MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03,05 report with the FDA on 2009-05-01 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRE manufactured by Genzyme Polyclonals S.a.s..
[1128789]
Hepatic artery thrombosis (hepatic artery thrombosis). Biliary duct necrosis (bile duct necrosis). Hepatic artery thrombosis (hepatic artery thrombosis). Liver graft loss (liver graft loss). Case description: report received on 06 march 2009 from an unpublished literature report. This is a literature report entitled, "celsior preservation fluid in liver transplantation: results of a prospective, multicenter study. Grandadam s et al. " the literature describes a one-year, prospective, center, study to assess the results from a total pts who received donor livers for which recovery was performed using celsior solution. Data compared liver allograft outcomes following graft recovery with celsior preservation fluids. The article describes some pts access nine transplant centers in france that experienced adverse events with celsior. The male liver transplant pt received a liver transplant in 2003. The pt's medical history was significant for biliary duct necrosis. On the following month, 23 days after celsior exposure, the pt experienced hepatic artery thrombosis and biliary duct necrosis. Donor recovery was performed by the conventional technique. Donor livers were perfused in situ by gravity with celsior solution at 4 degrees c. When only aortic annulation was used, 4l celsior solution was rapidly perfused through the aorta at the beginning of the procedure. Where both aortic and mesenteric vein cannulation were used, 2 l was perfused through each route. A further 1l was perfused slowly during the recovery procedure. The biliary tract was rinsed ex situ with an additional 100ml. During storage, the liver was completely immersed in at least 1l solution and maintained at 4 degrees c until transplantation. Transplantation was performed by the piggyback technique i. E. Preserving the retrohepatic vena cava. Portal, arterial, and biliary anastomoses were performed according to the local expertise of each center. Immediately prior to revascularization, the liver was washed with 500 ml of 4% human albumin solution at 4 degrees c via the portal vein. The rewarming period was defined as the time which elapsed between portal vein declamping and arterial declamping. Three months later, the pt experienced hepatic artery thrombosis for a second time. On an unspecified date, the pt experienced graft loss due hepatic artery thrombosis. In early 2004, the pt received a second liver transplant due to the graft loss. The pt's outcome and the intensity of the events were not provided. Concomitant medications at the time of the events included ciclosporine, mycophenolate mofetil, and prednisone (dosing regimens not provided). It was the opinion of the authors that the events were possible related to celsior.
Patient Sequence No: 1, Text Type: D, B5
[8459333]
Manufacturer's comment: the accompanying unpublished literature article summarizes the results of a celsior study conducted by a group of investigators independent of genzyme. Upon request, the authors of the literature article provided a tabular listing of celsior adverse events that provided individual pt identifiers. Seven of the cases described had previously been reported to genzyme during the course of the study. The authors concluded that this prospective, multicenter study suggests that liver preservation with celsior is efficient and safe. The benefit-risk relationship of celsior is not affected by this report. Journal: unpublished literature. Author: grandadam et al. Title: celsior preservation fluid i liver transplantation: results of a prospective, multicenter study.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2009-00001 |
| MDR Report Key | 1374457 |
| Report Source | 01,02,03,05 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-03-06 |
| Date of Event | 2003-02-14 |
| Date Mfgr Received | 2009-03-06 |
| Date Added to Maude | 2009-05-11 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WYTSKE KINGMA, MD |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 8007454447 |
| Manufacturer G1 | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Street | 58 AVENUE DEBOURG |
| Manufacturer City | LYON |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRE |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2009-05-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-05-01 |