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

Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history record for (b)(6) was reviewed and identified no quality issues related to device performance.A benchtop investigation was unable to occur because the imp-fx-12 devices remained 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 aorta due to high flow in the vicinity of the vessel it was deployed to.Flow was restored to the patient, no other issues were noted during the case, and no clinical sequelae has been reported since.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.Shape memory medical complaint reference number: (b)(4).
Event or Problem Description
This was a follow up case/re-treatment, performed on (b)(6) 2024, to treat a chronic endoleak.The original case took place on (b)(6) 2024.During the original case, 30 imp-fx-12 plugs were used to treat the endoleak.During follow up/re-treatment on (b)(6) 2024, it was discovered that two imp-fx-12 plugs from the original case had migrated from the aorta to the internal iliac and renal arteries.Flow was restored to the internal iliac with a stent.Flow was available to the kidney via side branches, so no additional measures were taken regarding the implant in the renal artery.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL; 1321 ridder park drive; suite 10; san jose CA 95131
• Manufacturer (Section G): SHAPE MEMORY MEDICAL; 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: 20346964
• Report Number: 3013353964-2024-00008
• Device Sequence Number: 8000206
• Product Code: KRD
• UDI-Device Identifier: 10810041650051
• UDI-Public: 10810041650051
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/01/2024

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
• 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: 09/13/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: NESTER COILS, MWCE-35-20-16 (QTY: 2); STENT GRAFT. MFG/MODEL UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown