MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502000

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block 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.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Mesh excision surgery at: (b)(6) hospital.Block h6: imdrf patient codes e0206: mental pain, e2330: pain, e1310: urinary tract infection, e1002: abdominal pain, e0123: nerve damage, e1401: vaginal discharge, e2326: inflammation, e2401: severe adverse reactions, and e1309: inability to urinate.Imdrf impact codes f1905, f1204, and f1901 capture the reportable events of device revision, permanent impairment, and additional surgeries.

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on (b)(6) 2020, for the treatment of stress incontinence.As reported by the patient's attorney, the patient postoperatively began to experience severe complications related to the implanted advantage system including but not limited to; inability to urinate, chronic urinary tract infections, vaginal discharge, and severe stomach pain.On or around (b)(6) 2021, the patient underwent excision of exposed sling mesh, transection of sling, and cystoscopy due to exposure of vaginal mesh through the vaginal wall.As a direct and proximate result of device implant procedure, patient had experienced significant mental and physical pain and suffering, had sustained permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures, including, but not limited to, obligations for medical services and expenses, and other damages.Additionally, the patient had suffered inflammation of the pelvic tissue and severe adverse reactions to the mesh.The patient underwent operations to locate and remove the mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on (b)(6) 2020, for the treatment of stress incontinence.As reported by the patient's attorney, the patient postoperatively began to experience severe complications related to the implanted advantage system including but not limited to; inability to urinate, chronic urinary tract infections, vaginal discharge, and severe stomach pain.On or around (b)(6) 2021, the patient underwent excision of exposed sling mesh, transection of sling, and cystoscopy due to exposure of vaginal mesh through the vaginal wall.As a direct and proximate result of device implant procedure, patient had experienced significant mental and physical pain and suffering, had sustained permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures, including, but not limited to, obligations for medical services and expenses, and other damages.Additionally, the patient had suffered inflammation of the pelvic tissue and severe adverse reactions to the mesh.The patient underwent operations to locate and remove the mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block 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.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Mesh excision surgery at: (b)(6).Block h6: imdrf patient codes e0206: mental pain, e2330: pain, e1310: urinary tract infection, e1002: abdominal pain, e0123: nerve damage, e1401: vaginal discharge, e2326: inflammation, e2401: severe adverse reactions, and e1309: inability to urinate.Imdrf impact codes f1905, f1204, and f1901 capture the reportable events of device revision, permanent impairment, and additional surgeries.Block h11: block h6 evaluation conclusion code has been corrected.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Implant physician name: dr.(b)(6).Mesh excision surgery at: (b)(6) hospital.(b)(6).Block h6: imdrf patient codes e0206: mental pain, e2330: pain, e1310: urinary tract infection, e1002: abdominal pain, e0123: nerve damage, e1401: vaginal discharge, e2326: inflammation, e2401: severe adverse reactions, and e1309: inability to urinate.Imdrf impact codes f1905, f1204, and f1901 capture the reportable events of device revision, permanent impairment, and additional surgeries.Block h10: correction to field block d4: model number, lot number, expiration date, model number/catalog number, and unique identifier (udi) #.Correction to field block e1: initial reporter address 1.Correction to field block g1: manufacturer contact person.Updated block h10 (block e1 with physician's information).

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on (b)(6) 2020, for the treatment of stress incontinence.As reported by the patient's attorney, the patient postoperatively began to experience severe complications related to the implanted advantage system including but not limited to; inability to urinate, chronic urinary tract infections, vaginal discharge, and severe stomach pain.On or around (b)(6) 2021, the patient underwent excision of exposed sling mesh, transection of sling, and cystoscopy due to exposure of vaginal mesh through the vaginal wall.As a direct and proximate result of device implant procedure, patient had experienced significant mental and physical pain and suffering, had sustained permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures, including, but not limited to, obligations for medical services and expenses, and other damages.Additionally, the patient had suffered inflammation of the pelvic tissue and severe adverse reactions to the mesh.The patient underwent operations to locate and remove the mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.

