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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
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.
 
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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 Key18613814
MDR Text Key334207683
Report Number2124215-2024-04550
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729470274
UDI-Public08714729470274
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020110
Number of Events Reported1
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 Date10/04/2019
Device Model NumberM0068502000
Device Catalogue Number850-200
Device Lot Number0000044727
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2024
Initial Date FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexFemale
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