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

Model Number	IMP-05
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This imp-05 was used to perform a iia embolization in a common iliac artery aneurysm (ciaa).Access to the target site was through the superior gluteal artery using a judkins catheter 4fr (0.038 inch inner diameter).The physician used a radifocus guidewire (0.035 inch outer diameter) to deliver the imp-05 through the catheter.The impede proximal markerband could not be confirmed in the catheter under fluoroscopy during delivery, even when the radifocus guidewire was pulled back for better visibility.After the anchor coil portion of the imp-05 was deployed, the physician was then able to visualize the impede proximal markerband under fluoroscopy, and found that the foam had separated from the anchor coil.The physician then chose to deliver both the anchor coil and the foam, separate, into the blood vessel.Another coil (not manufactured by smm) was then delivered, complete embolization was achieved and the operation was completed.This event did not result in any harm to the patient.
Additional Manufacturer Narrative
The lhr for lot f20091405 was reviewed and there were no anomalies or unresolved ncrs found that would suggest issues with the foam to nitinol adhesive bond.Tr1432, the lot release test report for this lot, was also reviewed and it was confirmed that all 29 bond verification samples passed testing and were successfully delivered into the simulated use fixture.Without the device being returned for investigation, no root cause can definitively be attributed to the imp-05 foam to anchor coil separation.

• 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 2254
• Manufacturer Contact: meghan reu ; 807 aldo ave; suite 109; santa clara, CA 95054-2254 ; 4086495175
• MDR Report Key: 13122570
• Report Number: 3013353964-2021-00007
• Device Sequence Number: 13970943
• Product Code: KRD
• UDI-Device Identifier: B054IMP051
• UDI-Public: B054IMP051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 05/08/2022
• Device Model Number: IMP-05
• Device Catalogue Number: IMP-05
• Device Lot Number: F20043001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN EMBOLIZATION COIL FROM ANOTHER COMPANY; UNKNOWN EMBOLIZATION COIL FROM ANOTHER COMPANY
• Patient Sex: Unknown