MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES

Model Number S220, 420, 620GH

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Infarction, Cerebral (1771)

Event Date 01/19/2015

Event Type  Injury  

Event Description

Primary disease: right chest wall tumor (pathological diagnosis: possible solitary fibrous tumor).Vascular embolization was performed preoperatively for right chest wall tumor to reduce the amount of bleeding during surgery, as the tumor was huge and sanguineous.Before embolization, pentagin was administered for pain in the trunk.At this point, patient had a number of unidentified complaints and was awake and alert.Just when the procedure was almost finished, decreased blood pressure, tachycardia and increased electrocardiographic t wave amplitude developed.Decreased consciousness was noted at this point.Blood gas test, 12-lead electroradiography, ct of the trunk and mri of the head were performed.Ct of the trunk showed tumor growth and mri of the head showed multiple infractions bilaterally.Embosphere (probably the 100-300um) was considered likely to have spread systemically via an arterio-venous shunt or arterio-arterial shunt inside the tumor, leading to cerebral infarction.

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.(b)(4) medical/biosphere medical will continue to pay attention to the development of similar events.(b)(4) medical/biosphere medical will continue to pay attention to the development of similar events.

• Brand Name: EMBOSPHERE MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; roissy-en-france ; FR
• Manufacturer Contact: alix fonlladosa ; bat.a.parc de nations, paris; nord 2 383 rue de la belle; etolle rossy ch de gaulle cede ; FR ; 4817252
• MDR Report Key: 4808037
• MDR Text Key: 5831995
• Report Number: 9615728-2015-00007
• 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,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S220, 420, 620GH
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 53 YR
• Patient Weight: 37