MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES; EMBOSPHERES

Model Number	00884450116715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that a tumor embolization was performed using embolic devices within the middle meningeal artery 2 days before scheduled craniotomy surgery.Later on a craniotomy involving the contralateral side was performed, followed by rumor resection (simpson grade, ii).Dural defects were closed with duragen.Pathological diagnosis was transitional meningioma (who grade, i).No new neurological symptoms appeared, but sensory disturbance and paresis in the left upper and lower extremities developed 8 days after surgery.Mri showed cerebral infarction in the right parietal lobe.Cerebral venous thrombosis (cvt) was suspected, and drip infusion of heparin was started.Twelve hours later, however, seizures occurred on the left side of the body, and movement disorder (manual muscle testing, 2/5) and sensory disturbance on the left side of the body, left unilateral spatial neglect and apraxia developed.Mri showed that the infarct area in the right temporal lobe had become hemorrhagic, and magnetic resonance venography (mrv) revealed stenosis of the superior sagittal sinus just beneath the site of craniotomy.Superior sagittal sinus thrombosis was thus diagnosed.Drip infusion of heparin at 10000-12000 units/day was started, and then switched to direct oral anticoagulant (doac) therapy 1 week later.Blood testing showed no thrombotic predisposition.Mrv performed 3 weeks later showed recanalization of the superior sagittal sinus.The patient was transferred to another hospital with persisting left hemiplegia and sensory disturbance (modified rankin scale, grade 3) one and a half months after surgery.

• Brand Name: EMBOSPHERE MICROSPHERES
• Common Device Name: EMBOSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations-383; rue de la belle etoile; zi paris nord ii, roissy en 95700 ; FR 95700
• MDR Report Key: 12013323
• Report Number: 9615728-2021-00037
• Device Sequence Number: 19659175
• Product Code: NAJ
• UDI-Device Identifier: 00884450116715
• UDI-Public: 00884450116715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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 Model Number: 00884450116715
• Device Catalogue Number: EMBOSPHERE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR