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

Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Ischemia (1942); Necrosis (1971); Sepsis (2067); Multiple Organ Dysfunction Syndrome (3261); Embolism/Embolus (4438); Pancreatitis (4481)
Date of Event	02/09/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B3: date of event: the procedure date was between 9th and 12th february 2024.Jason s.Kim, md, r.Peter lokken, md, mph, alexander lam, md, neslihan kayraklioglu, md, phd, k.Pallav kolli, md."gastroduodenal artery embolization with shear-thinning conformable embolic resulting in pancreatic and duodenal necrosis".Journal of vascular and interventional radiology, 1- 17.
Event or Problem Description
It was reported via journal article, that migration occurred resulting in patient complications and death.Obsidio was selected for an embolization procedure of the posterior superior pancreaticoduodenal artery (pspda).The patient was admitted for hypoxemic respiratory failure and sweets syndrome, and the hospital course was complicated by melena.The patients hemoglobin declined overnight from 7.1 to 5.8 g/dl with recurrent melena and hematemesis requiring a blood transfusion.A computerized tomography (ct) angiogram demonstrated active extravasation into the duodenum.Angiography of the pspda with a 2.8 french non-boston scientific microcatheter demonstrated a pseudoaneurysm of a small branch where super selective catheterization was impossible.Embolization of the pspda using obsidio was performed, with the goal of occluding branches beyond the reach of the microcatheter.The aliquot technique was utilized to preserve the microcatheter for later use.While applying a slow injection force, 0.2 ml aliquots of obsidio was flushed with a 3 ml syringe and iohexol, which was surmised to better resemble the viscosity of obsidio compared to normal saline.The embolic was administered until opacification of the pseudoaneurysm was achieved, delivering a total of 0.4 ml.Fluoroscopic images demonstrated the embolic deposited in the pseudoaneurysm and distal branches measuring 0.2 to 0.3 mm in caliber, while forming a cast of the parent vessel.Angiography of the gastroduodenal artery (gda) demonstrated continued extravasation from a separate branch.Obsidio was therefore administered with a more forceful injection, with the intention of achieving gda occlusion without additional distal embolization, using 0.2 ml aliquots for a total of 0.6 ml.Although distal penetration with subsequent flushing was not directly observed, the embolic penetrated into the right gastroepiploic artery and other terminal branches measuring 0.4 mm; no reflux was appreciated.The patients post procedure course was complicated by abdominal pain and white blood cell count of 52,000/microliters, lipase of 240 u/l, and lactate dehydrogenase of 601 u/l.A ct of the abdomen/pelvis obtained on post procedure day 3, showed regional nonenhancement of the duodenum and pancreatic head.The patient was emergently taken for exploratory laparotomy where complete necrosis of the second portion of the duodenum and severe pancreatitis of the pancreatic head were observed.The necrotic duodenum was resected.The patient remained in critical condition with the postoperative course complicated by sepsis and multi-organ failure.The patient was transitioned to comfort care and succumbed 18 days after embolization.

• 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): OBSIDIO, INC.; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21696264
• Report Number: 2124215-2025-17223
• Device Sequence Number: 9282269
• Product Code: KRD
• UDI-Device Identifier: 00191506039332
• UDI-Public: 00191506039332
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.8F PROGREAT TERUMO
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female