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

Model Number	IMP-FX-12
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with an aneurysm filled with fenestrated evar was being treated with smm plugs after placing the evar graft.While deploying the imp-fx-12 devices, it was noticed that some plugs had gone into the common iliac arteries.It was confirmed via intravascular ultrasound (ivus) that the plugs were within the lumen of the endograft.The endograft was relined with iliac extensions up to the renal arteries which jailed the plugs in the lumen.Two imp-fx-12 devices were noted in each internal iliac artery for a total of four implants.Insertion of an endograft extension within the original graft effectively 'jailed' the plugs between the original graft and endograft extension.
Additional Manufacturer Narrative
The manufacturing documentation for the lot associated with this incident could not be reviewed since the lot number was not provided.A benchtop investigation was not performed since the devices were implanted in the patient and could not be returned to shape memory medical.Based on shape memory medical's review of received information, the root cause for the unintended delivery of plugs to the lumen of the endograft is possibly due to the procedure where it was reported that the guidewire was unintentionally caught between the outside of the main body and the inside of the fenestrated endograft.Since the guidewire was placed in the unintended location, misdelivery of the plugs occurred, thereby requiring an endograft extension to jail the plugs.Without additional information, a root cause cannot be definitively confirmed.There was no device malfunction reported and guidewire used during the procedure is not manufactured by smm.The procedure was otherwise completed without incident and no serious adverse event to the patient was reported.A supplemental report will be filed should additional information be received from the complainant.Shape memory medical 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: 19997253
• Report Number: 3013353964-2024-00007
• Device Sequence Number: 7257556
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: COOK ZFEN EVAR GRAFT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown