025
• Device Model Number: IMP-FX-12
• Device Lot Number: F23013101U
• 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: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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
• Patient Sex: Unknown