Ventralight ST Mesh

Description of Event or Problem

Per information provided:(b)(6)2013 - Patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of Ventralight ST Mesh (Device 2). Per op notes, "A lower midline incision from previous surgery was opened. Two discrete fascial defects were noted, one just below the level of the umbilicus, and a second sizable defect which was extended down to cephalad to the pubic symphysis. A Ventralight ST Mesh (Device 2) was placed and secured to the abdominal wall between the sutures with SorbaFix tacker."(b)(6)2017 - Patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of Ventralight ST Mesh (Device 2) and implant of Bard Soft Mesh (Device 3). Per op notes, "A previous lower midline incision was opened from the umbilicus. The Ventralight ST Mesh (Device 2) was noted to be well incorporated and displaced through a wide gap between rectus muscles in the lower midline. Omentum and small bowel were adherent to the deep surface of the mesh (Device 1) and adhesiolysis was performed. The Ventralight ST Mesh (Device 2) was dissected and excised. A Bard Soft Mesh (Device 3) was placed into the wound and secured with sutures."Note: There is no operative notes/information provided regarding Ventralight ST Mesh (Device 1) implanted procedure which is performed on (b)(6)2007.

Additional Manufacturer Narrative

Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course. Note, the manufacturing date (15-Sep-2013) is considered to be a best estimate.This eMDR represents the Ventralight ST Mesh (Device 2). An additional supplemental eMDR was submitted to represent the Ventralight ST Mesh (Device 1). 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.