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

Model Number	IMP-FX-06
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A patient presented with a pavm (2.6 mm in diameter) which had recanalized after previously being embolized using coils (not manufactured by smm).An imp-fx-06 device was chosen for delivery to a site proximal to the previously implanted coils with no side branches in the vicinity.During 4f mp catheter withdrawal, the imp-fx plug migrated from the sub-segmental branch where it was deployed to another sub-subsegmental branch.It was reported the patient had experienced dyspnea once a day or two after the procedure, but now has a stable status.
Additional Manufacturer Narrative
The impede-fx device was being used to treat a pavm which recanalized and after deployment it migrated from the its target site (i.E., subsegmental branch of lateral middle lobe) and embolized a sub-subsegmental branch.Based on shape memory medical's (smm) review of the device deployment videos 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.; 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: 12844887
• Report Number: 3013353964-2021-00004
• Device Sequence Number: 14504461
• Product Code: KRD
• UDI-Device Identifier: 00810041650030
• UDI-Public: 00810041650030
• 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): 11/18/2021

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 Expiration Date: 03/15/2023
• Device Model Number: IMP-FX-06
• Device Catalogue Number: IMP-FX-06
• Device Lot Number: F21022203
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2021
• 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