Event Description

It was reported to boston scientific corporation that an advantage system was implanted into the patient during a procedure performed on december 2, 2020, for the treatment of stress incontinence.As reported by the patient's attorney, the patient postoperatively began to experience severe complications related to the implanted advantage system including but not limited to; inability to urinate, chronic urinary tract infections, vaginal discharge, and severe stomach pain.On or around august 11, 2021, the patient underwent excision of exposed sling mesh, transection of sling, and cystoscopy due to exposure of vaginal mesh through the vaginal wall.As a direct and proximate result of device implant procedure, patient had experienced significant mental and physical pain and suffering, had sustained permanent injury, had undergone medical treatment and will likely undergo further medical treatment and procedures, including, but not limited to, obligations for medical services and expenses, and other damages.Additionally, the patient had suffered inflammation of the pelvic tissue and severe adverse reactions to the mesh.The patient underwent operations to locate and remove the mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine, and the vagina, and operations to remove portions of the female genitalia.***additional information received on january 3, 2024*** on december 2, 2020, the patient had cystoscopy, right retrograde pyelography with fluoroscopy, right ureteroscopy, laser lithotripsy, stone extraction and insertion of indwelling double-j stent, transvaginal sling, and advantage.It was reported that the sling kit was opened and used trocar at the right half of the sling and was then placed on the trocar through the previously dissected area.The trocar remained in place, and cystoscopy took place with a 30 and 70-degree lens.There was no evidence of ureteral injury.There was no evidence of bladder injury.The sling was brought through.This was repeated on the patient's left.The sling was then tensioned against the curved crile and the sheaths were removed.The area was irrigated with gu irrigant.The incision was then closed with 2-0 vicryl suture in a figure-of-eight fashion.The sling arms were then cut below the level of the skin bilaterally and the skin was closed with a 4-0 monocryl.The patient was awakened and taken to the recovery room in good condition.The patient was advised not to lift anything greater than 15 pounds for 6 weeks.On august 11, 2021, the patient underwent an excision of the exposed sling mesh, transection of the sling, and cystoscopy was performed due to exposure of vaginal mesh through the vaginal wall and initial encounter voiding dysfunction.The exposed edge of mesh was grasped with a tonsil and anterior epithelium was incised in the midline for approximately 2-3 cm.The overlying vaginal epithelium off the underlying tissues and reflected laterally bilaterally.Using a combination of blunt dissection (was dissected with 1 q-tips and freer), and sharp dissection, the sling was exposed for presumably the entire cross-section.It seemed narrower than anticipated, but the distal edge was folded.Two tonsils were utilized to grasp the distal edge of the mesh and the mesh was able to be transected with immediate separation, palpation did not reveal any remaining identifiable mesh, and given the separation, seemed to be transected completely.The distal portion of each side of the mesh was then excised equivalent to the amount of the exposure.Given the degree of separation with transection, the remaining mesh edges retracted and were not palpable.The patient had dilated vasculature along her left periurethral tissues.Irrigation was performed.The epithelium was then closed in a series of interrupted and figure of 8 3-0 vicryl sutures.A cystoscopy was performed with findings (eua with exposure of distal edge sling on the patient's left, cystoscopy with absence of bladder trauma, and presence of bilateral jets of pyridium stained urine.Incredibly atrophic tissues).Vaginal packing was not placed given concerns about the friability of her tissues.She was then returned supine, counts were correct, and anesthesia was reversed.The patient was taken to post anesthesia care unit (pacu) in stable condition.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Mesh excision surgery at: (b)(6).Block h6: imdrf patient codes e0206: mental pain, e2330: pain, e1310: urinary tract infection, e1002: abdominal pain, e0123: nerve damage, e1401: vaginal discharge, e2326: inflammation, e2401: severe adverse reactions, and e1309: inability to urinate.Imdrf impact codes f1905, f1204, and f1901 capture the reportable events of device revision, permanent impairment, and additional surgeries.

• Brand Name: ADVANTAGE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17660517
• MDR Text Key: 322371775
• Report Number: 3005099803-2023-04611
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0025948870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 11/29/2023; 01/03/2024
• Supplement Dates FDA Received: 09/25/2023; 12/27/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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
• Patient Age: 57 YR
• Patient Sex: Female