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 OF ORGAN PRESERVATION manufactured by Genzyme Polyclonals S.a.s..
[1156158]
Acute thrombosis of the hepatic arterial axis [hepatic artery thrombosis]. Ischemic cholangitis of biliary duct [cholangitis]. Case description: report received on 06 march 2009 from an unpublished literature report.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 patients across transplant centers in other country, that experienced adverse events with celsior. The male liver transplant patient received a liver transplant in 2002. The pt's medical history was not provided. On the following month, 19 days after celsior exposure, the pt experienced acute thrombosis of the hepatic arterial axis. 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. The pt's in situ thrombosis led to in situ vasodilatation. The pt was treated with radiologic stent placement on the hepatic artery. In late 2002,100 days after the transplantation, the pt experienced ischemic cholangitis of the biliary duct with febrile icterus. Retrograde catheterization of papilla duodeni and biliary duct prosthesis placement were performed. The pt's outcome and the intensity of the events were not provided. Concomitant medications at the time of the events included tacrolimus, prednisone, sulfamethoxazole, trimethoprime, zopiclone, and corticosteroids. It was the opinion of the authors that acute hepatic artery thrombosis was possibly related to celsior and ischemic cholangitis was unrelated to celsior, and related to the hepatic artery thrombosis.
Patient Sequence No: 1, Text Type: D, B5
[8391010]
Mfr'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 in liver transplantation: results of a prospective, multicenter study.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2009-00002 |
| MDR Report Key | 1374456 |
| Report Source | 01,02,03,05 |
| Date Received | 2009-05-01 |
| Date of Report | 2009-03-06 |
| Date of Event | 2002-09-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | WYTSKE KINGMA, MD |
| Manufacturer Street | 675 WEST KENDALL ST |
| 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 OF ORGAN PRESERVATION |
| 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 | 2009-05-01 |