Phasix Mesh

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026 THE SUBJECT PATIENT UNDERWENT OPEN PRIMARY LAPAROTOMY AORTO-ILIAC OCCLUSION PROCEDURE DURING WHICH A PHASIX FLAT MESH WAS TRIMMED AND PLACED IN AN ONLAY FASHION AND WAS SECURED USING NON-ABSORBABLE MONOFILAMENT PERMANENT SUTURES. PATIENT WAS PRESCRIBED WITH CEFAZOLIN AND DISCHARGED ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED AN ABDOMINAL RUPTURE OR HERNIA. ON (B)(6) 2026 THE PHASIX MESH WAS REMOVED COMPLETELY. THE REPORTED ADVERSE EVENT (ABDOMINAL RUPTURE OR HERNIA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE, HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERING/RESOLVING. THE SEVERITY HAS BEEN ASSESSED AS MODERATE. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, POST IMPLANT OF THE PHASIX MESH AS AN ONLAY, THE SUBJECT PATIENT EXPERIENCED AN ABDOMINAL RUPTURE/HERNIA AND SUBSEQUENTLY UNDERWENT MESH REMOVAL. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE ABDOMINAL RUPTURE/HERNIA AS POSSIBLY RELATED TO THE STUDY DEVICE. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EXTENT TO WHICH THE PHASIX FLAT MESH IMPLANT USED TO TREAT THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S POSTOPERATIVE ABDOMINAL RUPTURE/HERNIA CANNOT BE DETERMINED. HENCE, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS OR TO PREVENT OCCURRENCES WHEN REINFORCING SURGICAL INCISIONS PROPHYLACTICALLY, THE MESH SHOULD BE SIZED WITH APPROPRIATE OVERLAP FOR THE SIZE AND LOCATION OF THE DEFECT OR SURGICAL INCISION, TAKING INTO CONSIDERATION ANY ADDITIONAL CLINICAL FACTORS APPLICABLE TO THE PATIENT. CAREFUL ATTENTION TO MESH FIXATION PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR GAP FORMATION BETWEEN THE MESH AND FASCIAL TISSUE." 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.