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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502110
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Diarrhea (1811); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Blurred Vision (2137); Urinary Frequency (2275); Anxiety (2328); Prolapse (2475); Weight Changes (2607); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)
Event Date 10/19/2009
Event Type  Injury  
Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6) at (b)(6) medical center.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.E2006 - eroded mesh.E1405 - painful sexual intercourse.E1301 - dysuria.E1309 - urinary retention.E232402 - urinary incontinence.E1304 - mitigation urgency.
 
Event Description
It was reported to boston scientific that an advantage fit system was implanted into the patient during an advantage retropubic mid-urethral incontinence sling procedure performed on (b)(6) 2009, for the treatment of stress urinary incontinence.After the procedure, the patient went to the recovery room in good condition with no complications.On (b)(6) 2023, the patient underwent a routine colonoscopy screening which revealed an embedded foreign body in the cecum with associated surrounding granulation tissue and overlying formation of mucosal bar above foreign matter.The abnormal area was localized visually, and targeted biopsies were taken from likely granulation tissue at the base of the embedded foreign body.It is likely suspected to be related to her history of bladder sling possibly eroding through the colon wall.On (b)(6) 2023, magnetic resonance imaging (mri) of the abdomen with and without contrast was performed and showed no obvious mass or abnormal enhancement involving the visualized bowel loops.Mri findings are indeterminate and inconclusive to the etiology of the colonoscopy findings.On (b)(6) 2023, the patient presented for consultation for a bladder sling pushing on the colon wall.The physician reviewed the scanned colonoscopy images from january 24, 2023, and confirmed that there is a linear strip of tan woven calcified material that is embedded into the wall of the cecum.The final pathology from the biopsy at this site shows benign colonic mucosa with intramucosal lymphoid aggregate, calcification, and foreign body material.The patient was unaware of any problems prior to the colonoscopy being performed, but at this time, wonders if the intermittent abdominal cramps and sharp pains she has experienced over the past few years may be related.She has difficulty passing bowel movements and uses hands to vaginally splint the perineum to defecate.Denies bulge from the vagina but reports perineum does bulge with straining.The patient has had increased urinary frequency within the past four to five years and occasional leakage with urgency.The patient noted some post-void dribbling and occasional leakage with coughing and sneezing in the past year and a half; however, it was mentioned that the symptoms were which was much better prior to her sling surgery.Additionally, the patient allegedly voids every fifteen minutes to two hours during the day, five to six times per night, and endorses urinary urgency.Endorses loss of urine associated with urgency two to three times per week, occasional loss of urine with sneezing again within the past one and a half years, still much better than before, and sensation of incomplete void, due to symptoms of urgency.The patient reported intermittent right-sided pelvic pain over the past few years.The patient is sexually active; however, the patient noted painful sexual intercourse as it feels like something is being hit.She has been taking over-the-counter medications for estrogen, difficulty with sleeping, and hot flashes.On a pain scale of 10, she rates her symptoms of heaviness/dullness or pressure in the pelvic area as 1/10, feeling bulge or something falling out of the vagina as 1/10, pushing on the vagina or rectum for a bowel movement (stool gets caught) as 2/10, pushing on the vagina to start or complete voiding as 1/10, incomplete bowel emptying as 2/10, loss of formed stool as 1/10, loss of liquid stool as 1/10, loss of urine with feeling of urgency as 1/10, loss of urine with cough/sneeze/laugh or strain as 2/10, difficulty emptying bladder as 2/10, uncomfortably strong urge to urinate as 1/10, burning when passing urine as 1/10, pain in lower abdomen/genital area as 1/10, and pain with intercourse as 2/10.The medications prescribed to the patient were tapazole 10 mg, cozaar 50 mg, cyanocobalamin, and xanax 0.25 mg.During the physical examination, tenderness to palpation was noted along the suprapubic region.Stage ii rectocele noted.There was mild tenderness to palpation present in the vagina.Mild banding of the left periurethral skin was also present; however, it was not tender.The physician's impression included a foreign body in the cecum, an overactive bladder with urge urinary incontinence, stress urinary incontinence without urethral hypermobility, and pelvic organ prolapse.The diagnosis and pathology therapeutic options were discussed at lengths, including risks and benefits.The patient decided to proceed with a urodynamic study to assess bladder capacity compliance, and the presence of detrusor overactivity, and a diagnostic cystoscopy to rule out intravesical pathology or mesh erosion into the bladder or urethra.On (b)(6) 2023, the patient underwent cystourethroscopy, urethroscopy of the urethra and cystoscopy of the bladder.Urethroscopy of the urethra performed with a 0-degree urethroscope revealed normal appearance, and no evidence of erythema, stones, polyps, and diverticulum ostla.There was no mesh erosion or hypermobility.Cystoscopy of the bladder performed with a 70-degree panendoscope revealed a normal appearance, and no erythema, stones, polyps, lesions, and mesh erosion.Mild indentation from the presumed retropubic mid-urethral sling mesh arm that was more lateral than anticipated on the right side has been noted.Does not appear to be putting tension on the urothelium, not