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

Lot Number	0001219231
Medical Device Problem Codes	Material Separation (1562); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that insufficient formation and fragmentation of obsidio occurred requiring additional intervention.Obsidio was selected for a transcatheter embolization procedure of the left deep circumflex iliac artery.The patient had a history of a 10 cm ruptured left common iliac artery aneurysm and underwent open repair.Prior to the date of the current procedure (b)(6) 2024), the patient underwent right internal iliac artery embolization and percutaneous embolization of a significant endoleak related to the left iliac artery aneurysm.Due to a persistent type ii endoleak, the physician planned transcatheter embolization of the left deep circumflex iliac artery via a right common femoral artery approach.A microcatheter was placed coaxially greater than 10 cm into the left deep circumflex iliac artery.The vessel size was approximately 2.5mm.Arteriography revealed communication between the endoleak cavity and the left iliac vein.Following arteriography, embolization was performed with one syringe of obsidio using standard technique.Fluoroscopy revealed no obsidio in the target vessel.Subsequent embolization was performed using 2 x 3mm coils.Computerized tomography (ct) imaging following the procedure revealed most of the obsidio in the endoleak cavity and small foci of obsidio in the pulmonary artery branches.The patient did not experience any clinical sequelae related to the procedure or non-target embolization.Due to the size and complexity of the endoleak, the patient has undergone subsequent transcatheter embolization procedures.The patient fully recovered.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.

• 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: 19393618
• Report Number: 2124215-2024-31830
• Device Sequence Number: 15391891
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Lot Number: 0001219231
• 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: 05/06/2024
• Initial Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 12/19/2023
• 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
• Patient Sex: Unknown