MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number	830-243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Prolapse (2475); Weight Changes (2607); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	10/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016, was chosen as a best estimate based on the date the mesh was implanted.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pelvic pain, e0506 - bleeding, e1906 - infection.The following imdrf impact codes capture the reportable events of: f1903 - vaginal mesh excision, f1202 - disability, f2301 - additional device required, f08 - hospitalization prolonged hospitalization, f1901 - additional surgery, f1001 - procedure cancelled.
Event or Problem Description
It was reported that, sometime after a hysterectomy, the patient developed bladder prolapse.Upon review of her medical records, there was no indication that bladder support had been performed, and she was misdiagnosed with genital herpes.The physician had since relocated, which made follow-up became impossible, and the referring nurse practitioner provided no viable solutions.The patient reported the response to her distress was dismissive, and she left the office emotionally shaken and unsupported.She was referred to a urogynecologist, and after a six-week wait, she underwent a surgical procedure in (b)(6) 2016.During this surgery, a xenform mesh was implanted.It was noted that the surgery was ineffective.Before she could completely recover, her bladder prolapsed again.Subsequently, she learned that her bladder was not lifted at all, instead, the physician lifted her rectum, in an attempt to indirectly support the bladder.After five months and six-weeks-post-operation recovery, another surgery was scheduled.In (b)(6) 2017, the patient noted tissue falling through her vagina again.During her follow-up examination, no abnormality was found; however, she was instructed to take a photo of her vagina when she felt the protrusion, which ultimately confirmed her concerns.Another surgery followed, and the patient experienced prolonged pain, hospital stays, has had frequent shots of morphine administered for postoperative care, and went home with pain medications.On (b)(6) 2021, she was rushed to a hospital with the diagnosis of a rare spinal infection-- described as sack of pus adhered her spine and diseased part of her spinal column.Recovery was grueling, involving long-term iv antibiotics and significant weight loss due to malnutrition.She remained physically compromised--unable to perform basic movements or return to previous activities like yoga.In (b)(6) 2022, her rectum began to prolapse.Often times she bled whenever her bowels would move.The constant rubbing of clothing against here anal sphincter was near impossible to prevent her condition; instead, it continues to worsen.She cannot sit or walk comfortably.Due to her numerous surgeries, her pelvic region has been filled with bacteria trapped by scar tissue.In (b)(6) 2023, she underwent another surgery which was partially successful.However, sometime after the procedure, residual mesh fragments have been found-- small pieces were still attached to the bladder and buried deep in her vagina.She was scheduled for another procedure, with a three-month recovery period.The scheduled procedure had to be aborted due to its complexity, requiring hospital facilities.It was noted that the patient had been anesthetized by time the procedure was cancelled.To prevent her urethra from attaching itself to her bladder, a short stent was inserted.She was on a catheter for 15 days and was back in the hospital after 30-days for stent removal.Eventually, the mesh was completely excised; however, up to this day, her bladder still has been prolapsing and attempting to lift her tissue may risks creating a fistula.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016, was chosen as a best estimate based on the date the mesh was implanted.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pelvic pain e0506 - bleeding e1906 - infection the following imdrf impact codes capture the reportable events of: f1903 - vaginal mesh excision f1202 - disability f2301 - additional device required f08 - hospitalization prolonged hospitalization f1901 - additional surgery block h11: correction to field h6: impact code.
Event or Problem Description
It was reported that, sometime after a hysterectomy, the patient developed bladder prolapse.Upon review of her medical records, there was no indication that bladder support had been performed, and she was misdiagnosed with genital herpes.The physician had since relocated, which made follow-up became impossible, and the referring nurse practitioner provided no viable solutions.The patient reported the response to her distress was dismissive, and she left the office emotionally shaken and unsupported.She was referred to a urogynecologist, and after a six-week wait, she underwent a surgical procedure in (b)(6) 2016.During this surgery, a xenform mesh was implanted.It was noted that the surgery was ineffective.Before she could completely recover, her bladder prolapsed again.Subsequently, she learned that her bladder was not lifted at all, instead, the physician lifted her rectum, in an attempt to indirectly support the bladder.After five months and six-weeks-post-operation recovery, another surgery was scheduled.In (b)(6) 2017, the patient noted tissue falling through her vagina again.During her follow-up examination, no abnormality was found; however, she was instructed to take a photo of her vagina when she felt the protrusion, which ultimately confirmed her concerns.Another surgery followed, and the patient experienced prolonged pain, hospital stays, has had frequent shots of morphine administered for postoperative care, and went home with pain medications.On (b)(6) 2021, she was rushed to a hospital with the diagnosis of a rare spinal infection-- described as sack of pus adhered her spine and diseased part of her spinal column.Recovery was grueling, involving long-term iv antibiotics and significant weight loss due to malnutrition.She remained physically compromised--unable to perform basic movements or return to previous activities like yoga.In (b)(6) 2022, her rectum began to prolapse.Often times she bled whenever her bowels would move.The constant rubbing of clothing against here anal sphincter was near impossible to prevent her condition; instead, it continues to worsen.She cannot sit or walk comfortably.Due to her numerous surgeries, her pelvic region has been filled with bacteria trapped by scar tissue.In (b)(6) 2023, she underwent another surgery which was partially successful.However, sometime after the procedure, residual mesh fragments have been found-- small pieces were still attached to the bladder and buried deep in her vagina.She was scheduled for another procedure, with a three-month recovery period.The scheduled procedure had to be aborted due to its complexity, requiring hospital facilities.It was noted that the patient had been anesthetized by time the procedure was cancelled.To prevent her urethra from attaching itself to her bladder, a short stent was inserted.She was on a catheter for 15 days and was back in the hospital after 30-days for stent removal.Eventually, the mesh was completely excised; however, up to this day, her bladder still has been prolapsing and attempting to lift her tissue may risks creating a fistula.

• Brand Name: XENFORM
• Common Device Name: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): INTEGRA LIFE SCIENCES SALES LLC; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22101308
• Report Number: 2124215-2025-32939
• Device Sequence Number: 17980933
• Product Code: FTM
• UDI-Device Identifier: 08714729774464
• UDI-Public: (01)08714729774464(17)190331(10)1611033
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 03/31/2019
• Device Model Number: 830-243
• Device Catalogue Number: 830-243
• Device Lot Number: 0001611033
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 12/09/2016
• 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; Hospitalization; Disability; Other
• Patient Sex: Female