MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES; AGENTS, EMBOLIC, TREAT. UTER. FIBRO.

Catalog Number S420GH

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

Patient Problem Death (1802)

Event Date 04/25/2014

Event Type  Death  

Event Description

It has been reported that patient with hepatocellular carinoma (stage iii) died one day after having received trans-arterial embolization with the device.On (b)(6) 2014, 2 syringes of embosphere were used for trans-arterial embolization.Exacerbation of difficulty breathing and malaise was noted, and despite initiation of continuous hemo-filtration (chr) and acidosis progressed.On (b)(6) 2014, the patient died.The cause of death was considered to be the progression of acidosis associated with massive tumor sell lysis in the presence of multiple tumors and hepatic cirrhosis.

Manufacturer Narrative

The patient's test results performed on (b)(6) 2014, before the device was used, already showed deteriorated liver function.The cause of death was considered to be the progression of acidosis associated with massive tumor sell lysis in the presence of multiple tumors and hepatic cirrhosis.Causal relationship between tumor lysis syndrome and device has not been found.Since the lot humber was not provided, the device history record and complaint database could not be reviewed.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, TREAT. UTER. FIBRO.
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; roissy en france ; FR
• Manufacturer Contact: alix fonlladosa ; parc des nations, paris nord 2 383; rue de la bella etoie; roissy en france 95300 ; FR 95300 ; 48172529
• MDR Report Key: 4336967
• MDR Text Key: 5218464
• Report Number: 9615728-2014-00004
• Device Sequence Number: 1
• Product Code: NAJ
• 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: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S420GH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2014
• 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): Death
• Patient Age: 71 YR
• Patient Weight: 77