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

Model Number	IMP-FX-12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Abdominal Pain (1685); Malaise (2359)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the lot history records and accompanying lot release reports identified no quality issues related to device performance.A benchtop investigation could not occur because the devices remain implanted in the patient.Based on the information received thus far, no root cause can definitively be attributed to the device migration.The impede-fx us instructions for use also 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 possible, but cannot be confirmed, that the devices migrated outside of the aortic wall due to the previously identified vessel perforation and high flow in the vicinity of the vessel it was deployed to.The patient is in stable condition and no clinical sequelae has been reported since the follow up ct scan.A supplemental report will be filed should additional information be received from the complainant.Note: in the us, the impede-fx is indicated for use with the impede embolization plug to obstruct or reduce the rate of blood flow in the peripheral vasculature; this means impede-fx must be used with the impede (510k number: k181051) to mitigate migration risks.It was not communicated that an impede embolization plug was used in this case.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.F23092601u manufacture date: 10/02/2023, expiration date: 01/02/2027.F23100701u manufacture date: 10/24/2023, expiration date: 01/24/2027.Shape memory medical complaint reference number: (b)(4).
Event or Problem Description
The devices were being used to treat an endoleak.After initial access, it was observed via angiography that there was a perforation in the aortic wall caused by the bentson wire being used.70 imp-fx-12 plugs were then delivered, and it was noted the perforation appeared to have resolved with the delivery of the impede-fx devices.The remainder of the case was uneventful, and no abnormalities were noticed during imaging.The patient reported having lower left quadrant pain and malaise post-operation.A follow up ct was conducted in response to the llq pain, which had improved but had not entirely resolved since the procedure.During the ct, it was observed that several imp-fx-12 plugs (approximately 5-10) had migrated outside of the aortic wall.There was no intervention to address the migrated plugs and the latest update is that the patient is in stable condition.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE, PRODUCT CODE: KRD
• 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
• MDR Report Key: 19262166
• Report Number: 3013353964-2024-00005
• Device Sequence Number: 11408496
• Product Code: KRD
• UDI-Device Identifier: 10810041650051
• UDI-Public: 10810041650051
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: F23092601U, 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: 04/18/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT GRAFT. MFG/MODEL UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown