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

Model Number DIALYSIS UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/01/2019

Event Type  malfunction  

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 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 ussshowed poor perfusion and biopsy confirmed amr.Patient underwent transplant nephrectomy on day 15.There was no reported patient outcome.

Event Description

Pli 10: 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 (anitibody mediated rejection).Patient underwent transplant nephrectomy on day 15.There was no reported patient outcome.

Manufacturer Narrative

Additional information: b5, g4, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 10544033
• MDR Text Key: 207326355
• Report Number: 3009211636-2020-00227
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention