PHASIX MESH

Description of Event or Problem

AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6) 2025 THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH DISTAL PANCREATECTOMY, SPLENECTOMY SPLENIC ARTERY LYMPHADENECTOMY, OMENTAL FLAP, LIVER WEDGE BIOPSY AS CONCOMITANT PROCEDURES, DURING WHICH THE PATIENT WAS IMPLANTED WITH PHASIX MESH USING 3-0 PDS ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES USING RUNNING STITCH. SUBJECT PATIENT HAD A PANCREATIC LEAK FROM POD 3 DRAIN AMYLASE AND WAS SENT HOME ON (B)(6) 2025 WITH JPS TO REMOVE LATER. ON (B)(6) 2025 THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 WITH FEVER AND UNDERWENT CT IMAGING. IT WAS NOTED THE LUQ DRAIN SITE HAD REDNESS & PURULENT DRAINAGE. ON (B)(6) 2025 THE PATIENT UNDERWENT A CT SCAN SHOWING SOFT TISSUE STRANDING THROUGHOUT THE RIGHT FLANK ENCOMPASSING THE LEFT DRAIN, WHICH MAY REFLECT DEVELOPING CELLULITIS. REDNESS HAD GROWN ON SUBJECT'S SIDE. THE SUBJECT PATIENT'S PAIN WAS MANAGED WITH PO AND IV MEDICATION. AS REPORTED, "ALTHOUGH THE PANCREATIC LEAK IS THE PRIMARY CAUSE OF THE ACUTE ABDOMINAL PAIN IN THIS PATIENT, THE CONTRIBUTORY ROLE OF THE STUDY DEVICE TO THE EVENT IS POSSIBLE BASED AVAILABLE INFORMATION." AS REPORTED, THE ADVERSE EVENT (ACUTE ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT). ADDENDUM: AS REPORTED, THE ADVERSE EVENT (ACUTE ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS NOT RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED ACUTE ABDOMINAL PAIN FOLLOWING A COMPLEX PROCEDURE DURING WHICH A PHASIX MESH HAD BEEN IMPLANTED. AS REPORTED THE "PANCREATIC LEAK IS THE PRIMARY CAUSE OF THE ACUTE ABDOMINAL PAIN IN THIS PATIENT, THE CONTRIBUTORY ROLE OF THE STUDY DEVICE TO THE EVENT IS POSSIBLE." THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME OF ACUTE ABDOMINAL PAIN AS POSSIBLY RELATED TO THE STUDY DEVICE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT THAT THE AE WAS CLINICALLY RE-EVALUATED AS NOT RELATED TO THE STUDY DEVICE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED ACUTE ABDOMINAL PAIN FOLLOWING A COMPLEX PROCEDURE DURING WHICH A PHASIX MESH HAD BEEN IMPLANTED. AS REPORTED THE "PANCREATIC LEAK IS THE PRIMARY CAUSE OF THE ACUTE ABDOMINAL PAIN IN THIS PATIENT, THE CONTRIBUTORY ROLE OF THE STUDY DEVICE TO THE EVENT IS POSSIBLE." THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME OF ACUTE ABDOMINAL PAIN AS POSSIBLY RELATED TO THE STUDY DEVICE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6) 2025, THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH DISTAL PANCREATECTOMY, SPLENECTOMY SPLENIC ARTERY LYMPHADENECTOMY, OMENTAL FLAP, LIVER WEDGE BIOPSY AS CONCOMITANT PROCEDURES, DURING WHICH THE PATIENT WAS IMPLANTED WITH PHASIX MESH USING 3-0 PDS ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES USING RUNNING STITCH. SUBJECT PATIENT HAD A PANCREATIC LEAK FROM POD 3 DRAIN AMYLASE AND WAS SENT HOME ON (B)(6) 2025 WITH JPS TO REMOVE LATER. ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 WITH FEVER AND UNDERWENT CT IMAGING. IT WAS NOTED THE LUQ DRAIN SITE HAD REDNESS & PURULENT DRAINAGE. ON (B)(6) 2025, THE PATIENT UNDERWENT A CT SCAN SHOWING SOFT TISSUE STRANDING THROUGHOUT THE RIGHT FLANK ENCOMPASSING THE LEFT DRAIN, WHICH MAY REFLECT DEVELOPING CELLULITIS. REDNESS HAD GROWN ON SUBJECT'S SIDE. THE SUBJECT PATIENT'S PAIN WAS MANAGED WITH PO AND IV MEDICATION. AS REPORTED, "ALTHOUGH THE PANCREATIC LEAK IS THE PRIMARY CAUSE OF THE ACUTE ABDOMINAL PAIN IN THIS PATIENT, THE CONTRIBUTORY ROLE OF THE STUDY DEVICE TO THE EVENT IS POSSIBLE BASED AVAILABLE INFORMATION." AS REPORTED, THE ADVERSE EVENT (ACUTE ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).