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

Model Number M0068502050

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Purulent Discharge (1812); Fistula (1862); Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Anxiety (2328); Depression (2361); Prolapse (2475); Hematuria (2558); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 07/16/2009

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009 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 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 physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e232402 - urinary incontinence e0206 - loss of enjoyment of life and loss of spouse e2330 - pelvic pain, back pain, hip pain and leg pain e0123 - nerve damage e1304 - urinary urgency e1405 - dyspareunia e020201 - anxiety e020202 - depression e1906 - infection e2006 - erosion the following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.F1202 - permanent physical injury.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a procedure performed on (b)(6) 2009.As a result of the implantation of the prior designated pelvic mesh product, the patient claims to have suffered the following injuries: infections, pelvic pain, back pain, hip pain, leg pain, nerve damage, prolapse, failed sling, dyspareunia, stress and urge incontinence, mesh erosion, loss of a spouse, and more to be determined during the course of discovery.Furthermore, the patient claims to have suffered the following damages as a result of the prior designated pelvic mesh product's implantation: economic damages such as medical bills, out-of-pocket expenses, and lost wages; as well as non-economic damages such as pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, and permanent physical injury.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of july 16, 2009 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 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 physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e232402 - urinary incontinence e0206 - loss of enjoyment of life and loss of spouse e2330 - pelvic pain, back pain, hip pain and leg pain e0123 - nerve damage e1304 - urinary urgency e1405 - dyspareunia e020201 - anxiety e020202 - depression e1906 - infection e2006 - erosion the following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.F1202 - permanent physical injury.Block h11: blocks a1, a2, b5, h2, h6 (component code, evaluation method code, evaluation result code, evaluation conclusion code), and h10 have been updated based on the additional information received on june 27, 2023.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during a procedure performed on (b)(6) 2009.As a result of the implantation of the prior designated pelvic mesh product, the patient claims to have suffered the following injuries: infections, pelvic pain, back pain, hip pain, leg pain, nerve damage, prolapse, failed sling, dyspareunia, stress and urge incontinence, mesh erosion, loss of a spouse, and more to be determined during the course of discovery.Furthermore, the patient claims to have suffered the following damages as a result of the prior designated pelvic mesh product's implantation: economic damages such as medical bills, out-of-pocket expenses, and lost wages; as well as non-economic damages such as pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, and permanent physical injury.Pre-operatively the patient was diagnosed with menorrhagia and genuine stress urinary incontinence for the tension-free vaginal tape through transobturator space, cystoscopy, dilation and curettage, hysterectomy, and endometrial ablation procedures performed on (b)(6) 2009.Findings include a uterus that sounded to be about 9.0 cm.A moderate amount of endometrial tissue was noted with normal cystoscopy.The patient was then taken to the recovery room in stable condition.

Manufacturer Narrative

Blocks b2, b5, b7 and h6 patient codes and impact codes have been updated due to additional information received on october 10, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009, 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 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 physician is: dr.(b)(6).Revision surgeon physician: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e232402 - urinary incontinence e0206 - loss of enjoyment of life and loss of spouse e2330 - pelvic pain, back pain, hip pain and leg pain e0123 - nerve damage e1304 - urinary urgency e1405 - dyspareunia e020201 - anxiety e020202 - depression e1906 - infection e2006 - erosion e2314 - fistula e2015 - atrophy e1310 - infection, urinary tract e2326 - inflammation e1302 - hematuria e0505 - hematoma (removed clot).The following imdrf impact code capture the reportable event of: f1202 - permanent physical injury f1905: device revision/replacement.

Event Description

It was reported to boston scientific corporation that an advantage blue system device was implanted into the patient during a procedure performed on (b)(6) 2009.As a result of the implantation of the prior designated pelvic mesh product, the patient claims to have suffered the following injuries: infections, pelvic pain, back pain, hip pain, leg pain, nerve damage, prolapse, failed sling, dyspareunia, stress and urge incontinence, mesh erosion, loss of a spouse, and more to be determined during the course of discovery.Furthermore, the patient claims to have suffered the following damages as a result of the prior designated pelvic mesh product's implantation: economic damages such as medical bills, out-of-pocket expenses, and lost wages; as well as non-economic damages such as pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment, and permanent physical injury.Additional information received on june 27, 2023: pre-operatively the patient was diagnosed with menorrhagia and genuine stress urinary incontinence for the tension-free vaginal tape through transobturator space, cystoscopy, dilation and curettage, hysterectomy, and endometrial ablation procedures performed on (b)(6) 2009.Findings include a uterus that sounded to be about 9.0 cm.A moderate amount of endometrial tissue was noted with normal cystoscopy.The patient was then taken to the recovery room in stable condition.Additional information received on october 10, 2023: in a clinical note of (b)(6) 2022, it was stated that the patient had worsening incontinence and feeling of vaginal discharge and mesh erosion.Leakage and discharge had been present for years.Patient also had multiple treatments for utis over the last several years.Leaking urine throughout the day, dribbling and sometimes without sensation.Also leaked with urges.Has not responded to medications or kegel exercises.Had not used any vaginal estrogen.No prior physical therapy.Limited sexual activity due to discomfort.She was a current smoker and not diabetic.Review of systems included occasional pain in the left groin, genital discharge, bleeding, and leakage.Physical exam resulted large exposure of mesh midline to left lateral sulcus, very tender; atrophic mucosa, inflamed mucosa, discharge, and foul odor; some leakage of urine from the erosion area as it is very distal at the urethra.Stage 1-2 cystocele with mobility.Positive for incontinence with cough supine, leaking through the mesh erosion.Urinalysis showed leukocytes and blood.Assessment: patient had severe vaginal mesh exposure and pain, recurrent urinary incontinence and possible erosion with fistula, vaginitis, recurrent uti.Given the severity of her mesh erosion and possibility of urethrovaginal fistula formation with the erosion, it was suggested that the patient should undergo surgical excision of the exposed mesh and any visible mesh.Would then plan for urethral reconstruction and vaginal reconstruction.Planned for excision of sling mesh, possible anterior repair, cystoscopy, possible urethral reconstruction.Would need postoperative catheterization likely 1 week.The patient underwent a revision surgery on the dame date, (b)(6) 2023.She had revision of tension free vaginal taping, vaginal mesh erosion repair, and cystoscopy due to refractory mesh in vagina with recurrent uti and vaginal discharge, urinary incontinence.On exam under anesthesia, the mesh was eroded into the urethra at the bladder neck on the right and the left arm of the mesh was going through the vaginal epithelium into the retropubic space.Exam under anesthesia demonstrated the large mesh erosion of 3cm exposed mesh with calcification and with valsalva there was urine leaking around the mesh.After adequate exposure obtained, mesh was grasped and excised using sharp and blunt technique after it was cut in the middle.The excised mesh was sent to pathology.The surgeon was able to undermine the epithelium and identify the large 1cm fistula communication.Per cystoscopy, clot was also removed from the area.The repair was watertight and no leaking from the tract was noted.There were no complications reported after the procedure.The patient was transferred to the recovery room in stable condition.

• Brand Name: ADVANTAGE BLUE 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: 16813065
• MDR Text Key: 313989002
• Report Number: 3005099803-2023-02054
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961918
• UDI-Public: 08714729961918
• 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
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502050
• Device Catalogue Number: 850-205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female