MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994); Prolapse (2475); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with an upsylon device, and she claimed to have experienced anterior and posterior vaginal prolapse, mesh migration, and pain as a result of the implantation, which required her to undergo surgical revision/removal procedure.Furthermore, the patient claims to have suffered, or may sustain in the future, the following damages as a result of the implantation of the upsylon device: physical impairment, physical disfigurement, impairment of relationships and earning capacity, emotional distress, pain and suffering, out of pocket cost, and loss of consortium.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, 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: the following imdrf patient code capture the reportable event of: e2006 - erosion.E2330 - pain.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.F1905 - revision.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion, e2330 - pain.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.F1905 - revision.Block h11: blocks b3, d4, d6a, and h4 have been updated.
Event or Problem Description
It was reported that the patient was implanted with an upsylon device, and she claimed to have experienced anterior and posterior vaginal prolapse, mesh migration, and pain as a result of the implantation, which required her to undergo surgical revision/removal procedure.Furthermore, the patient claims to have suffered, or may sustain in the future, the following damages as a result of the implantation of the upsylon device: physical impairment, physical disfigurement, impairment of relationships and earning capacity, emotional distress, pain and suffering, out of pocket cost, and loss of consortium.
Additional Manufacturer Narrative
Block h11: blocks a2 (date of birth and age), a3a (sex), a3b (gender), b5 and b7, d4 (udi), h2, and h6 have been updated based on the additional information received on october 13, 2025.Block b3: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6) hospital; (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - erosion, e2330 - pain.The following imdrf impact code capture the reportable event of: f12 - patient had sought for a legal recourse for injuries related to the device.F1905 - revision.
Event or Problem Description
It was reported that the patient was implanted with an upsylon device for the treatment of bladder prolapse and overactive bladder on (b)(6) 2018.Postoperatively, the plan was for the patient to be discharged the following morning after removal of the vaginal packing and catheter, with instructions to return to the clinic for follow-up in one month.Following the implant, she claimed to have experienced anterior and posterior vaginal prolapse, mesh migration, and pain as a result of the implantation, which required her to undergo surgical revision/removal procedure.Furthermore, the patient claims to have suffered, or may sustain in the future, the following damages as a result of the implantation of the upsylon device: physical impairment, physical disfigurement, impairment of relationships and earning capacity, emotional distress, pain and suffering, out of pocket cost, and loss of consortium.On (b)(6) 2024, the patient was diagnosed with mesh erosion and overactive bladder.She underwent vaginal approach excision/ revision of vaginal mesh or graft, therapeutic botox injected into the detrusor muscle of the bladder one time, cystoscopy, and rectocele repair.During the procedure, a granulomatous polyp measuring greater than 1 cm was identified on the mid-posterior vaginal wall, with palpable mesh located beneath it.The entire vaginal wall was inspected, revealing no additional polyps, exposed mesh, or suture material.The tissue cephalad to the polyp was grasped with a long allis clamp, and the polyp was excised using a scalpel.The specimen was sent to pathology for analysis.The underlying mesh was then exposed, and a 1-cm segment was excised, which resulted in a bulging rectocele.A digital rectal examination confirmed no defect into the rectum.The rectocele was repaired using interrupted vicryl sutures, and the vaginal epithelium was closed with 2-0 vicryl.The urethra was subsequently dilated to 19 french, and a 20-degree cystoscope was introduced.The cystoscope was then removed, the bladder was drained, and the patient was awakened from sedation and transferred to recovery in stable condition.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway IN H91 C 2NF; EI H91 C2NF
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20466730
• Report Number: 2124215-2024-63430
• Device Sequence Number: 17984210
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)200531(10)C003461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 05/31/2020
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C003461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 10/13/2025; 04/17/2026
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/14/2025; 11/11/2025; 05/15/2026
• Date Device Manufactured: 05/19/2017
• 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: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female