PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 AND UNDERWENT OPEN WHIPPLE RELAPAROTOMY ON (B)(6) 2025 DURING WHICH A PHASIX FLAT MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MONOFILAMENT SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. ON (B)(6) 2025 PATIENT WAS DIAGNOSED WITH A PERIPANCREATIC FLUID COLLECTION. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (PERIPANCREATIC FLUID COLLECTION) HAS BEEN ASSESSED PER CLINICIANS AS NOT RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, AND IT HAS RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED PERIPANCREATIC FLUID COLLECTION (SEROMA) POST IMPLANT OF A PHASIX MESH PLACED IN AN ONLAY FASHION. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS NOT RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. SEROMA FORMATION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. 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.