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

Device Problem Material Integrity Problem (2978)

Patient Problems Erosion (1750); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage sling system device was implanted during a procedure performed on (b)(6) 2018, for the treatment of pelvic organ prolapse and stress urinary incontinence.After the implantation, the patient alleged experiencing severe and debilitating pain, mesh erosion, and exposure/extrusion/protrusion.It was indicated the patient had a defective device.The patient has sustained and will continue to sustain mental and physical pain and suffering, permanent disability, serious bodily injury and harm including a revision surgery of the boston pelvic sling products on (b)(6) 2021.Additionally, the patient has incurred in economic loss and continues to receive medical treatment.The patient may need additional surgeries to remove more mesh.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2021, was chosen as the best estimate based on the revision date.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2006 captures the reportable event of erosion and extrusion.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2401 captures the reportable event of serious bodily injury and harm.Imdrf patient code e0206 captures the reportable event of mental and physical pain and suffering.Imdrf impact code f1202 captures the reportable event of disability.Imdrf impact code f1905 captures the reportable event of revision surgery.Imdrf patient code f2303 captures the reportable event of medical treatment and further surgeries.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17996492
• MDR Text Key: 326391759
• Report Number: 3005099803-2023-05604
• Device Sequence Number: 1
• Product Code: OTN
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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: 09/26/2023
• 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): Disability; Required Intervention
• Patient Sex: Female