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 Fatigue (1849); Incontinence (1928); Pain (1994); Malaise (2359); Prolapse (2475); Weight Changes (2607); Constipation (3274)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2020, implant date, 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 h6: imdrf patient code e2330 captures the reportable event of chronic pain from the first implant surgery.

Event Description

Note: this manufacturer report pertains to the second of two devices implanted in separate procedures.Please reference report number 2124215-2024-17936 for the details of the first procedure.It was reported to boston scientific that an uphold vaginal support system was implanted into the patient during a procedure performed on (b)(6) 2017, for the treatment of pelvic organ prolapse (pop).Following the procedure, the patient had acute pelvic and leg pain.The tension of the mesh placement was too tight, and second surgery was needed to release the mesh.It was noted that prolapse reoccurred with two months of implant.On (b)(6) 2020, a second implant procedure was performed in which an upsylon y-mesh kit was implanted to treat the pop; however, the prolapse re-occurred again within three weeks from implant.The patient had incontinence and bowel pain as well as continuing chronic pain from first implant surgery.The patient had been experiencing weight gain, cirrhosis, chronic general fatigue and malaise, constipation, and the decreased ability to walk or mobilize with pain.No additional information was reported.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18975675
• MDR Text Key: 338550209
• Report Number: 2124215-2024-16727
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318220
• Device Catalogue Number: 831822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other