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

Model Number IMP-05

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 291294531
• Report Number: 3013353964-2021-00007
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: B054IMP051
• UDI-Public: B054IMP051
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN EMBOLIZATION COIL FROM ANOTHER COMPANY; UNKNOWN EMBOLIZATION COIL FROM ANOTHER COMPANY