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); Micturition Urgency (1871); Headache (1880); Inflammation (1932); Pain (1994); Unspecified Kidney or Urinary Problem (4503); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Manufacturer Narrative

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.Mesh placement and removal surgeries were both performed by (b)(6) md.Block h6: patient codes e2326, e2401, e2006 and e2330 capture the reportable events of chronic inflammation, diverticulitis, erosion and pain impact codes f1903 and f2303 capture the reportable events of mesh removal 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), 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.**additional information received on january 14, 2022: the patient underwent a vaginal hysterectomy, bilateral intraperitoneal uterosacral ligament suspension, perineorrhaphy, placement of advantage fit retropubic mid urethral sling and cystoscopy procedures on (b)(6), 2018 for the treatment of symptomatic stage 3 pelvic organ prolapse; and stress mixed urinary incontinence, with severe stress incontinence and some evidence of intrinsic sphincteric deficiency.The procedure completed with no complications.On (b)(6), 2018, the patient presented with complaints of sensation of a "stitch" in her vagina and her rectal area being "pulled up" that could be due to her vaginal suspension.Diagnoses included: mesh erosion for which conservative management was advised (vagifem alternating with metrogel everyday x 1 month); and diverticulitis.The patient's problem list included fecal incontinence, post-op pain, and mixed urinary incontinence.On (b)(6), 2019, the patient presented for follow-up for mesh erosion.She was not sure if vagifem and metrogel helped with erosion.On digital exam, a 1x0.5 cm area of mesh erosion was noted on the left of the midline in mid-urethra and this was not tender to palpation.Her diagnoses included: mesh erosion for which mesh excision was discussed; stress urinary incontinence with her symptoms unchanged despite midurethral sling placement; urge urinary incontinence for which the patient was advised to increase her dose of mirabegron to 50mg/day; and sensation of rectum being "pulled up" which was likely due to vaginal suspension.On (b)(6), 2019, the patient presented for midurethral sling partial removal and cystoscopy for the treatment of mesh erosion from midurethral sling placement.Pathology results of the submitted vaginal mesh specimen included reactive fibrous tissue with acute and chronic inflammation; and histiocytic reaction to foreign material consistent with mesh material.On (b)(6), 2019, the patient reported that she had no pain.During the exam, she was healing well after the midurethral sling removal.However, she presented with mixed urinary incontinence for which she was advised to continue mirabegron 50mg daily extended release as this dose was helping her, and continued constant sensation of rectum being "pulled up." on (b)(6), 2019, she presented with rectal pain, sensation of a bulge in her vagina, intermittent constipation, diarrhea, loss of liquid stool and lower back pain.She also reported the following: sensation of incomplete bladder emptying.However, upon examination, there was no evidence of urinary retention; and lowering the dose of mirabegron to 25 mg through her pcp due to headaches and reported they had gotten better.Her diagnoses included: pop-q stage 2 rectocele for which she decided to proceed with pelvic floor physical therapy for rectal pain and left groin pain; and diverticulitis for which the patient was referred to gi clinic to address new diagnosis of diverticulitis and assist with the symptoms.She was also recommended to stop miralax due to fecal incontinence and use a bag balm for inner buttock area.On (b)(6), 2019, the patient reported pelvic pain that resolved with pfpt; however, she was still experiencing prolapse and episodes of diverticulitis.On (b)(6), 2019, the patient reported mixed urinary incontinence with cough, laugh and sneeze.Her assessments included pelvic organ prolapse and mixed urinary incontinence.The physician decided not to place another mesh as a treatment in light of the patient previously had mesh erosion.On (b)(6), 2019, the patient presented for a preoperative visit and uds appointment.Her assessments included recurrent prolapse and urinary urge incontinence.On uds, the patient was negative for leaking with cough or valsalva.She was recommended to continue mirabegron for urge symptoms.On (b)(6), 2019, the patient presented for the following procedures: sacrospinous ligament fixation; examination under anesthesia eua; perineorrhaphy/perineoplasty; and cystoscopy (sn).She was diagnosed with recurrent pelvic organ prolapse stage ii.After the procedure, the patient passed her voiding trial but some minimal hematuria was noted with the trial.She was asked to report any continued hematuria.Furthermore, she had slightly low urine output overnight after surgery, but her urine output returned to normal prior to discharge.Additionally, she rated her pain as very well controlled.

• 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 47480
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11520955
• MDR Text Key: 242040517
• Report Number: 3005099803-2021-01027
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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: 02/18/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 02/11/2022
• 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): Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female