MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83910
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deployed coil protruded from the target lesion.An embold fibered detachable coil system was selected for use in the inferior mesenteric artery (ima) to treat the abdominal aortic aneurysm.After successfully placing three embold fibered detachable coils of the same size within the ima, there was resistance encountered when the fourth coil was advanced.The fourth coil was attempted to be removed, but the tip of the coil was stuck, and the coil subsequently unraveled.The coil was deployed within the aneurysm, but protruded from the target lesion within the ima into the aorta.A stent graft was placed to complete treatment of the abdominal aortic aneurysm.The procedure was completed, and there were no adverse consequences reported for the patient.
Event or Problem Description
It was reported that the deployed coil protruded from the target lesion.An embold fibered detachable coil system was selected for use in the inferior mesenteric artery (ima) to treat the abdominal aortic aneurysm.After successfully placing three embold fibered detachable coils of the same size within the ima, there was resistance encountered when the fourth coil was advanced.The fourth coil was attempted to be removed, but the tip of the coil was stuck, and the coil subsequently unraveled.The coil was deployed within the aneurysm, but protruded from the target lesion within the ima into the aorta.A stent graft was placed to complete treatment of the abdominal aortic aneurysm.The procedure was completed, and there were no adverse consequences reported for the patient.It was further reported that the aneurysm was located around the origin of the ima rather than within the ima.It was also clarified that the resistance that was encountered with the fourth embold was felt during coil deployment rather than during coil advancement.Additional information confirmed that the stent graft fully trapped the unraveled coil within the aneurysm.Finally, all four coils that were placed within the aneurysm successfully embolized the ima.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16818056
• Report Number: 2124215-2023-19905
• Device Sequence Number: 15227797
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: 08714729983613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 10/02/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030262945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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