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

Model Number M0068502120

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 01/22/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit blue system device was implanted into the patient during a procedure performed on (b)(6) 2020, for the treatment of stress urinary incontinence and vaginal prolapse.On (b)(6) 2020, the patient was seen post-surgically and noted to have mixed urinary incontinence.The patient reported stress urinary incontinence with coughing, straining, and laughing, and having to wear one pad per day.Although the noted urge urinary incontinence was better, the patient reported nocturnal enuresis happening at least 3 times in the three weeks prior to the appointment.The patient underwent a cystourethroscopy on (b)(6) 2023, to rule out any possibility of mesh exposure to her lower urinary tract.The patient also alleged dyspareunia.On (b)(6) 2023, the patient was seen for consultation on mesh exposure.During the manual examination, vaginal depth and caliber were adequate, allowing two fingers.There was firmness and induration palpable along the anterior vaginal wall, with the foreign mesh being palpable in the left anterior vaginal sulcus.On (b)(6) 2023, the patient underwent a transvaginal mesh resection and the excision of polypropylene mesh from the vaginal lumen.The patient was examined under anesthesia, with findings demonstrating a 2 cm segment of the polypropylene mesh bridging the left lateral sulcus distal third of the vagina.During the procedure, the surgeon was able to identify the polypropylene mesh essentially bridging the left vaginal sulcus.The surgeon was able to get a right-angle clamp behind the mesh and, with downward traction, visualize both its entry site laterally and its origin medially.A small vaginal incision was made to slightly core the mesh out laterally to a point that could come across it easily deep within the fibromuscular layer of the vagina.During the transection of the sling, the lateral edge retracted significantly and was not long visible or palpable.Traction was continued medially; the adherent fibromuscular tissue was resected from the mesh.The mesh was then transected deep into the vaginal epithelium and the segment was retrieved and sent for gross observation.To date, the patient still experienced urinary issues, a painful bladder, a feeling of fullness, difficulties with urinary incontinence, and dyspareunia.The patient also noted permanent injury and significant mantal, and physician pain and suffering.The patient noted serious bodily injuries, extreme pain, discomfort, urinary problems, dyspareunia, and other injuries related to the mesh device.These injuries will result in some permanent disability for the patient.Additionally, the patient has incurred in economic loss and will continue to incur in expenses related to medical treatment.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2020, was chosen as the best estimate based on the implant date.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e232402 captures the reportable event of urinary problems.Imdrf patient code e2006 captures the reportable event of mesh exposure.Imdrf patient code e1309 captures the reportable event of feeling of fullness.Imdrf patient code e0206 captures the reportable event of significant mental and physical pain and suffering.Imdrf patient code e1311 captures the reportable event of urinary issues.Imdrf patient code e2101 captures the reportable event of adherent fibromuscular tissue was resected from the mesh.Imdrf impact code f1202 captures the reportable event of disability.Imdrf impact code f1905 captures the reportable event of excision of polypropylene mesh.

• Brand Name: ADVANTAGE FIT BLUE 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18204593
• MDR Text Key: 328910067
• Report Number: 2124215-2023-65738
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Female