SERAPH 100

Additional Manufacturer Narrative

THE ADVERSE EVENT WAS DETERMINED TO BE RELATED TO THE SURGERY BEING PERFORMED ON THE PATIENT. BLOOD FLOW INTERRUPTION IS A KNOWN POSSIBLE SIDE EFFECT OF VASCULAR GRAFT EXCISION PROCEDURES DUE TO THE PROLONGED AORTIC CLAMPING REQUIRED. THERE IS NO KNOWN MECHANISM LINKING USE OF THE SERAPH 100 DEVICE TO THIS ADVERSE EVENT.

Description of Event or Problem

AS PRESENTED IN AN ARTICLE TITLED "INTRAOPERATIVE EXTRACORPOREAL BLOOD PURIFICATION THERAPY DURING MAJOR SEPTIC VASCULAR SURGERY" A PATIENT [AGE 61, CO-MORBIDITIES OF DENUTRITION, HYPERTENSION, SOLID TUMOR, AND OBLITERATING ARTERIOPATHY OF THE LOWER LIMBS (OALL)] HAD A POST-OPERATIVE COMPLICATION OF MESENTERIC ISCHEMIA. [NOTE: SURGERY WAS PERFORMED SOMETIME BETWEEN DECEMBER 2021 AND MAY 2022.] PATIENT WAS RECEIVING INTRAOPERATIVE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND SERAPH 100 TREATMENT DURING A GRAFT REMOVAL WITH CRYOPRESERVED ARTERIAL ALLOGRAFT (CAA) RECONSTRUCTION. BROAD-SPECTRUM ANTIMICROBIAL THERAPY APPLIED PREOPERATIVELY. CITRATE WAS ADMINISTERED AS AN ANTICOAGULANT. DIALYSATE COMPOSITION, CITRATE AND CALCIUM REPLACEMENT WERE ADJUSTED DURING SURGERY. PATIENT PREVIOUSLY HAD AN AORTO-BIFEMORAL GRAFT; PRE-OPERATION, THE PATIENT HAD A GROIN INFECTION AND WAS BEING TREATED BY DRAINAGE AND NEGATIVE-PRESSURE WOUND THERAPY. GRAFT REMOVAL WITH CAA RECONSTRUCTION SURGERY LASTED 381 MINUTES AND AORTIC CLAMPING DURATION WAS 101 MINUTES. MESENTERIC ISCHEMIA PRESENTED 6 DAYS POST-OPERATION AND REQUIRED A SECONDARY SURGERY TO TREAT. ARTICLE HIGHLIGHTS THE MESENTERIC ISCHEMIA EXPERIENCED BY THE PATIENT AS AN EXTRACORPOREAL BLOOD PURIFICATION (EBP) THERAPY-RELATED ADVERSE EVENT.