MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Inflammation (1932); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Prolapse (2475)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as a best estimate based on the date of the mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).The mesh removal surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y- mesh device was implanted into the patient during a robotic-assisted vaginal hysterectomy, sacrocolpopexy and cystoscopy procedure performed on (b)(6) 2015 for the treatment of uterine prolapse with cystocele.The patient had follow-up visits to the clinic multiple times after her hysterectomy, complaining of vaginal discharge and vaginal bleeding.Reportedly, the patient had granulation tissue present that was biopsied and ablated with silver nitrate multiple times but her symptoms continued.Computerized tomography (ct) scan was performed and ruled out fistula.The patient is requesting an excision of the tissue.On (b)(6) 2021, the patient underwent an exploratory laparoscopy + lysis of adhesions and undermining of sacrocolpopexy mesh + vaginal exploration with excision of vaginal cuff granulation tissue.During the vaginal exam, a small area of vaginal granulation tissue was observed.When this was excised, there was an underlying area of mesh exposed just under the surface.On laparoscopic exam, there was a thick area of peritoneum that was concerning for an area of bowel that was adhered to the vaginal cuff.Reportedly, the mesh was slightly undermined for a better closure with careful attention to maintain suspension of the vaginal cuff.The cuff was then closed with 1-0 vicryl in a running locking suture.Hemostasis was noted.No further invention was necessary.The patient tolerated the procedure well and was transported to the recovery room in stable condition.On (b)(6) 2021, the patient underwent an exploratory laparotomy, lysis of pelvic adhesions, excision of vaginal mesh (22 modifier), open uterosacral vaginal vault suspension, cystourethroscopy and flexible sigmoidoscopy for the treatment of mesh erosion, stage 2 vaginal vault prolapse and pelvic adhesions.During the procedure, a scarred mesh was noted in the midline, extending from sacral promontory to the vaginal cuff.The mesh was noted to be densely adherent to the sigmoid colon and a thickened, inflammatory mass was noted at the vaginal insertion of the mesh.Using bovie electrocautery, the peritoneum overlying the mesh on the right, was incised sharply.This incision was made medial to the right ureter, and the right ureter was reflected laterally.After unsuccessfully attempting to clearly identify the plane between the mesh and the sigmoid colon, to the left of the mesh, the decision was made to transect the mesh at the level of the promontory, and peel it off of the sigmoid colon.Accordingly, with traction to the patient's right, the mesh was carefully transected from the sacral promontory.The mesh was then carefully dissected off of the sigmoid colon.At the vaginal apex, an inflammatory mass was encountered.Upon incising the mass at the vaginal cuff, purulent drainage was identified.The dissection was difficult and somewhat bloody, as the inflammation made the tissues very friable.After approximately 1.5 hours of dissection, the vaginal cuff was encountered and entered sharply.The cuff was transected anteriorly and posteriorly in order to excise the vaginal cuff.A 6cm segment of mesh was excised.Inspection of the vaginal cuff clearly demonstrated erosion of the colpopexy mesh through the mucosa of the vaginal apex.The rectovaginal septum was carefully opened and the posterior arm of the mesh was dissected off of the posterior vaginal wall.A 3x3cm segment of mesh was dissected off of the posterior vagina.Attention was turned to the anterior vaginal wall, where the bladder was dissected off of the anterior leaf of the mesh.The mesh was dissected off of the anterior vaginal wall, and a second 3x3 segment of mesh was identified and excised.Hemostasis was confirmed and the vaginal cuff was closed with interrupted 0-vicryl suture.After very difficult dissection, an intraoperative flexible sigmoidoscopy was performed and bowel integrity was confirmed.Attention was then turned to the vaginal vault suspension portion of the procedure.The ureters were visualized and noted to be away from the operative field.With traction on the vaginal cuff, the uterosacral ligaments were grasped at the level of the mid-uterosacral ligament.Prolene sutures were placed at the level of the mid-ligament, and reefed medially on the ligament and secured through the vaginal cuff.This procedure was performed on the patient's right, followed by the patient's left.Care was taken to avoid impinging on the rectum.No bladder or urethral injuries or lesions were identified.The peritoneum was closed with 0-vicryl suture, the fascia was closed with 0- vicryl suture, the subcutaneous tissues were closed with 0-vicryl sutures and the skin was closed with 3-0 monocryl suture.Dressings were applied and the patient was awakened and taken to the recovery room in stable condition.

• Brand Name: UPSYLON
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13967055
• MDR Text Key: 288304539
• Report Number: 3005099803-2022-01576
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female