MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Thrombosis (2100)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Title use of imlifidase (ides) in renal transplantation for high strength donor specific antibody/positive crossmatch: uk¿s 1st case source abstracts of the 19th congress of the european society for organ transplantation, volume 32(suppl.2), 2019 (403¿433).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, a success rate of vancomycin: according to literature source of study describing the use of imlifidase (ides) in renal transplantation.The study states that ides generated a potential window to facilitate a transplant avoiding hyperacute rejection.Management of rebounding dsa (donor specific antibody) was a major obstacle.The patient underwent transplant in lif (left iliac fossa) over a permcath, which was placed 1 week prior, with plasty to the left civ (common iliac vein) and ivc (inferior venca cava), to facilitate (pex) planned plasma exchange.A clot in eiv (external iliac vein) around the permcath had to be dealt with at time of transplant.Patient developed immediate primary function with reduction of scr (selective catalytic reduction) from 495 to 321.Day 2 post op, urine output tailed off.The kidney remained perfused on "uss".The dsa rebounded and the patient developed tma (thrombotic microangiopathy).Patient was immediately commenced on standard therapies for "amr" (ivig intravenous immunoglobulin, pex, rituximab).As dsa titres continued to rise, eculizumab therapy was commenced on day 5.Patient underwent splenectomy on day 10 as dsa continued to rise.On day 14 uss showed poor perfusion and biopsy confirmed amr.Patient underwent transplant nephrectomy on day 15.There was no reported patient outcome.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10544029
• MDR Text Key: 207325544
• Report Number: 3009211636-2020-00226
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• 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): Required Intervention