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 Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Micturition Urgency (1871); Unspecified Infection (1930); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Injury (2348); No Code Available (3191); Unspecified Mental, Emotional or Behavioural Problem (4430); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2017, 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 sling device was implanted was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient had experienced an unspecified injury after the procedure.Subsequently, the patient had undergone a second surgery on (b)(6) 2019 due to mesh complications.Reportedly, the patient was also implanted with a non-bsc mesh on (b)(6) 2017.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total abdominal hysterectomy + bilateral salpingo-oophorectomy + abdominal sacralcolpopexy + tension-free vaginal tape procedure performed on (b)(6), 2017 for the treatment of pelvic organ prolapse.As reported by the patient's attorney, the patient had experienced an unspecified injury after the procedure.On the same date the advantage fit - single device was implanted, (b)(6), 2017, the patient was also implanted with ethicon gynecare gynemsh.Subsequently, the patient had undergone a second surgery on (b)(6), 2019 due to mesh complications.Additional information received on march 16, 2023.As reported by the patient's attorney, since receiving the meshes, the plaintiff had suffered from mesh complications.On or about (b)(6), 2019, the plaintiff had another surgery due to mesh complications.The plaintiff sustained injuries including infections, mesh complications, the need for additional surgery, chronic pain and mental injuries.Plaintiff sought past and future costs of health care services.The plaintiff had sustained severe damages, loss and expense.Clinical notes: (b)(6), 2021 patient had the tvt removed in 2019 due to pain.She had been experiencing chronic abdominal pain since the removal surgery.She described the pain as grating and a daily 10 of 10 intensity and diffused.Worse with prolonged sitting, ambulation or exercise and limited her activity significantly.She did not take any medication for this issue.She also felt she could not palpate the mesh digitally inside the vagina.She was also concerned of a sensation of incomplete emptying.She had occasional urge incontinence.Off note, she had a prior history of diverticulitis, not ibd, requiring a resection and inoperable of a sacral meningioma.Pelvic examination: her urine dip showed trace leukocytes.There was tenderness in all 4 quadrants of the abdomen.Vaginal mucosa was severely atrophic.There was stool in the rectum which was also painful to palpation.Investigation in august 2021: ct abdomen showed a small amount of recurrent diverticulosis disease, grade 1 anterolisthesis.Right intramuscular lipoma of gluteus medius muscle.Impression: pelvic floor muscle spasm, diverticulosis, chronic abdominal pain.Management plan: removal of the previous sacrocolpopexy mesh versus management of pelvic floor muscle spasm conservatively.She declined conservative management and went for mesh removal.This entailed a pfannenstiel incision of prior sacral colpopexy mesh, insertion of bilateral ureteric stents with cystoscopy and lysis of adhesions.Clinical notes on (b)(6), 2022: in the last evaluation 3 years ago, there was some left - sided abdominal pain and diarrhea, but investigations including ct were unrevealing.Patient was referred for mesh removal surgery which was anticipated to be difficult due to scarring.Additionally, due to bowel issue, it was prudent to do a bowel prep and marker for a colostomy preoperatively.Clinical notes on (b)(6), 2022: preoperative note from a hysterectomy in 2017 was a total abdominal hysterectomy, bilateral salpingo - oophorectomy, abdominal sacralcolpopexy, tension - free vaginal tape.The mesh was likely closely adherent to the bowel.Patient experienced issues with urinary retention and infection as circumstances around the operation in 2017.Thus, there was a possibility of bowel resection and the risk of a stoma particularly.On (b)(6) 2022, due to chronic pelvic pain, the patient had to undergo laparotomy exploratoy, cystoscopy with insertion of stent ureter prior to procedure and bowel resection procedures to remove the mesh.Exploratory laparotomy revealed that a loop of small bowel was adherent to the upper aspect of the mesh that was secured at the presacral fascia at the sacral promontory.With appropriate exposure, the mesh was divided, leaving parts of the mesh on the small bowel loop and parts on the presacral fascia.Additional lysis of adhesions was done to exteriorize the loop of small bowel with the adherent mesh.On examining it and performing further lysis of adhesions, there were 2 pieces of mesh stuck to bowel.Each was about 2x5mm in size and was sharply dissected off of the serosa of the bowel.After having packed off the small bowel in the upper abdomen, the mesh that was adherent to the presacral fascia was in the middle, well away from both ureters which had been stented previously.This was dissected off the presacral fascia and sent off for pathology.Further exploration revealed that the left colon, sigmoid and rectum were not at all involved in the mesh.In a postoperative visit on (b)(6), 2022, patient reported to have nausea, vomiting and diarrhea.She presented in the emergency room for assessment, and she was cleared for any bowel obstruction and was discharged home.She was instructed to take imodium, and this resolved her diarrhea.Patient also stated that she had no pain, bowel and bladder function had returned to normal.She felt much better that the mesh had been removed.

Manufacturer Narrative

Blocks a1, a4, b3, b5, b7, section e.Initial reporter, e1 below and h6 patient codes and impact codes have been updated based on the additional information received on march 26, 2023.Block b3 date of event: date of event was approximated to september 20, 2019, the date of the first mesh removal surgery, as no event date was reported.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 device was implanted at: (b)(6).Explant surgeon: (b)(6).Block h6: imdrf patient codes e2101, e2330, e1002, e1715, e1906, e1309, e1310, e2401, e2015, e1715 and e0206 capture the reportable events mesh stuck to bowel and mesh was likely closely adherent to the bowel; chronic pelvic pain, worse with prolonged sitting, ambulation or exercise and limited her activity significantly; chronic abdominal pain; incomplete emptying, urinary retention; infection; urine dip showed trace leukocytes; mesh complications, severe damages; scarring; vaginal mucosa was severely atrophic and mental injuries.Imdrf conclusion codes f1903, f1905 and f1901 capture the reportable events of complete mesh excision in 2022, mesh removal in 2019, and bowel resection and lysis of adhesions.Block 11: g2: report source has been corrected.

• 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: 10141473
• MDR Text Key: 194778959
• Report Number: 3005099803-2020-02176
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 67 KG