MAUDE Adverse Event Report: OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE

Lot Number	0000320231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Unspecified Tissue Injury (4559)
Date of Event	09/01/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient death occurred.Obsidio was selected for use in a terminal ileal bleed.The aliquot technique was used with contrast and the vessel size was 2mm.The device was successfully implanted into two branches off of the ileocolic artery.A bowel infarction was noticed on post computerized tomography (ct) imaging.Approximately four days post procedure, the patient experienced pneumatosis and underwent surgery for a partial bowel resection.The patient remained hospitalized until passing away.
Additional Manufacturer Narrative
H6 patient codes (2): unspecified tissue injury is pneumatosis.
Event or Problem Description
It was reported that a patient death occurred.Obsidio was selected for use in a terminal ileal bleed.The aliquot technique was used with contrast and the vessel size was 2mm.The device was successfully implanted into two branches off of the ileocolic artery.A bowel infarction was noticed on post computerized tomography (ct) imaging.Approximately four days post procedure, the patient experienced pneumatosis and underwent surgery for a partial bowel resection.The patient remained hospitalized until passing away.It was further reported that the documented cause of death was respiratory failure and cardiac arrest.
Additional Manufacturer Narrative
H6 patient codes (2): unspecified tissue injury is pneumatosis.H6: evaluation method codes (2): added analysis of production records code.B5: describe event or problem: updated.B2: date of death: date added.

• Brand Name: OBSIDIO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OBSIDIO, INC.; 2 scimed pl; maple grove 55331
• Manufacturer (Section G): OBSIDIO; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18769491
• Report Number: 2124215-2024-09635
• Device Sequence Number: 7795798
• Product Code: KRD
• UDI-Device Identifier: 00191506039332
• UDI-Public: 00191506039332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Lot Number: 0000320231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Age: 43 YR
• Patient Sex: Male