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

Model Number IMP-FX-06

Device Problems Insufficient Information (3190); Activation Failure (3270)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

An avm in the arm (approximately 3-5 mm diameter) was being treated using a combination of smm products.After deploying an imp-07 to the 1st vessel (4.65 mm diameter), the physician deployed an imp-05 device to the 2nd vessel (3.62 mm diameter).Following this, an imp-fx-06 was delivered to the 3rd vessel (diameter unspecified).Five minutes after the imp-fx-06 device was deployed, angiography confirmed the 2nd and 3rd lesions had completely embolized; however, because residual flow was still observed in the 1st vessel, an imp-fx-06 device was delivered to the same area as the imp-07 device.There was "good embolization post-procedure" and no adverse events to the patient were reported.

Manufacturer Narrative

During treatment of an avm, residual flow was reported in the vessel where an imp-07 device was implanted.This required delivery of an additional shape memory medical device, an imp-fx-06.No adverse event to the patient was reported.A review of the lot history record and accompanying lot release report identified no quality issues related to device performance.Additionally, review of the case images provided found that the device was deployed as intended.Based on the information received thus far, no root cause can be attributed to this incident.A supplemental report will be filed should additional information be received from the complainant.Shape memory medical complaint reference number:(b)(4).

Manufacturer Narrative

The vessel treated on (b)(6) 2023 used two shape memory medical devices: imp-07 and imp-fx-06.The imp-07 device details can be found in the form 3500a report dated 11/3/23.This supplemental report contains the imp-fx-06 device details.Review of the imp-fx-06 lot history record and accompanying lot release report identified no quality issues related to device performance.Additionally, review of the case images provided from the follow-up on (b)(6) 2024 returned no findings.Based on the information received thus far, no root cause can be attributed to this incident.Shape memory medical complaint reference number: (b)(4).The impede-fx indications for use in the eu and us are different.In the eu, the impede-fx is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.Comparatively, 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.In both the eu and us, impede-fx is used for peripheral vessel embolization and is identical with regards to form, fit and function.Therefore, regardless of the differences in the indications for use in eu and us, smm is choosing to report this incident to fda because of the general similarities between the two regions.

Event Description

An imp-07 and imp-fx-06 device were used in a case in (b)(6) to treat an avm on (b)(6) 2023.Embolization was confirmed at the end of the procedure.During a follow-up visit on (b)(6) 2024, it was found that the vessel had recanalized which required re-intervention to deliver additional embolic devices (i.E., cook nester coils).The patient status was report stable.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer Contact: meghan reu ; 807 aldo ave.; suite 109; santa clara, CA 95054-2252
• MDR Report Key: 18116437
• MDR Text Key: 328164342
• Report Number: 3013353964-2023-00008
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00810041650030
• UDI-Public: 00810041650030
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K181051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMP-FX-06
• Device Lot Number: F21090201E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention