MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO PFR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Prolapse (2475)

Event Date 09/22/2017

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the first of two devices implanted in separate procedures.Please reference report number 2124215-2024-16727 for the details of the second 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.

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h6: imdrf patient code e2330 captures the reportable code of acute pelvic pain and leg pain.Imdrf impact code f1905 captures the reportable code of the second surgery needed to release the mesh.Imdrf device code a0510 captures the reportable code of too-tight mesh placement.

• Brand Name: CAPIO PFR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18975790
• MDR Text Key: 338546721
• Report Number: 2124215-2024-17936
• Device Sequence Number: 1
• Product Code: OTP
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• 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): Required Intervention; Other