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

Device Problem Material Integrity Problem (2978)

Patient Problems Capsular Contracture (1761); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Obstruction/Occlusion (2422); Fibrosis (3167); Insufficient Information (4580)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of november 18, 2021, was chosen as a best estimate based on the date of the mesh was implanted.Block d4, h4: the complainant was unable to provide the suspect lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2313 - captures the reportable event of significant bridging fibrosis.E2311 - captures the reportable event of discomfort.E1715 - captures the reportable event of scar plating.E2330 - captures the reportable event of extreme pain.E1309 - captures the reportable event of urinary retention.E2401 - captures the reportable event of unspecified injuries.E2328 - captures the reportable event of urethral obstruction.E2303 - captures the reportable event of encasement in a dense process of scar plating.The following imdrf impact codes capture the reportable event of: f1901 - captures the reportable event of sling excision.F1202 - captures the reportable event of disability.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2021, for the treatment of stress urinary incontinence.After the procedure, the patient reported several injuries, including extreme pain, discomfort, and the inability to empty her bladder.A physician confirmed that the sling used during the procedure was responsible for the urethral obstruction.As a result, the patient underwent another surgery on (b)(6) 2022, during which it was discovered that the sling had shrunk by at least 20 percent since being implanted four months prior.The sling was then removed due to its encasement in a dense process of scar plating with significant bridging fibrosis and a decrease in pore size.The obtryx sling was measured in situ and found to be 0.5 cm in width.Additionally, the patient is experiencing pain from the previous surgery as well as injuries from the obtryx procedure.As a result, the patient is currently unable to carry out normal activities, including household duties and hobbies.

• Brand Name: OBTRYX 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: 18712425
• MDR Text Key: 335479160
• Report Number: 2124215-2024-08347
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 01/18/2024
• 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 Sex: Female