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

Model Number M0068502120

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

Patient Problems Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Unspecified Mental, Emotional or Behavioural Problem (4430); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event was approximated to june 13, 2022, first clinic visit date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Revision surgery performed by (b)(6).Block h6: patient code e1405 captures the reportable event of "felt vaginal dryness and pain causing her to stop intercourse," dyspareunia, "pain with attempts for vaginal intercourse," and pain with coitus.Patient code e0206 captures the reportable event of "decreased her physical activity," and "strain on her marriage and she was seeing a counselor." patient code e1906 captures the reportable event of yeast infection.Patient code e1307 captures the reportable event of urinary stricture.Patient code e1310 captures the reportable event of "treated for urinary tract infection (uti)," and "bacterial infection." patient code e1401 captures the reportable event of "green vaginal discharge," "two (2) episodes of clear vaginal discharge," and abnormal vaginal discharge.Patient code e2326 captures the reportable event of vaginitis.Patient code e1302 captures the reportable event of "small blood clots when urinating," and hematuria.Patient code e2015 captures the reportable event of "introitus felt swollen," and vaginal atrophy.Patient code e0506 captures the reportable event of bleeding, vaginal spotting, intermittent spotting, and bleeding when attempting vaginal intercourse.Patient code e2330 captures the reportable event of "palpable tenderness along the transverse anterior vaginal wall," vaginal/pelvic pain, hot burning type of pain, vaginal and pelvic pain at 5 out of 10 located vaginally, in the suprapubic area, and groin area, episodically the pain increased, vaginal pain, pelvic pain, urethral pain, and groin pain.Patient code e2401 captures the reportable event of "complication of implanted vaginal mesh (unspecified)." impact code f1903 captures the reportable event of explant surgery performed.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that an advantage fit blue system was used during a midurethral retropubic sling placement and cystoscopy procedure performed on (b)(6) 2022, to treat a patient with stress urinary incontinence.There were no complications during the implant procedure.The patient tolerated the procedure well and she was taken to the post anesthesia care unit (pacu) in stable condition.On (b)(6) 2022, the patient was seen and examined for a sling check and complaints of bleeding.The patient went on a vacation and had a lot of intercourse with no problems.Upon return, the patient had intercourse with no lubrication and was using claritin.The patient felt vaginal dryness and pain causing her to stop intercourse.She then experienced urinary urgency and frequency.There were also small blood clots when urinating.The patient went to urgent care for this and was treated for urinary tract infection (uti) with a course of amoxicillin.However, the culture came back negative.She was told by urgent care that she had a bacterial infection and was started on flagyl.The patient felt like she may be getting a yeast infection.She did not have fever, chills nor flank pains.The patient had mild urgency during the visit.In the physician's assessment, the patient had vaginal atrophy, yeast infection, and hematuria.On (b)(6) 2022, the patient was seen and examined for complaints of dyspareunia, spotting and incontinence.The patient reported pain with attempts for vaginal intercourse.She reported her introitus felt swollen.The patient also noted a sudden snapping/popping sensation.Recently, she noted a green vaginal discharge and some spotting.The patient also noticed two (2) episodes of clear vaginal discharge (possibly urine).The patient verbalized her concern about fistula or mesh erosion.In the physician's assessment, the patient had dyspareunia, urinary leakage and vaginitis.Upon cystoscopy, the patient was negative for fistula or mesh extrusion into the bladder.Physical exam also revealed negative vaginal mesh extrusion.The physician noted a palpable tenderness along the transverse anterior vaginal wall.On (b)(6) 2023, the patient was seen and examined for complaints of vaginal/pelvic pain and spotting.Since the patient's last visit in (b)(6) 2022, the patient had tried estrogen cream and then imvexxy estrogen replacement.She had abstained from vaginal intercourse and decreased her physical activity in hopes that her dyspareunia would improve.The patient reported that with attempts for vaginal intercourse she felt a hot burning type of pain and vaginal intercourse was not possible.Her husband described feeling something vaginally upon penetration.The patient also reported abnormal vaginal discharge and intermittent spotting and bleeding when attempting vaginal intercourse.The patient reported her vaginal and pelvic pain at 5 out of 10 located vaginally, in the suprapubic area, and groin area.Episodically the pain increased.She reported decreasing her physical activity further and taking tylenol, but this did not help her with the pain.The patient's inability to have intercourse placed a strain on her marriage and she was seeing a counselor.In the physician's assessment, the patient had pelvic pain, complication of implanted vaginal mesh (unspecified) and vaginitis.Upon magnetic resonance angiography (mra) of pelvis (with and without contrast), it was noted that the patient had pelvic floor muscle spasm and dysfunction involving the muscles of the upper and medial thigh bilaterally.It was explained to the patient that her pain and discomfort was from the levator muscle dysfunction.Pelvic floor physical therapy was recommended, and they discussed removal of the suburethral portion of sling vs.Excision of the entire length of the sling.On (b)(6) 2023, the patient underwent an advantage sling removal, removal of abdominal mesh procedures to treat vaginal pain, pelvic pain, urethral pain, groin pain, pain with coitus and urinary stricture.In the physician's assessment, the surgery was difficult due to the right and left sling arms being in the obturator muscles.The right arm was very deep in the obturator muscles.The sling was superficial in the right sulcus.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.After the removal, cystoscopy was performed and confirmed no injury to the internal aspects of the bladder integrity and jets of urine were noted from both ureteric openings.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

• Brand Name: ADVANTAGE FIT BLUE 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
• MDR Report Key: 18527359
• MDR Text Key: 333046833
• Report Number: 2124215-2024-01819
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502120
• Device Catalogue Number: 73189
• Device Lot Number: 0028444692
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female