MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number M0068318220

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

Patient Problems Discomfort (2330); Prolapse (2475); Dyspareunia (4505); Insufficient Information (4580)

Event Date 03/15/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh kit was implanted during a laparoscopic sacrocolpopexy and cystoscopy procedures performed on (b)(6) 2014 to treat vault prolapse.During the procedure, an attempt was made to remove the right side of an anterior elevate eyelet.The anterior eyelet, a non-bsc mesh device, had been implanted in 2012 on (b)(6) 2017, the patient sought consult as she continued to experience symptoms such as "displaced tampon feeling" and the patient also described "a grating feeling." moreover, the patient also reported to have some right sided discomfort with intercourse.These issues occurred prior to the laparoscopy procedure she underwent in 2014.The patient was aware of a vaginal bulge which is to the level of the introitus.When the patient was lying down, she said she had no feeling of a vaginal bulge or discomfort.The patient noted that the right sided discomfort occurred when she was crossing her right leg when seated or standing.On examination, there was an anchor or eyelet which was tender and deep in the right sacrospinous space.The left was also palpable but this was not tender.There was no evidence of mesh exposure.There was anterior vaginal wall descent to one centimeter below the hymen.The vaginal vault was well supported as is the posterior wall.A long discussion with the patient regarding the fact that even if the right anchor or eyelet was removed, this may result in improvement of discomfort by about 50%.In the physician's assessment, there was the possibility of bleeding and a very low likelihood of bladder or bowel injury.It was also discussed that as the approach was most likely to involve the anterior wall, an anterior vaginal wall repair with native tissue can be performed.However, this has an inherently low success rate for revision of prolapse but it also has a low rate of ongoing complication compared with mesh procedures.On (b)(6) 2019, the patient returned for review.She was not currently significantly troubled by dyspareunia nor the vaginal pain.She was managing with this; however, she was bothered by the symptomatic bulge, which was her main concern.On examination, there appeared to be a low cystocele and the proximal ridge of the elevate was palpable.There was anterior vaginal wall descent to the hymen and there was levator avulsion.On 3d ultrasound, the anterior mesh was noted and there was a global failure of the anterior mesh with descent seen along the whole of the anterior wall.Possible treatment options were discussed such as native tissue repair with sutures, a fascia lata reinforced repair, or a repeat sacral colpopexy with paravaginal repair.A urodynamic assessment would be organized and possibilities of surgeries would be discussed.Potentially, the repeat sacral colpopexy would be more likely to be associated with a longer term improvement.However, the patient understood that repeat surgery is more complicated.The patient was planning to undergo repeat surgery in mid 2020.

Manufacturer Narrative

Initial reporter: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(premarket / 510(k) #): enforcement discretion.(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: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15285721
• MDR Text Key: 298518844
• Report Number: 3005099803-2022-04450
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Device Lot Number: C001999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female