An interventional radiologist reported the following incident, post ire/ nanoknife procedure, to an angiodynamics territory manager: "i was called on 05/11/21 by dr.(b)(6) regarding a patient treated on (b)(6) 2021 surgically in the or at uf shands in (b)(6).It is my understanding that the patient received a pancreatic resection, with ire/nanoknife and is enrolled in the registry of the direct trial.On the evening of (b)(6) 2021 dr.(b)(6) called me to notify me that the patient had experience complications due to the surgery and the family had chosen to transition the patient to comfort care or hospice rather than seek additional interventions.Dr.(b)(6) let me know that the patient was still alive but was expected to pass away in the coming days.Dr.Heithaus also stated that the cause of the complication was undetermined.It is not known if it was a complication related to the surgical procedure, resection, or ire portion of the surgery.I spoke with dr.(b)(6) on the morning of (b)(6) 2021 to check on the patient status and he had no update at the time." additional information received on may 13, 2021, reported the patient had not expired as of yet.It was reported by the physician, that the patient complications were related to an infection that had developed a week or more out from surgery, during which time the patient ignored their symptoms.There was no suspicion or allegation that the nanoknife system contributed to or caused the patient issue.It was indicated that the associated device is not available to be returned to the manufacturer for evaluation.
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