MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBSIDIO?; VASCULAR EMBOLIZATION DEVICE

Model Number	M0013972101010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that migration occurred resulting in non target embolization requiring additional intervention.Obsidio was selected for an embolization procedure.The subject underwent the index procedure on (b)(6) 2024.The target lesion was located in the gastroduodenal artery with a vessel diameter of 4 mm.The gastroduodenal artery was embolized using a non-boston scientific microcatheter with 1 ml of obsidio conformable embolic using standard delivery (non-aliquot) technique.During the procedure, a small amount of obsidio in the proximal gastroduodenal artery migrated in a retrograde fashion to the hepatic artery and then migrated to small distal hepatic arterial branches.There was no change in liver perfusion observed due to non-target embolization to the hepatic arteries.Post embolization with obsidio, penumbra coil was used in the proximal gastroduodenal artery to complete the embolization.The target vessel was occluded within the expected area after embolization with obsidio embolic via angiography.On (b)(6) 2025, the subject was discharged.
Event or Problem Description
It was reported that migration occurred resulting in non-target embolization requiring additional intervention.Obsidio was selected for an embolization procedure.The subject underwent the index procedure on (b)(6) 2024.The target lesion was located in the gastroduodenal artery with a vessel diameter of 4 mm.The gastroduodenal artery was embolized using a non-boston scientific microcatheter with 1 ml of obsidio conformable embolic using standard delivery (non-aliquot) technique.During the procedure, a small amount of obsidio in the proximal gastroduodenal artery migrated in a retrograde fashion to the hepatic artery and then migrated to small distal hepatic arterial branches.There was no change in liver perfusion observed due to non-target embolization to the hepatic arteries.Post embolization with obsidio, penumbra coil was used in the proximal gastroduodenal artery to complete the embolization.The target vessel was occluded within the expected area after embolization with obsidio embolic via angiography.On (b)(6) 2025, the subject was discharged.It was further reported that prior and post embolization with obsidio comformable embolic, the target vessel was embolized using penumbra coil to complete the embolization of the proximal gastroduodenal artery.The penumbra coil was deployed only to complete the anatomic embolization of the gda stump after a small amount of obsidio migrated away from this location.However, the target vessel was already appropriately occluded prior to coil deployment.
Event or Problem Description
It was reported that migration occurred resulting in non target embolization requiring additional intervention.Obsidio was selected for an embolization procedure.The subject underwent the index procedure on (b)(6) 2024.The target lesion was located in the gastroduodenal artery with a vessel diameter of 4 mm.The gastroduodenal artery was embolized using a non-boston scientific microcatheter with 1 ml of obsidio conformable embolic using standard delivery (non-aliquot) technique.During the procedure, a small amount of obsidio in the proximal gastroduodenal artery migrated in a retrograde fashion to the hepatic artery and then migrated to small distal hepatic arterial branches.There was no change in liver perfusion observed due to non-target embolization to the hepatic arteries.Post embolization with obsidio, penumbra coil was used in the proximal gastroduodenal artery to complete the embolization.The target vessel was occluded within the expected area after embolization with obsidio embolic via angiography.On (b)(6) 2025, the subject was discharged.It was further reported that prior and post embolization with obsidio comformable embolic, the target vessel was embolized using penumbra coil to complete the embolization of the proximal gastroduodenal artery.The penumbra coil was deployed only to complete the anatomic embolization of the gda stump after a small amount of obsidio migrated away from this location.However, the target vessel was already appropriately occluded prior to coil deployment.It was further reported that digital subtraction angiography (dsa) revealed a fragment of the obsidio column had separated from the rest of the column and had migrated upward to be closer to the gda origin and non target embolization to hepatic arteries.A few second later it was observed with fluoroscopy that the fragment refluxed completely into the proper hepatic artery, broken apart, and showered to a few distal hepatic artery branches.

• Brand Name: OBSIDIO?
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21365457
• Report Number: 2124215-2025-07583
• Device Sequence Number: 15569515
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: (01)00191506043124(17)250729(10)34523922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2025
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0034523922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 04/21/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/01/2025; 05/19/2025
• Date Device Manufactured: 07/29/2024
• 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: MICROCATHETER: TERUMO PROGREAT.; MICROCATHETER: TERUMO PROGREAT.; MICROCATHETER: TERUMO PROGREAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White