MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Prolapse (2475); Dyspareunia (4505)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an upsylon device was used during a total vaginal hysterectomy with right salpingectomy, robotic-assisted sacro colpopexy, rectocele repair, and lynx sub urethral sling, and cystoscopy procedure performed on (b)(6) 2019, for the treatment of pelvic organ prolapse, stress urinary incontinence and urethral hypermobility.On (b)(6) 2022, the patient underwent a series of procedures due to vaginal apical mesh erosion, dyspareunia and pelvic pain, and recurrent anterior vaginal vault prolapse.During the procedure, it was found that there were dense adhesions of the small bowel and colon to the left lateral pelvic sidewall and the posterior cul-de-sac.Approximately 25-30 minutes of lysis of adhesions and enterolysis were performed to safely mobilize the bowel out of the pelvis so that the mesh excision could be performed.Once the bowel was mobilized, the mesh was identified and tracked down to the vagina.Mucus discharge was noted toward the left apical aspect of the vagina, consistent with the area of mesh erosion.Multiple gore-tex stitches and mesh were found to be eroded through the apex of the vagina.During dissection of the mesh, it was noted that the mesh had eroded into the vagina and into the posterior aspect of the bladder.The mesh finished being dissected from the anatomy and then multiple layers of the bladder mucosa were reapproximated.Additionally, an ovarian cyst was identified and removed.There were no patient complications reported.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of may 5, 2022, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e2006 captures the reportable event of mesh erosion.Imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2330 captures the reportable event of pelvic pain.Imdrf impact code f19 captures the reportable event of excision of previously placed mesh.Imdrf impact code f1901 captures the reportable event of ovarian cystectomy.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19040895
• Report Number: 2124215-2024-19162
• Device Sequence Number: 8548294
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C003935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female