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

Model Number	IMP-10
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, a physician at presidio ospedaliero san giovanni bosco - napoli was performing embolization of the hypogastric (internal iliac) artery prior to the placement of an aortic endoprosthesis (evar).The physician chose to use an imp-10 device to embolize the 4-5mm artery.The physician attempted to deliver two imp-10 devices with a 6fr-25cm terumo introducer sheath and 0.035" guidewire.No catheter was used.During the attempted delivery of the first imp-10 device, the device immediately became stuck after transferring from the device introducer into the terumo introducer sheath.The device was not able to be delivered to the target size and was removed with the terumo introducer sheath.During the delivery of the second imp-10 device, the physician was able to deliver the device to the target site, though some resistence during delivery was noted.The device malfunction was reported to kardia, who is shape memory medical's distributor in italy and subsequently kardia reported this information the manufacturer (shape memory medical).

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL, INC.; 807 aldo avenue; suite 109; santa clara, ca
• MDR Report Key: 10296338
• Report Number: 3013353964-2020-00004
• Device Sequence Number: 19457014
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: 00810041650023
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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 Expiration Date: 08/28/2020
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F19081201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1