MAUDE Adverse Event Report: BIOSPHERE MEDICAL S.A. EMBOSPHERE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	S020GH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Fever (1858); Hyperplasia (1906); Pain (1994); Ischemic Heart Disease (2493); Weight Changes (2607); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Back pain (4895)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This literature article describes multiple patient events.Separate complaint records and associated mdrs were initiated for the additional patients described in the publication to ensure all potentially reportable events were evaluated and documented appropriately.Study: birn, j., williams, t.R., croteau, d., schwartz, s., sturza, s., & getzen, t.(2013).Transarterial embolization of symptomatic focal nodular hyperplasia.Journal of vascular and interventional radiology, 24(11), 1647-1655.Https://doi.Org/10.1016/j.Jvir.2013.07.012 was reviewed during internal quality system activities.The publication describes focal nodular hyperplasia (fnh) procedures that have been associated with asymptomatic dissection of the celiac artery, postembolization syndrome, and chest pain.The 3 patients with pes are not reportable."clinically, 7 of the 12 patients (58%) had complete resolution of symptoms by the time of the first clinical follow-up visit after embolization, and 5 patients (42%) had a reduction in symptoms at the initial office visit after the procedure.Four patients had cessation of pain medication use after embolization, and one patient who required transdermal fentanyl required only oral hydrocodone/acetaminophen after embolization.Two patients required the same dose of nonnarcotic medica tion after embolization as was required before the procedure.Five patients did not require pain medication before embolization, and none required pain medication after the procedure." it is unknown which patients received which pain medication routines.F 23 patient experienced ruq and back pain, and asymptomatic celiac dissection at the first attempt and postembolization syndrome after a successful second attempt.F 30 patient experienced ruq pain, weight loss, and chest pain with a negative work-up requiring a 4-day hospitalization.This remained unexplainable even after an exhaustive work-up and was considered a major complication.F 48 this patient experienced abdominal pain and post embolization syndrome.A successful planned resection was completed 2 months after the embolization.
Additional Manufacturer Narrative
This event was identified during internal quality system activities involving retrospective review of literature sources.Upon review, the manufacturer determined the event meets applicable medical device reporting criteria and is submitting this report to ensure completeness of complaint and mdr documentation.This submission does not represent new information regarding device performance or a change in the known risk profile of the device.The suspect device was not returned for evaluation.Device lot information was not available from the publication; therefore, a review of manufacturing records and complaint trending specific to the device lot could not be performed.Based on the information available from the literature source, the complaint could not be confirmed, and a definitive root cause could not be determined.

• Brand Name: EMBOSPHERE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BIOSPHERE MEDICAL S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 25828403
• Report Number: 9615728-2026-00096
• Device Sequence Number: 9999473
• Product Code: KRD
• UDI-Device Identifier: 00884450402948
• UDI-Public: 00884450402948
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K181300
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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 Catalogue Number: S020GH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown