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

Model Number M0068502000

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

Patient Problems Incontinence (1928); Urinary Retention (2119); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Hematuria (2558); No Code Available (3191); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 10/01/2010

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during complex prolapse and continence surgery performed on (b)(6) 2010.As reported by the patient's attorney, after the implantation, the patient experienced some non-specific laparoscopic hematuria, oversensitive and overactive bladder and voiding dysfunction.On (b)(6) 2011, the patient underwent division of tension-free vaginal tape that was causing some obstructive symptoms.Cystoscopy was also performed and revealed some mild to moderate trabeculation and a couple of bladder neck cysts, the latter were diathermied.The patient underwent revision prolapse and continence surgery on (b)(6) 2013.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during complex prolapse and continence surgery performed on (b)(6) 2010.This procedure involved a four part repair, namely anterior and posterior repair and vaginal vault suspension using either of both the uterosacral and sacrospinous ligaments.On (b)(6) 2011, the patient underwent division of tension-free vaginal tape that was causing some obstructive symptoms.Cystoscopy was also performed and revealed some mild to moderate trabeculation and a couple of bladder neck cysts, the latter were diathermied.For a few days around (b)(6) 2013, the patient experienced some non-specific laparoscopic hematuria.This seemed to settle and all the investigations subsequently were normal.She has not had a repeat of this.On (b)(6) 2013, the patient was assessed and was noted to have ongoing urgency and some urge incontinence and frequency; urgency had been a problem since early 2010 prior to the advantage implant.Upon examination, she was voiding well, there was no residual and the anatomy seemed to be satisfactory.The patient was started on oxytrol patches that gave her some benefit.On (b)(6) 2013, the patient had an exam and urodynamic review which showed recurrent grade 1 cystocele and stress leakage with coughing once the bladder was filled to capacity and the cystocele was reduced.A component of detrusor overactivity was also noted.The patient underwent revision prolapse and continence surgery on (b)(6) 2013.A two layer anterior repair and small posterior repair were performed.The continence procedure was a tension free vaginal tape- advantage.On (b)(6) 2013, the patient's stress incontinence had resolved and her urgency was improved.Per the physician, anatomically all was fine though the physician had to divide a couple of longer lasting pds sutures.The patient should be more sexually comfortable.Residual is up slightly at 75 ml and will need to be monitored.On (b)(6) 2014, the patient was still having urgency and an oversensitive and overactive bladder with a degree of voiding dysfunction, but the residual was down to 33 ml from 75 mls.On (b)(6) 2014, urodynamics showed evidence of posture unstable detrusor function.The urethra looked particularly narrow.The recommended intervention was neuromodulation.Cystoscopy revealed normal urethra, normal bladder, no erosion, and scarring at the dome from previous spc (suprapubic catheter).

Manufacturer Narrative

Correction: two advantage device were implanted during different procedures.The following fields have been updated: block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient codes e1309, e1307 and e2328 capture the reportable events of urinary retention, moderate trabeculation and a couple of bladder neck cyst, and obstruction.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Blocks b5, b6, b7 and e1 below have been updated based on the additional information received on february 17, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).General practitioner: (b)(6).Block h6: imdrf patient codes e1309, e1307, e2328, e1302 and e1405 capture the reportable events of urinary retention, moderate trabeculation and a couple of bladder neck cyst, obstruction, hematuria and dyspareunia.Imdrf impact code f19 and f2301 capture the reportable events of surgical intervention and second advantage device implanted.Block 11: section e.Initial reporter, g2: report source and block h6 above have been corrected.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during an anterior and posterior repair + vaginal vault suspension + sacrospinous hitch + tension free vaginal tape + insertion of suprapubic catheter performed on (b)(6) 2010.This procedure involved a four part repair, namely anterior and posterior repair and vaginal vault suspension using either of both the uterosacral and sacrospinous ligaments.On (b)(6) 2011, the patient underwent division of tension-free vaginal tape that was causing some obstructive symptoms.Cystoscopy was also performed and revealed some mild to moderate trabeculation and a couple of bladder neck cysts, the latter were diathermied.For a few days around (b)(6)2013, the patient experienced some non-specific laparoscopic hematuria.This seemed to settle and all the investigations subsequently were normal.She has not had a repeat of this.On (b)(6) 2013, the patient was assessed and was noted to have ongoing urgency and some urge incontinence and frequency; urgency had been a problem since early 2010 prior to the advantage implant.Upon examination, she was voiding well, there was no residual and the anatomy seemed to be satisfactory.The patient was started on oxytrol patches that gave her some benefit.On (b)(6) 2013, the patient had an exam and urodynamic review which showed recurrent grade 1 cystocele and stress leakage with coughing once the bladder was filled to capacity and the cystocele was reduced.A component of detrusor overactivity was also noted.The patient underwent revision prolapse and continence surgery on (b)(6) 2013.A two layer anterior repair and small posterior repair were performed.The continence procedure was a tension free vaginal tape- advantage.On (b)(6) 2013, the patient's stress incontinence had resolved and her urgency was improved.Per the physician, anatomically all was fine though the physician had to divide a couple of longer lasting pds sutures.The patient should be more sexually comfortable.Residual is up slightly at 75 ml and will need to be monitored.On (b)(6) 2014, the patient was still having urgency and an oversensitive and overactive bladder with a degree of voiding dysfunction, but the residual was down to 33 ml from 75 mls.On (b)(6) 2014, urodynamics showed evidence of posture unstable detrusor function.The urethra looked particularly narrow.The recommended intervention was neuromodulation.Cystoscopy revealed normal urethra, normal bladder, no erosion, and scarring at the dome from previous spc (suprapubic catheter).

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11175551
• MDR Text Key: 227018774
• Report Number: 3005099803-2021-00107
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• 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: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 1ML0051201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female