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

Catalog Number S420GH/JPA

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

Patient Problems Embolism (1829); Occlusion (1984)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that on (b)(6) 2016, the patient complained of blindness after embolization of a meningioma via the left middle meningeal artery.The patient's left central retinal artery occlusion was diagnosed on the basis of ophthalmologic evaluation performed after completion of the embolization procedure.The physician administered solu-medrol (iv, 1000 mg/day) and radicut (iv, 60 mg/day) until (b)(6) 2016.On (b)(6) 2016, the physician administered tandetron (iv, 80 mg/day) as well.On (b)(6) 2016, the patient was transferred to another hospital where she received hyperbaric oxygen therapy until (b)(6) 2016.On (b)(6) 2016, the patient was transferred to the reporter's hospital again to undergo craniotomy for meningioma, as treatment for blindness in the acute phase had been completed.On (b)(6) 2017, resection of meningioma was performed.On (b)(6) 2017, no change was noted in blindness in the left eye, and the patient was discharged home.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint database and device history record could not be reviewed since the lot number was not provided.

• Brand Name: BIOSPHERE EMBOSPHERE MICROSPHERES
• Type of Device: MICROSPHERES,
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en, 95700 ; FR 95700
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6544312
• MDR Text Key: 74417754
• Report Number: 9615728-2017-00016
• Device Sequence Number: 1
• Product Code: HCG
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

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
• Device Operator: Physician
• Device Catalogue Number: S420GH/JPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• 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
• Treatment: ANESTHESIA
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 55