Phasix Mesh

Description of Event or Problem

As reported per Clinical Trial (b)(4):The subject patient was admitted on (b)(6) 2024 and underwent open primary laparotomy rectum amputation with concomitant procedure of ostomy on (b)(6) 2024 during which a Phasix Flat Mesh was trimmed and placed in an only fashion and secured using slow absorbable monofilament sutures and patient was administered prophylactic antibiotics (Metronidazole and Cefuroxim), prescribed peri-operatively and was discharged on (b)(6) 2024.(b)(6) 2026 - Patient was diagnosed with Ileus (intestinal pseudo-obstruction).No stoma output since 15 July. The patient experienced abdominal pain, and CT showed a large parastomal hernia (clinically assessed as not related to the study device) with incarceration of small bowel loops. Surgery was indicated on 17 July via midline laparotomy.Open Pauli repair (TAR left, retromuscular net-Dynamesh 20x20 cm) Adhesiolysis, suture of serosa, Midline laparotomy.As reported, the adverse event (Ileus) has been assessed per clinician (Medical Monitor) as possibly related to study device and causally related to procedure. The clinician (Site Investigator) has assessed the adverse event (ileus) as not related to the subject device or the procedure. The severity has been assessed as severe. The reported AE does 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, the subject patient was diagnosed with ileus (intestinal pseudo-obstruction) two years post implant of the Phasix Mesh. Ileus is a common complication of the index surgical procedure performed. The clinician (Medical Monitor) has assessed the patient's postoperative outcome of ileus (intestinal pseudo-obstruction) as possibly related to the study device. The clinician (Site Investigator) has assessed the adverse event ileus (intestinal pseudo-obstruction) as not related to the subject device. However, based on the information available, the degree to which the implanted Phasix Flat Mesh may have caused or contributed to the reported ileus cannot be determined. The patient was also being treated for a large parastomal hernia with incarcerated small bowel loops, which was clinically assessed as not related to the study device and may represent a confounding factor in the patient's postoperative course. A review of the manufacturing records was conducted and confirmed that the device was manufactured in accordance with established specifications.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.