MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA BIOSPHERE EMBOSPHERES

Catalog Number S220GH/JPA

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

Patient Problems Abscess (1690); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Ventilator Dependent (2395); Cancer (3262)

Event Date 08/23/2016

Event Type  Death  

Manufacturer Narrative

The suspect device will not be returned for evaluation since it is a permanent implant which cannot be recalled.A search of the complaint database and device history record could not be performed because the lot number was not provided.

Event Description

The distributor reported that an elderly man was treated via trans arterial chemoembolization (tace) using an intravenous injection of cisplatin followed by embolization with embosphere on (b)(6) 2016.Immediately after the infusion of embosphere, a vascular lake appeared inside the tumor.On (b)(6), 2016 pyrexia did not improve, liver disorder persisted, and dyspnea developed.Septic shock due to infection after tace and dic were suspected.The patient was transferred to another hospital, and the general condition of the patient was managed in the intensive care unit from (b)(6) 2016.Liver abscess drainage and antibiotic therapy were performed.On (b)(6) 2016 pyrexia developed, and increased c-reactive protein levels were noted.A switch to meropenem hydrate at 3 g/day was thus made.On (b)(6) 2016 pneumonia developed.Sputum culture yielded positive results for (b)(6), and administration of vancomycin hydrochloride was thus initiated.On (b)(6) 2016 enlarged liver abscess in segment 8 was noted and a drainage tube was placed.On (b)(6) 2016 increased pleural effusion was noted, and left pleural fluid was drained.On (b)(6) 2016 worsening respiratory status was noted.On (b)(6) 2016 liver abscess in segment 7 was confirmed to have shrunk and the drainage tube was removed.An additional drainage tube was placed for liver abscess in segment 8.On (b)(6) 2016 the patient was hospitalized again.The patient died on an unknown day in (b)(6) 2017.The distributor stated that investigational results revealed that worsening of the primary disease and a persistent tumor-associated infection resulted in the patient's death.

• Brand Name: BIOSPHERE EMBOSPHERES
• Type of Device: EMBOSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6449404
• MDR Text Key: 71388568
• Report Number: 9615728-2017-00012
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S220GH/JPA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2017
• 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: 3F SHEATH; CISPLATIN, IA, 50MG; GELPART; MEDIKIT RH CATHETER; MEROPENEM HYDRATE 3G/DAY; NEO CERISIER SS; PIPERACILLIN; TAZOBACTAM
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 59