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

Model Number M0068502110

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

Patient Problems Erosion (1750); Urinary Retention (2119); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date of the revision surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 fit system was implanted into the patient during a procedure performed on (b)(6) 2016.The patient experienced vaginal exposure that did not heal with conservative treatment after the implant procedure.On (b)(6) 2019, the patient underwent revision and resection of retropubic midurethral sling and cystourethroscopy procedures to treat vaginal mesh exposure of midurethral sling.During the procedure, it was noted that the midurethral sling was properly positioned under the midurethra and was laying flat.Intraoperative cystourethroscopy revealed normal bladder mucosa throughout.No evidence of cystotomy, sutures, lacerations, lesions, or mesh.There was normal efflux of urine from bilateral ureteral orifices.The urethra was noted to be normal and no injury.After removal of the exposed portion of the sling, there was no further sling palpated under the urethra.The patient was then sent to pacu in stable condition.This report was originally submitted via asr.Report identification number: (b)(4).Submission date: april 29, 2019.Asr exemption number: e2013036.Pro code: otn.

Manufacturer Narrative

Additional information: blocks b3, b5, h6: patient codes, h6: impact codes.Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2016 was chosen as a best estimate based on the date of the first mesh removal surgery.Blocks d4, h4: the complainant was unable to provide the suspect device 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 revision surgery surgeon is: (b)(6).Block h6: patient codes e2015, e1309 and e2006 capture the reportable events of atrophy, urinary retention and mesh exposure.Impact codes f1905, f1903 and f2303 capture the reportable events of revision and resection of retropubic midurethral sling, and medications.Block h10: 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 fit system was implanted into the patient during a procedure performed on (b)(6), 2016.The patient experienced vaginal exposure that did not heal with conservative treatment after the implant procedure.On (b)(6), 2019, the patient underwent revision and resection of retropubic midurethral sling and cystourethroscopy procedures to treat vaginal mesh exposure of midurethral sling.During the procedure, it was noted that the midurethral sling was properly positioned under the midurethra and was laying flat.Intraoperative cystourethroscopy revealed normal bladder mucosa throughout.No evidence of cystotomy, sutures, lacerations, lesions, or mesh.There was normal efflux of urine from bilateral ureteral orifices.The urethra was noted to be normal and no injury.After removal of the exposed portion of the sling, there was no further sling palpated under the urethra.The patient was then sent to pacu in stable condition.This report was originally submitted via asr.Report identification number: (b)(6).Submission date: april 29, 2019 asr exemption number: e2013036 pro code: otn additional information received on january 19, 2022: the patient was implanted with an advantage fit system during a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy; robotic assisted laparoscopic sacrocolpopexy; retropubic midurethral sling; and cystoscopy performed on (b)(6) 2016 for the treatment of pelvic organ prolapse (uterine, anterior and posterior) and stress urinary incontinence with urethral hypermobility.On (b)(6) 2016, the patient presented with urinary retention and underwent removal/revision of stress incontinence sling and cystourethroscopy procedures.On history and physical examination on (b)(6) 2019, the following were noted: midurethral sling mesh exposed at prior incision site for which the patient underwent a revision/removal of sling surgery on the same day (the patient previously tried conservative therapy with vaginal estrogen with no improvement); vaginal atrophy for which the patient was prescribed with estrace cream - 1gram twice weekly per vagina at bedtime, and low dose of vaginal estrogen to help with irritatvie bladder symptoms, urinary incontinence and vaginal dryness; and levator spasm for which the patient was to continue vaginal suppository (lidocaine / valium / traumeel) and was encouraged to do pfpt.

Manufacturer Narrative

Correction to block b5.Block b3: the exact event onset date is unknown.The provided event date of july 18, 2016 was chosen as a best estimate based on the date of the first mesh removal surgery.Blocks d4, h4: the complainant was unable to provide the suspect device 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 revision surgery surgeon is: (b)(6).Block h6: patient codes e2015, e1309 and e2006 capture the reportable events of atrophy, urinary retention and mesh exposure.Impact codes f1905, f1903 and f2303 capture the reportable events of revision and resection of retropubic midurethral sling, and medications.Block h10: 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 fit system was implanted into the patient during a procedure performed on (b)(6), 2016.The patient experienced vaginal exposure that did not heal with conservative treatment after the implant procedure.On october 24, 2019, the patient underwent revision and resection of retropubic midurethral sling and cystourethroscopy procedures to treat vaginal mesh exposure of midurethral sling.During the procedure, it was noted that the midurethral sling was properly positioned under the midurethra and was laying flat.Intraoperative cystourethroscopy revealed normal bladder mucosa throughout.No evidence of cystotomy, sutures, lacerations, lesions, or mesh.There was normal efflux of urine from bilateral ureteral orifices.The urethra was noted to be normal and no injury.After removal of the exposed portion of the sling, there was no further sling palpated under the urethra.The patient was then sent to pacu in stable condition.This report was originally submitted via asr.Report identification number: 10655955 submission date: april 29, 2019 asr exemption number: e2013036 - pro code: otn **additional information received on january 19, 2022: the patient was implanted with an advantage fit system during a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy; robotic assisted laparoscopic sacrocolpopexy; retropubic midurethral sling; and cystoscopy performed on june 6, 2016 for the treatment of pelvic organ prolapse (uterine, anterior and posterior) and stress urinary incontinence with urethral hypermobility.The patient experienced incomplete bladder emptying after retropubic midurethral sling, requiring self-catherization.A plan was made to release the sling if the voiding dysfunction continued past 5 weeks.On july 18, 2016, the patient presented with urinary retention and underwent revision/release of stress incontinence sling and cystourethroscopy procedures.During the procedure, the sling was noted to be under tension, compressing the urethra.The sling was dissected free from the vaginal mucosa but left intact against the urethra.The sling was incised at the midline under the urethra, thus releasing tension on the urethra.Intraoperative cystourethroscopy revealed normal bladder mucosa throughout; no evidence of cystotomy, sutures, lacerations, lesions, or mesh; normal efflux of urine from bilateral ureteral orifices; and normal urethra.On history and physical examination on october 24, 2019, the following was noted: midurethral sling mesh exposed at prior incision site for which the patient underwent a revision/removal of sling surgery on the same day (the patient previously tried conservative therapy with vaginal estrogen with no improvement).The sling was noted to be properly positioned under the mid urethra and lying flat.The sling was then cut in the midline.Starting on the left, the sling was dissected out along its course to the inferior pubic rami and then excised.This was repeated on the right.Exam also revealed vaginal atrophy for which the patient was prescribed estrace cream - 1gram twice weekly per vagina at bedtime; and levator spasm for which the patient was to continue vaginal suppository (lidocaine / valium / traumeel) and was encouraged to do pfpt.

• Brand Name: ADVANTAGE FIT 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12232014
• MDR Text Key: 263862922
• Report Number: 3005099803-2021-03666
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2022

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
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 01/19/2022; 04/13/2022
• Supplement Dates FDA Received: 02/17/2022; 05/08/2022
• 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: 56 YR
• Patient Sex: Female