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

Model Number	IMP-FX-08
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A combination of impede and impede-fx devices were used to treat a pavm.After the physician delivered an impede and an impede-fx device to the first feeder vessel (5.7 mm diameter), residual sac flow coming from a second feeder vessel was observed.The physician then tried deploying an imp-fx-08 to occlude this vessel, however, possibly due to high flow in the vicinity, the device migrated to another vessel.Thereafter, having found no plug in the patient's carotid, the case was completed using another impede device and a ct scan performed afterwards located the missing imp-fx-08 device in the patient's hand.As of (b)(6) 2021, although the patient reported no complaints, it was decided that the plug would be removed via plastic surgery due to the appearance of a red spot on the skin of the patient's palm.
Additional Manufacturer Narrative
The impede-fx device was being used in the eu to treat a pavm and after deployment it migrated from the its target site and embolized a vessel in the patient's hand.Based on shape memory medical's review of the case angiograms provided, no root cause can be definitely attributed to the device migration.It is believed, but cannot be confirmed that the device migrated due to high flow in the vicinity of vessel it was deployed to.Note: 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 #: 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 eu and us impede-fx indications, smm is choosing to report this incident to the fda because of the general similarities between the two regions.A supplemental report will be filed should additional information be received from the complainant.

• Brand Name: IMPEDE-FX EMBOLIZATION PLUG
• Common Device Name: 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 ; 4086495175
• MDR Report Key: 12783717
• Report Number: 3013353964-2021-00003
• Device Sequence Number: 14511142
• Product Code: KRD
• UDI-Device Identifier: 00810041650047
• UDI-Public: 00810041650047
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K182390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMP-FX-08
• Device Catalogue Number: IMP-FX-08
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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