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

Model Number M0068502111

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Erosion (1750); Calcium Deposits/Calcification (1758); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Inflammation (1932); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684); Fibrosis (3167); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the information that the event started approximately years after the implantation on (b)(6) 2012.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The mesh removal surgeon is: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem 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 mid urethral sling and cystoscopy procedure performed on (b)(6) 2012 for the treatment of stress urinary incontinence and terminal detrusor overactivity.After the implantation, on an unspecified date, the patient started to develop trouble in voiding along with stranguria and bladder spasm that caused the worsening of bladder and pelvic pain.She also became globally wet with respect to involuntary urine loss.On pelvic examination, the inflammatory response has made the tissue weak and friable.Options were discussed with the patient and it was elected to divert her urine in an attempt to control the inflammatory response and prepare the tissue for mesh removal and repair.On (b)(6) 2020, the patient underwent a cystoscopy with formal suprapubic cystotomy for the treatment of incomplete bladder emptying.During the procedure, the anterior bladder wall was penetrated with a spinal needle until a good urine backflow was achieved.Then the cystoscope was placed per urethra into the bladder so that the spinal needle was able to be seen protruding from the anterior bladder wall.A catheter was placed down into the bladder where the balloon was blown up under a direct vision.At that point, the wound was copiously irrigated with an antibiotic solution and the wound was closed in layers.The patient tolerated the procedure well.There were no known complications reported.On (b)(6) 2020, the patient presented to the emergency room with sharp pain in her bladder and decreased urine output.She had complained of bladder spasms prior and was given unspecified medications to help.She then noted blood in the urinary catheter.Urinalysis revealed a large amount of blood, nitrate positive leukocyte esterase and white blood cells present in the urine specimen.White count and hemoglobin were normal, and comprehensive metabolic panel showed no significant abnormalities.The patient was diagnosed with a mild urinary tract infection, was given a dose of rocephin in the hospital and was sent home on keflex for continued home medication.On (b)(6) 2020, the patient's inflammatory response had been controlled by urinary diversion with suprapubic catheter and she returned for mesh removal and repair.The patient underwent a cystoscopy with excision of vaginal mesh with matristem grafting and anterior repair for the preoperative diagnosis of eroded vaginal mesh.During the surgical intervention, the eroding mesh was easily visualized.Utilizing a primarily sharp dissection, the mesh was freed up laterally as it went anteriorly around the urethra.The anterior repair was then completed, and any redundant anterior vaginal wall was excised and was sent for pathologic specimen.The matristem graft was placed and fitted to the bare area at the level of the mid urethra which was previously covered by the eroded mesh.A follow up cystoscopy confirmed that there was no inadvertent bladder or urethral injury noted during the surgery.The patient was transferred to the recovery room in a stable condition.Additionally, the surgical pathology report revealed that the patient had chronic inflammatory reaction on her vaginal wall tissue and focal dystrophic calcification associated with dense stromal fibrosis and erosion of the overlying squamous epithelium.On (b)(6) 2021 the patient underwent removal of suprapubic catheter with excision of vesicocutaneous tract/fistula.The perineal excoriation has essentially completely healed but there was increasing discomfort around the spt site, so the patient requested the tube removed and to resume clean intermittent catheterization (cic) if necessary.Under iv anesthesia, the foley was deflated and removed from the tract, after which dissection to the fistulous tract was performed and the anterior bladder wall was reapproximated.The procedure was completed without complications.On (b)(6) 2021 the patient presented with the wound draining purulent material and blood, and the patient was also experienced fatigue, diarrhea, nausea and fever.Exam findings included wound dehiscence with tenderness to palpation, erythema, warmth and moderate brown-tinged watery fluid expressed with palpation.Ct scan showed no findings consistent with abscess but was consistent with cellulitis.The wound was cultured, packed, and dressed.The patient was admitted with abdominal wall cellulitis for antibiotic treatment and evaluation.On (b)(6) 2021, the patient underwent cystoscopy with bladder hydrodistension, and botox injection was interstitial cystitis with severe high volume urgency urinary incontinence.

• 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): 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: 12866426
• MDR Text Key: 282492580
• Report Number: 3005099803-2021-06000
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729784777
• UDI-Public: 08714729784777
• 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,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: M0068502111
• Device Catalogue Number: 850-211
• Device Lot Number: ML00000445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female