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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Urinary Retention (2119); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Urinary Incontinence (4572)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, 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 e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e1310 captures the reportable event of recurrent urinary tract infection.Imdrf patient code e1304 captures the reportable event of urge incontinence.Imdrf patient code e2328 captures the reportable event of obstruction from prior sub urethral sling.Imdrf patient code e1906 captures the reportable event of pan cystitis cystica.Imdrf patient code e0506 captures the reportable event of fulminant bleeding encountered during procedure.Imdrf impact code f2203 captures the reportable event of cystoscopy procedure.Imdrf impact code f1905 captures the reportable event of transvaginal sub urethral sling release.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted during a transvaginal mesh mid-urethral tape sling repair procedure performed on (b)(6) 2013, for the treatment of stress urinary incontinence.On (b)(6) 2022, the patient underwent cystoscopy, transvaginal sub urethral sling release, and fulguration of extensive pan cystitis.It was alleged that within 6 months of the implant procedure, the patient developed urge incontinence.In the present, the patient had symptoms of worsening urge incontinence, chronic retention, and recurrent urinary tract infections.Additionally, she was found to have extensive pan cystitis cystica with a significantly altered voiding pattern and a very deep-seated mid-urethral sling just beneath the urethral mucosa encircling the urethra completely.During the procedure, cystoscopy revealed that the proximal urethra was elevated and flattened due to the sling compression.Examination of the vagina revealed an exceptionally pulled up and tight sub urethral area from the sling underneath with a scar line.Posteriorly, as noted before, there was a posterior line of the scar with a tight and narrow mid-vaginal section barely accepting one finger.A short incision vas made along the line of the scar noted underneath the urethra.The sling was released and carefully peeled off from the sub urethral area.Fulminant bleeding was encountered; therefore, no additional effort was made to continue further dissection of the tension-free vaginal tape (tvt).Cystoscopy was repeated after releasing the sling;, confirming the urethra was back to a more normal round position.After closing the vaginal incision, bladder fulguration was performed to address the extensive pan cystitis cystica.The patient was awakened in the recovery area in good condition.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted during a transvaginal mesh mid-urethral tape sling repair procedure performed on (b)(6) 2013, for the treatment of stress urinary incontinence.On (b)(6) 2022, the patient underwent cystoscopy, transvaginal sub urethral sling release, and fulguration of extensive pan cystitis.It was alleged that within 6 months of the implant procedure, the patient developed urge incontinence.In the present, the patient had symptoms of worsening urge incontinence, chronic retention, and recurrent urinary tract infections.Additionally, she was found to have extensive pan cystitis cystica with a significantly altered voiding pattern and a very deep-seated mid-urethral sling just beneath the urethral mucosa encircling the urethra completely.During the procedure, cystoscopy revealed that the proximal urethra was elevated and flattened due to the sling compression.Examination of the vagina revealed an exceptionally pulled up and tight sub urethral area from the sling underneath with a scar line.Posteriorly, as noted before, there was a posterior line of the scar with a tight and narrow mid-vaginal section barely accepting one finger.A short incision vas made along the line of the scar noted underneath the urethra.The sling was released and carefully peeled off from the sub urethral area.Fulminant bleeding was encountered; therefore, no additional effort was made to continue further dissection of the tension-free vaginal tape (tvt).Cystoscopy was repeated after releasing the sling;, confirming the urethra was back to a more normal round position.After closing the vaginal incision, bladder fulguration was performed to address the extensive pan cystitis cystica.The patient was awakened in the recovery area in good condition.

Manufacturer Narrative

Block h11: correction to block h6: patient codes, impact codes, and device codes.Imdrf patient codes e1309 and e232402 have been added for urinary retention and urinary incontinence.Imdrf impact code f1901 has been added for fulguration.Imdrf device code a1502 has been added for tight placement of the mesh.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, 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 e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: imdrf patient code e1310 captures the reportable event of recurrent urinary tract infection.Imdrf patient code e2328 captures the reportable event of obstruction from prior sub urethral sling.Imdrf patient code e1906 captures the reportable event of pan cystitis cystica.Imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e0506 captures the reportable event of fulminant bleeding encountered during procedure.Imdrf impact code f1905 captures the reportable event of transvaginal sub urethral sling release.Imdrf impact code f1901 captures the reportable event of fulguration.

• Brand Name: LYNX 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: 17953731
• MDR Text Key: 325899231
• Report Number: 3005099803-2023-05499
• 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: 12/12/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 12/12/2023
• 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
• Patient Age: 58 YR