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

Model Number M0068402400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Prolapse (2475); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Insufficient Information (4580)

Event Date 08/27/2008

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-02860 for the associated device.It was reported to boston scientific corporation that an advantage system and polyform graft device were implanted into the patient during a procedure performed on (b)(6) 2008, for the treatment of stress urinary incontinence and second-degree pelvic organ prolapse.According to the report, there were no intraoperative complications during the surgery.The patient has suffered significant mental and physical pain and suffering as a result of the advantage sling and polyform graft, sustained permanent injury and a permanent and substantial physical deformity, will most likely continue to undergo corrective surgeries, and has suffered financial or economic loss, including but not limited to obligations for medical services and expenses.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2008, was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the complainant was unable to provide the suspect device and upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting facility is: medical center (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2330 - used to capture the reported event of physical pain and suffering.E0206- used to capture the reported event of mental pain.E2308 - used to capture the reported event of substantial physical deformity.The following imdrf impact codes capture the reportable event of: f1202: disability - used to capture the reported event of the patient sustained permanent injury.F19: surgical intervention - used to capture the reported event of patient will likely to continue to undergo corrective surgery.

Event Description

Note: this manufacturer report pertains to one of the two devices used during the same procedure.Please refer to manufacturer report 3005099803-2023-02860 for the associated device.It was reported to boston scientific corporation that an advantage system and polyform graft devices were implanted into the patient during a procedure performed on (b)(6) 2008, for the treatment of stress urinary incontinence and second-degree pelvic organ prolapse.According to the report, there were no intraoperative complications during the surgery.The patient has suffered significant mental and physical pain and suffering as a result of the advantage sling and polyform graft, sustained permanent injury and a permanent and substantial physical deformity, will most likely continue to undergo corrective surgeries, and has suffered financial or economic loss, including but not limited to obligations for medical services and expenses.Additional information received on november 27, 2023.The following physical ailments were reported by the patient: pain, pelvic pain, scarring, bleeding, dyspareunia, infections, urinary problems, erosion, extrusion, recurrence, neuromuscular problems, and mesh removal surgery.Additionally, it was noted that the patient's present complaints were exposed mesh, vaginal pain, pelvic pain, dyspareunia, and urinary problems (unable to determine when to urinate).On (b)(6) 2019, perineorrhaphy, posterior vaginal wall revision, and vaginal mesh removal were performed on the patient due to vaginal mesh prolapse.Findings also showed exposure of vaginal mesh.On (b)(6) 2020, the patient underwent posterior vaginal mesh removal, posterior vaginal wall plication, and labiaplasty as she was diagnosed with erosion of posterior vaginal mesh and redundant labia minora.

Manufacturer Narrative

Blocks d4: model number, e1 below, g1: manufacturing site, h6: patient codes and impact codes have been updated based on the additional information received on november 27, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2008, was chosen as a best estimate based on the date the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeons are: dr.(b)(6), (b)(6) hospital, (b)(6).Revision and removal surgeon: dr.(b)(6), (b)(6) hospital, (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2006: erosion and extrusion.E2330: pain.E1405: dyspareunia.E1906: infection.E1715: scarring.E2401: neuromuscular problems.E1311: urinary problems.E2308: physical deformity.E0206: unspecified mental, emotional or behavioural problem.The following imdrf impact codes capture the reportable event of: f1202: disability.F19: surgical intervention.F1903: device explantation.

• Brand Name: POLYFORM SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL; coilleach; spiddal, co galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17114818
• MDR Text Key: 317029767
• Report Number: 3005099803-2023-02861
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068402400
• Device Catalogue Number: 840-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 73 KG