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

Model Number 00884450116715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/15/2021

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations-383; rue de la belle etoile; zi paris nord ii, roissy en 95700 ; FR 95700
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12013323
• MDR Text Key: 256695151
• Report Number: 9615728-2021-00037
• Device Sequence Number: 1
• Product Code: NAJ
• UDI-Device Identifier: 00884450116715
• UDI-Public: 00884450116715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450116715
• Device Catalogue Number: EMBOSPHERE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR