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

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Pain (1994); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that embolism occurred.Obsidio was selected for use in a left gastric embolization procedure.The vessel size was 3mm or less.Approximately.3ml of the obsidio material was injected using a 2.8 french high flo microcatheter.Approximately.05ml of the obsidio material went distal as intended.Occlusion was reached very quickly.On the same day, obsidio was noted to have gone to the stomach.Necrosis occurred and the patient was sent to the operating room (or) to resect a small portion of the stomach that had the necrosis.The patient fully recovered.
Additional Manufacturer Narrative
Age at time of event: 18 years or older patient codes (5): added codes: pneumatosis, ischemia, pain, necrosis.Impact codes (1): updated from no health consequences or impact to additional surgery.
Event or Problem Description
It was reported that embolism occurred.Obsidio was selected for use in a left gastric embolization procedure.The vessel size was 3mm or less.Approximately.3ml of the obsidio material was injected using a 2.8 french high flo microcatheter.Approximately.05ml of the obsidio material went distal as intended.Occlusion was reached very quickly.On the same day, obsidio was noted to have gone to the stomach.Necrosis occurred and the patient was sent to the operating room (or) to resect a small portion of the stomach that had the necrosis.The patient fully recovered.It was further reported that the patient had a history of refractory upper gastrointestinal bleeding over at least 8 months.The patient was in and out of the hospital for these events and underwent multiple prior endoscopy procedures with clippings and empiric gastroduodenal artery embolization with coils.The patient was transferred to the hospital with persistent bleeding.Endoscopy was performed and demonstrated ulcerations throughout the gastric fundus.The patient underwent angiography which did not demonstrate active bleeding or other angiographic evidence of a source of bleeding.The gastroduodenal artery was occluded from the previous coils.The target lesion was located in the empiric left gastric artery.A total of 0.2-0.3 ml of obsidio was given via the renegade hiflo microcatheter.Initially the obsidio was injected slowly to allow it to flow more distally in the artery and then a more brisk injection was performed to obtain a more proximal occlusion.The aliquot technique was not utilized.The physicians were satisfied with the angiographic result and achieved the desired occlusion of the left gastric artery.The next morning, the patient complained of moderate mid-epigastric pain.The patient underwent a computerized tomography (ct) scan which demonstrated pneumatosis around the stomach and portal vein air.The patient underwent an emergency laparotomy and ischemia with demarcation was noted from the gastroesophageal junction through the gastric antrum.A gastrectomy was performed, and the patients abdomen was left opened for 3 days.This was followed by gastrojejunostomy and closure of the abdomen.The patient has done well since the surgery without any additional complications and no further gastrointestinal bleeding.

• 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: 18799209
• Report Number: 2124215-2024-11627
• Device Sequence Number: 7294466
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/08/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male