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

Catalog Number S220GH

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It has been reported that a patient with hepatocellular carcinoma (stage iii) developed an acute pancreatitis immediately after trans arterial embolisation (tae) performed near to the gastroduodenal artery with the device (embosphere microspheres).On the same day, the patient was placed on nil per os status in consideration of the risk of ischemic pancreatitis developing as a complication, since a small amount of embosphere seemed to have flown back.Epigastric pain developed soon after treatment.The patient also had strong queasiness and vomiting.The symptoms exacerbated and bth pancreatic amylase and lipase levels increased.Then the symptoms improved after futhan (nafamostat mesilate) administration and fasting.On (b)(6), patient started oral intake.On (b)(6) patient was discharged from the hospital.

Manufacturer Narrative

Nothing is expected to be returned for evaluation.Since the lot number was not provided, the device history record and complaint database could not be reviewed for similar issues.The instructions for use provide a warning to pay careful attention for signs of mis-targeted embolization.During injection, it is required to carefully monitor patient vital signs to include sao2 (e.G.Hypoxia, en changes).And consider terminating the procedure, investigating for possible shunting, or increasing microsphere size if any signs of mis-targeting occur or patient symptoms develop.Merit is unable to determine a root cause.

• 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 de nations, paris nord 2; 383, rue de la belle etoie; roissy en france ; FR ; 48172529
• MDR Report Key: 4336126
• MDR Text Key: 15344063
• Report Number: 9615728-2014-00003
• 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: S220GH
• 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): Hospitalization; Other
• Patient Age: 64 YR
• Patient Weight: 53