MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-03-31 for BIOSPHERE EMBOSPHERES S220GH/JPA manufactured by Biosphere Medical Sa.
[71388568]
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.
Patient Sequence No: 1, Text Type: N, H10
[71388569]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2017-00012 |
| MDR Report Key | 6449404 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-13 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY HUGHES, MS, CQE |
| Manufacturer Street | 1600 WEST MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer G1 | BIOSPHERE MEDICAL SA |
| Manufacturer Street | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | 95700 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSPHERE EMBOSPHERES |
| Generic Name | EMBOSPHERES |
| Product Code | NAJ |
| Date Received | 2017-03-31 |
| Catalog Number | S220GH/JPA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL SA |
| Manufacturer Address | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Death | 2017-03-31 |