SCANLAN® SINGLE-USE ELLIPTICAL AORTA/VEIN PUNCH

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR FURTHER ANALYSIS. REVIEW OF THE DESIGN, MANUFACTURING BATCH RECORD, AND TECHNICAL DOCUMENTATION FOUND NO NON-CONFORMITIES. UNABLE TO DRAW A CONCLUSION FROM THE INFORMATION AVAILABLE.

Description of Event or Problem

"DURING A LIVE DONOR KIDNEY TRANSPLANT, THE AORTIC PUNCH DID NOT CUT PROPERLY AND TORE THE ARTERY". AS REPORTED. A YOUNG PATIENT UNDERWENT A KIDNEY TRANSPLANT FROM A LIVING DONOR. DURING THE SURGERY, AN ARTERIOTOMY WAS PERFORMED, AND THE SCANLAN AORTIC PUNCH WAS USED. HOWEVER, THE DEVICE FAILED TO FUNCTION PROPERLY AND BECAME JAMMED, CAUSING SIGNIFICANT DAMAGE TO THE EXTERNAL ILIAC ARTERY. AS A RESULT, RESECTION OF THE DAMAGED ARTERIAL SEGMENT WAS REQUIRED, FOLLOWED BY THE PLACEMENT OF A PTFE VASCULAR GRAFT AND ANASTOMOSIS OF THE KIDNEY GRAFT ONTO THIS PROSTHETIC GRAFT. DESPITE THESE MEASURES, ADEQUATE BLOOD FLOW COULD NOT BE ESTABLISHED, AND A NEPHRECTOMY OF THE TRANSPLANTED KIDNEY WAS NECESSARY.