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

Model Number	IMP-07
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient underwent bypass surgery to treat a popliteal aneurysm.Due to the presence of a patent popliteal vessel (7-8 mm diameter), the physician attempted embolization via delivery of an imp-07 device.After observing no vessel occlusion, an imp-fx-08 device was delivered to the same target area.Ten minutes after the imp-fx delivery, residual flow was still observed which resulted in several cook coils being used to complete the case.No adverse event to the patient was reported.Note: this form 3500a identifies the first suspected medical device (i.E., imp-07) involved with this case.An additional copy of form 3500a to identify the second suspected medical device (i.E., imp-fx-08) associated with this case.A supplemental report will be filed should additional information be received from the complainant.
Event or Problem Description
The patient underwent bypass surgery to treat a popliteal aneurysm.Due to the presence of a patent popliteal vessel (7-8 mm diameter), the physician attempted embolization via delivery of an imp-07 device.After observing no vessel occlusion, an imp-fx-08 device was delivered to the same target area.Ten minutes after the imp-fx delivery, residual flow was still observed which resulted in several cook coils being used to complete the case.No adverse event to the patient was reported.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL; 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: 13160195
• Report Number: 3013353964-2021-00006
• Device Sequence Number: 5411943
• Product Code: KRD
• UDI-Device Identifier: 00810041650016
• UDI-Public: +00810041650016
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMP-07
• Device Catalogue Number: IMP-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 01/04/2022
• 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
• Patient Sex: Unknown