MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502000

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Ischemia (1942); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Constipation (3274)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e0509 - captures the reportable event of ischemia.E2328 - captures the reportable event of bowel obstruction.E2101 - captures the reportable event of adhesions.E1002 - captures the reportable event of abdominal pain.The following imdrf impact codes capture the reportable event of: f2203 - captures the reportable event of the patient who had to undergo computed tomography (ct) scan.

Event Description

It was reported to boston scientific corporation that an advantage system and a non-boston scientific y-mesh system devices were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient experienced chronic constipation.She had a history of multiple pelvic surgeries and presented with symptoms of nausea, vomiting, and abdominal pain, and computed tomography (ct) imaging revealed concerns of small bowel obstruction versus constipation.Non-operative management did not work, and the patient continued to have signs and symptoms of obstruction.As a result, on december 1, 2022, the patient underwent a lysis of adhesions, exploratory laparotomy, and small bowel resection procedure.During the procedure, the surgeon observed that the distal part of the small intestine was adhered in the pelvis and the small bowel proximal to it was significantly enlarged.As the adhesion could not be accessed laparoscopically, the surgeon decided to convert to an open approach.Additionally, the distal small bowel was found to be entrapped under the mesh that extended from the patient's vaginal cuff to her sacral promontory.It was observed that the small bowel proximal to the adhesion was ischemic.Consequently, around 20 cm of small bowel was removed using a gastrointestinal (gia) stapler.The mesentery was taken down using clamps and silk ties, and a side-to-side stapled anastomosis was completed.The surgeon grasped and cut one corner of each staple line of the proximal and distal limbs of the small bowel.The blue and white interlocking halves of the stapler were placed in each hole, and the anastomosis was created with a blue load.The surgeon confirmed intraluminal hemostasis after the procedure.The remaining hole was then closed using babcock and allis clamps.The blue stapler was used to seal the defect, ensuring that the serosa and mucosa were entirely within the stapler.The staple line was evaluated, and hemostasis was confirmed.The antimesenteric borders of the anastomosis were approximated using a 2-0 silk suture.The bowel was then returned to the peritoneal cavity.The rest of the small bowel was examined from the ligament of treitz to the cecum and found to be normal.The patient was extubated without complications and was taken to the post-anesthetic unit in stable condition.

• Brand Name: ADVANTAGE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18613814
• MDR Text Key: 334207683
• Report Number: 2124215-2024-04550
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0000044727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• 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: 68 YR
• Patient Sex: Female