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 Hemorrhage/Bleeding (1888); Laceration(s) (1946); Internal Organ Perforation (1987)

Event Date 03/12/2007

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a laparoscopic - assisted vaginal hysterectomy + bilateral salpingo-oophorectomy + laparoscopic lysis of adhesions + tvt + cystoscopy + laparotomy and repair of cystotomy + placement of suprapubic jp + bilateral ureteral stent placement and removal procedure performed on (b)(6) 2007 for chronic pelvic pain and stress incontinence.Operative findings showed an anteverted uterus with very dense adhesions on the left.The left tubo-ovarian complex was approximately 6cm in size and densely adherent to the left sidewall and left sigmoid.The right ovarian complex was about 4cm in size.It was densely adherent to the uterus.There was a normal liver edge seen and an absent appendix.Patent ureters bilaterally.A cystotomy was identified approximately 2 inches away from the trigone and the posterior back edge of the bladder.All the adhesions between the left tubo-ovarian complex, left ureter, the left sigmoid to the uterus, and the right ovarian tubal complex was isolated off the right ureter and right sidewall.After completion of the lysis of adhesions, the ureters were visualized bilaterally.The hysterectomy and anterior colpotomy were performed.Bleeding was encountered from an aberrant branch of the uterine and was clamped, ligated, and clipped with good hemostasis.The vaginal incision for tvt placement was created and extended right and left of the urethra behind the pubic bone where the tvt would be placed.Once the bladder manipulator was placed, bloody urine was visualized.The tvt was then placed in a standard fashion directly behind the pubic bone aiming at the shoulder.Cystoscopy was performed and some frank blood was seen in the bladder which was easily irrigated.Both ureters were seen and found to be peristalsing.There was a small laceration seen at the posterior part of the bladder, but appeared to be superficial.The tvt was then advanced, placed against the urethra with a 10 hegar and the sheath was then excised.Care was taken to avoid incorporation of the tvt mesh with the vaginal mucosa and it was then closed using a running locking stitch of 2-0 vicryl.Copious irrigation was used and the vagina was found to be hemostatic.The laparoscope was then re-inserted and a large amount of very bloody fluid was seen.It was irrigated out and a small approximately 4mm hole in the bladder was visualized.Attempted to close it laparoscopically with 3-0 chromic, but was unable to keep a pneumoperitoneum going due to the loss through the vagina and the bladder.Terminated the laparoscopic procedure and did a pfannenstiel incision and carried it with traction and the peritoneum was entered.The large amount of fluid was then irrigated out.Moist laps and o'connor o'sullivan retractor were used to pack bowel up.The incision was found to be above the trigone, approximately 3 inches posterior to the dome and in the back of the uterus.Attempted to closed it in a two-layer technique using 2-0 and 3-0 chromic, but it continued to ooze.Cystoscopy showed there was still a small hole at the posterior part of the bladder.The bladder defect was closed using a three-layer technique over the incision; the laceration with 3-0 and 2-0 chromic.The dome of the bladder was closed using a running 2-0 chromic stitch followed by interrupted 3-0 chromic stitches.Drains at the end of the case were a jp suprapubic and a foley.Pathology specimen sent were uterus, ovaries, tubes and cervix.Patient was extubated in the operating room and taken to the recovery in good condition.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeons are: (b)(6).(b)(4).The complaint device 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.

• 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: 15217189
• MDR Text Key: 297785983
• Report Number: 3005099803-2022-04491
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2022

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: 07/20/2022
• Initial Date FDA Received: 08/12/2022
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female