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

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572)

Event Date 06/01/2009

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009, was chosen as a best estimate based on the month and year 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 d6a, d6b: the exact implant date is unknown.The provided implant date of (b)(6) 2009, was chosen as a best estimate based on the month and year of the mesh was implanted.The exact explant date is unknown.The provided explant date of (b)(6) 2022 was chosen as a best estimate based on the month and year of the mesh was explanted.Block e1: this event was reported by the patient's legal representation.The implanting facility is: (b)(6).The explanting facility is: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2330 - has been used to capture the reported event of pelvic pain.E1310 - has been used to capture the reported event of recurrent urinary tract infection.E2006 - has been used to capture the reported event of vaginal mesh was found eroded.E230901 - has been used to capture the reported event of vaginal mesh was found eroded and calcified.E0206 - has been used to capture the reported event of the patient has experienced significant mental pain and suffering.The following imdrf impact codes capture the reportable event of: f23 - has been used to capture the reported event of patient has undergone medical treatment and will likely undergo further medical treatment.F1202 - has been used to capture the reported event of patient has sustained permanent injury.F1903 - has been used to capture the reported event of vaginal mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed in (b)(6) 2009 for the treatment of uterine prolapse and stress urinary incontinence.After the device was implanted, the patient began to experience severe complications related to the implant, including but not limited to urinary incontinence, recurrent urinary tract infections, urinary frequency, pelvic pain, and overactive bladder, among other complications.On or around (b)(6) 2022, the patient underwent vaginal mesh removal, where the vaginal mesh was found eroded and calcified.In addition, the patient has experienced significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, lost income, and other damages.

Manufacturer Narrative

Block h2: additional information the implanting physician is: (b)(6).Correction: block d7a (sud reprocessed and reused?) has been corrected from no information to no.Block b3 date of event: the exact event onset date is unknown.The provided event date of june 1, 2009, was chosen as a best estimate based on the month and year 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 d6a, d6b: the exact implant date is unknown.The provided implant date of (b)(6) 2009, was chosen as a best estimate based on the month and year of the mesh was implanted.The exact explant date is unknown.The provided explant date of (b)(6) 2022 was chosen as a best estimate based on the month and year of the mesh was explanted.Block e1: this event was reported by the patient's legal representation.The implanting facility is: (b)(6).The explanting facility is: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2330 - has been used to capture the reported event of pelvic pain.E1310 - has been used to capture the reported event of recurrent urinary tract infection.E2006 - has been used to capture the reported event of vaginal mesh was found eroded.E230901 - has been used to capture the reported event of vaginal mesh was found eroded and calcified.E0206 - has been used to capture the reported event of the patient has experienced significant mental pain and suffering.The following imdrf impact codes capture the reportable event of: f23 - has been used to capture the reported event of patient has undergone medical treatment and will likely undergo further medical treatment.F1202 - has been used to capture the reported event of patient has sustained permanent injury.F1903 - has been used to capture the reported event of vaginal mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed in (b)(6) 2009 for the treatment of uterine prolapse and stress urinary incontinence.After the device was implanted, the patient began to experience severe complications related to the implant, including but not limited to urinary incontinence, recurrent urinary tract infections, urinary frequency, pelvic pain, and overactive bladder, among other complications.On or around (b)(6) 2022, the patient underwent vaginal mesh removal, where the vaginal mesh was found eroded and calcified.In addition, the patient has experienced significant mental and physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, and has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, lost income, and other damages.

• 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 ; 5086834015
• MDR Report Key: 17996335
• MDR Text Key: 326390040
• Report Number: 3005099803-2023-05720
• 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,Followup
• Report Date: 12/28/2023

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• 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