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

Model Number	83910
Medical Device Problem Codes	Separation Failure (2547); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the deployed coil extended into a non-intended location, which interfered with subsequent planned stent graft placement.An embold fibered 10x50 was selected for use in the endovascular aneurysm repair procedure.The target lesion was an abdominal aortic aneurysm located in the internal iliac.The internal iliac bone was embolized with preoperative embolism.The lesion was accessed via a contralateral approach from the upper and lower glute of the right internal iliac to the internal iliac aneurysm entry site.The embold delivery system was advanced through a breakthrough 2 marker microcatheter.When the embold coil was at the aneurysm entry, the coil did not release, despite the couplers being advanced past the microcatheter tip.The proximal release perforation was not broken.After advancing and retracting the coil several times, it eventually detached, but a portion of the coil protruded into the common iliac bifurcation, outside of the intended deployment site.The protruding portion of the coil interfered with subsequent planned stent graft placement.However, the stent graft was eventually successfully placed.There was no reported patient injury.
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.No components were sent back for analysis except for the delivery wire.The perforations were broken.The proximal couple showed no damage.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for failure to separate since the coil was implanted.
Event or Problem Description
It was reported that the deployed coil extended into a non-intended location, which interfered with subsequent planned stent graft placement.An embold fibered 10x50 was selected for use in the endovascular aneurysm repair procedure.The target lesion was an abdominal aortic aneurysm located in the internal iliac.The internal iliac bone was embolized with preoperative embolism.The lesion was accessed via a contralateral approach from the upper and lower glute of the right internal iliac to the internal iliac aneurysm entry site.The embold delivery system was advanced through a breakthrough 2 marker microcatheter.When the embold coil was at the aneurysm entry, the coil did not release, despite the couplers being advanced past the microcatheter tip.The proximal release perforation was not broken.After advancing and retracting the coil several times, it eventually detached, but a portion of the coil protruded into the common iliac bifurcation, outside of the intended deployment site.The protruding portion of the coil interfered with subsequent planned stent graft placement.However, the stent graft was eventually successfully placed.There was no reported patient injury.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17351729
• Report Number: 2124215-2023-37271
• Device Sequence Number: 5206061
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: 08714729983651
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 01/17/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030876583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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: BREAKTHROUGH 2 MARKER MICROCATHETER; BREAKTHROUGH 2 MARKER MICROCATHETER
• Patient Sex: Unknown