visually consistent with a bladder perforation.No appreciable indentation along the left side.There was bilateral ureteral efflux.Mild trabeculations were observed at 250ml.Filled to the maximum capacity of 250ml, negative cough stress test with and without prolapse reduction.On (b)(6) 2023, urodynamic studies were performed and showed continuous, fluctuating flow on uroflowmetry and post-void residual of 10 ml, stress urinary incontinence was not noted with or without prolapse reduction throughout the study and mean urethral closure pressures were normal (82cm h20) without prolapse reduction and mean urethral closure pressures were normal (53cm h20) with prolapse reduction.No early onset of intrinsic sphincter deficiency.There was no detrusor overactivity.There was increased sensation (first desire 231ml, strong desire 251ml) and decreased capacity (290 ml).Normal compliance.On (b)(6) 2023, urodynamic studies were performed and showed normal sensation (first desire 223ml, strong desire 258ml) decreased capacity (331 ml), and normal compliance.Stress urinary incontinence and detrusor instability were not noted.Intermittent flow on voiding pressure flow study with p det at q max of 0 cm h20.Void of 283 ml and post-void residual volume of 20 ml, valsalva-predominant mixed mechanism, minimal urethral relaxation during the void, relaxed pelvic floor musculature during the void.On (b)(6) 2023, the patient presented for follow-up and notified she would have a consult with the physician who would perform the colorectal surgery on august 18, 2023.The patient reported being curious if the surgical removal would help with her difficulty passing bowel movements as she feels that the stool is "getting caught." on a pain scale of 10, she rates her symptoms of heaviness/dullness or pressure in the pelvic area as 2/10, feeling a bulge or something falling out of the vagina as 1/10, pushing on the vagina or rectum for bm (stool gets caught) as 2/10, pushing on the vagina to start or complete voiding as 1/10, incomplete bowel emptying as 3/10, loss of formed stool as 1/10, loss of liquid stool as 1/10, loss of urine with feeling of urgency as 2/10, loss of urine with cough/sneeze/laugh or strain as 2/10, difficulty emptying bladder as 3/10, uncomfortably strong urge to urinate as 2/10, burning when passing urine as 1/10, voids during the day every 4-5/10 per hour, number of night-time voids 4-5/10, pain in lower abdomen/genital area as 2/10, and pain with intercourse as 3/10.Medications prescribed to the patient were xanax 0.25 mg, cyanocobalamin, cozaar 50 mg, tapazole 10 mg, and gemtesa 75 mg.The visit diagnoses are the following: overactive bladder, female stress incontinence, urinary frequency, foreign body in cecum, rectocele, urge incontinence, urgency of urination, and urinary urgency.The physician's impression included a foreign body in the cecum, an overactive bladder with urge urinary incontinence, stress urinary incontinence without urethral hypermobility, and pelvic organ prolapse.It was further explained to the patient that if she's currently asymptomatic, the risks of surgery may outweigh the benefits and expectant management of mesh erosion into cecum could be considered.Will finalize the plan after she has seen the physician.Discussed the options of anti-cholinergic and b3 agonist as 2nd line therapy for overactive bladder as well as the potential risks and side effects.The patient declines anti-cholinergic therapy given concerns about side effect profile and cognitive decline with long-term use.Proceeding with b3 agonist therapy (mirabegron or gemtesa) has been recommended and a prescription added.The physician recommended that a id-urethral sling should not be placed at the same time as the bowel resection to avoid risks of infection.Additionally, it was discussed that correcting the mesh erosion into the cecum will not impact defecation.Rather, a posterior colporrhaphy could be beneficial and this could be performed at the same time or independently of a robotic laparoscopic mesh excision.On (b)(6) 2023, the patient presented for consult as she was referred for evaluation and management of bladder sling erosion into the cecum.The patient noted that over the last two years, she has had occasional right lower quadrant stabbing pain, occasional constipation, and splints in her perineum.She rarely sees blood in her bowel movements.Has had a routine colonoscopy on january 24, 2023, that demonstrated a foreign body in the cecum.Colon polyps were also noted.A pathology report showed tubular adenomas (2), no high-grade dysplasia identified, benign colonic mucosa with intramucosal lymphoid aggregate calcification and foreign body material, benign hyperplastic polyp, and no dysplasia identified.She has had recent weight gain, blurry visions, occasional leg swelling, diarrhea, constipation, urinary frequency and urgency, joint pain, and anxiety.The physician's impression during the visit included asymptomatic mesh erosion into the cecum.The operative and nonoperative approaches as well as their potential risks have been discussed with the patient.Given that she is relatively asymptomatic and that the mesh has been incorporated for more than 10 years, it would be reasonable not to perform surgery.The patient understood these risks and would like to think about surgery.The physician has asked the patient to follow up as needed.
 
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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
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18615396
MDR Text Key334257342
Report Number2124215-2024-04247
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729772880
UDI-Public08714729772880
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2012
Device Model NumberM0068502110
Device Catalogue Number850-211
Device Lot Number0ML9081801
Was Device Available for Evaluation? No
Date Manufacturer Received01/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age57 YR
Patient SexFemale
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