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

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 12/18/2018

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence, cystocele and rectocele.After the procedure, the patient has experienced extreme pain, discomfort, urinary problems, dyspareunia and other injuries.On (b)(6) 2020, the patient underwent a cystourethroscopy, robotic assisted laparoscopic resection, cystectomy and resection of eroded mesh within the bladder and bladder wall.During the surgery, presence of eroded mesh was confirmed and a segment of 1-2 cm of polypropylene mesh was extruding from the inferior lateral aspect of the bladder on the patient's right side.Additionally, there was a severe puckering and distortion of the urothelium superior to the trigone.To date, the patient continues to have urinary issues, such as difficulties with urinary incontinence while working and walking.Reportedly, the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury.The patient has also suffered a loss of earnings and earning capacity.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date of the mesh removal surgery.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence, cystocele and rectocele.After the procedure, the patient has experienced extreme pain, discomfort, urinary problems, dyspareunia and other injuries.On (b)(6) 2020, the patient underwent a cystourethroscopy, robotic assisted laparoscopic resection, cystectomy and resection of eroded mesh within the bladder and bladder wall.During the surgery, presence of eroded mesh was confirmed and a segment of 1-2 cm of polypropylene mesh was extruding from the inferior lateral aspect of the bladder on the patient's right side.Additionally, there was a severe puckering and distortion of the urothelium superior to the trigone.To date, the patient continues to have urinary issues, such as difficulties with urinary incontinence while working and walking.Reportedly, the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury.The patient has also suffered a loss of earnings and earning capacity.Boston scientific received an additional information on july 27, 2022 as follows: it was reported to boston scientific corporation that a lynx system device was implanted into the patient during a lynx sling cystourethropexy and cystourethroscopy procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence, cystocele and rectocele.Reportedly, the patient was taken to the recovery room in a stable condition.After the procedure, the patient visited the clinic on (b)(6) 2020, as a follow-up from urgent care for a possible urinary tract infection.She claims that a week before to her consultation, she first had dysuria, gross hematuria, urinary urgency, and frequency.She did go to the urgent care center, where she was given pyridium and antibiotics.In addition, the patient began a trial of myrbetriq 25 mg daily for her urgency and frequency complaints.On (b)(6) 2020, the patient's urine urgency, frequency, and dysuria persisted, necessitating a cystourethroscopy.A vaginal exam revealed a normal midline urethral meatus, no vaginal vault lesions, and the patient wore a nuvaring.There were no carbuncles, erythema, or discharge.There is no tenderness in the urethra at the meatus or along its length.There was no tenderness at the bladder neck.No masses or extrusion of mesh was appreciated.The scope entered into the bladder, and the surgeon instantly noted a calcification of over 1 centimeter extending into the bladder from the bladder neck at the 11 o'clock position.No other lesions were identified, and no mesh extruded on the left side of the bladder.There were no clots within the bladder.On (b)(6) 2020, the patient had a cystourethroscopy and laser cystolitholapaxy for treatment of bladder stone.A rigid cystoscope was reportedly utilized during the procedure to get access to the bladder, and it revealed a normal midline urethral meatus.Once inside the bladder, at the 11 o'clock position, the surgeon detected a large stone, which had earlier been seen on flexible cystourethroscopy.Furthermore, utilizing 800 micro fiber, they were able to laser all of the stone fragments off of the exposed mesh running along the superior lateral portion of the bladder.All of the stone pieces were lysed into small bits which were then extruded through vacuum extraction out of the bladder.A few stone fragments were sent off as specimens.The distal edge of the mesh was then lasered in an air pocket, causing the mesh material to melt from the tip of the laser fiber, and the more proximal edge was also melted away.Mesh fibers remained at the mucosal level.Along with the stones, the mesh was removed.With minimal bleeding, the bladder was refilled and drained multiple times.It was observed that no stone particles remained in place.The patient was awakened by anesthesia and taken to the recovery room in stable condition.In addition, the patient will return in 3 weeks and they will discuss the further treatment of that small section of the bladder, perhaps utilizing a green-light laser to melt the remaining portion of the mesh fragments.The patient returned to the clinic on (b)(6) 2020, for a post operative visit.The patient stated that while there is now less urgency, there is still occasional bleeding.She has no chills or fever, but she does have mild to moderate pain throughout her suprapubic area and continues to have urgent urination every hour.No leaking urine and constipation was observed.The physician prescribed overactive bladder medication, oxybutin chloride 10mg 1 by mouth daily, and advised the patient to consult with her gynecologist about the likelihood of needing revision and resection.The patient was visited for a urogynecological consultation on (b)(6) 2020.Her urologist recommended her for an examination and treatment of bladder mesh erosion.The patient describes having intermittent dysuria, dyspareunia since her sling procedure, bladder pain, urine urgency, frequency, and incomplete bladder emptying as ongoing symptoms since her mid urethral sling procedure.She rejects any claims of persistent stress incontinence, pelvic floor herniation symptoms, or defecatory dysfunction.She had a saline hysterosonography in august 2020, and the results point to an underlying adenomyosis.Per the review of systems, the patient was positive for the following: * difficulty urinating * dyspareunia * dysuria * frequency * hematuria * menstrual problem * pelvic pain * vaginal bleeding * vaginal pain on (b)(6) 2020, the patient underwent a cystourethroscopy.Cystoscopy found a 2 cm length of polypropylene mesh extruding through the right lateral bladder wall.Moreover, a puckering erythematous area of retracted urothelium created a 1 cm pocket/deformation approximately 4 cm cephalad at the trigonal ridge on the right side was observed.The remainder of the bladder urothelium was normal throughout.The trigone was markedly normal, with a minor amount of benign-appearing squamous metaplasia.Both ureteral orifices were in their typical anatomic position, with notable urine outflow.Urethral vesicle connection, mucosa, and lumen are all normal.There was no sign of urethral diverticulum, exudate, fine mesh, or other pathology.On (b)(6) 2021, the patient underwent a cystourethroscopy, robotic assisted laparoscopic resection, cystectomy and resection of eroded mesh within the bladder and bladder wall.Examination under anesthesia demonstrated no evidence of transvaginal mesh erosion.There were no adnexal or pelvic masses appreciated.The cystoscopy findings included a 1-2 cm segment of the polypropylene mesh that had eroded into the bladder localized to the patient's right superolateral inferior aspect of the bladder as well as an area of significant puckering and distortion of the bladder wall and urothelium, also on the right side superior to the trigone and just to the right of midline.No significant pelvic pathology observed.The patient was subsequently awakened and transferred to recovery room in stable condition.There were no observed complications.Blood loss was minimal and she appeared to tolerate the procedure very well.The patient was seen for a post operative visit on (b)(6) 2021.The physician reported that the patient's perioperative course has been uncomplicated and her only complaint was relate to bladder spasms.

Manufacturer Narrative

Block h2: additional information block b5 narrative updated block a2 date of birth updated block b7 other relevant history updated block d6b explant date updated block d7a reprocessed and reused updated block h6 patient and impact code updated correction: block b3 date of event updated block g2 report source updated block b3 date of event: the exact event onset date is unknown.The provided event date of december 18, 2018, 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 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 implant surgeon is: (b)(6) center, llc, asc united states (b)(6), asc united states the explant surgeon is: dr.Richard ellerkmann the weinberg center for women's health and medicine at lutherville 1734 york road, lutherville, md united states 21093-5606 block h6: patient codes e1405, e020201, e2319, e1301, e1906, e1309, e1310, e2326, e2401, e1302, e2006, e230901, e2308, e2328, e2330 capture the reportable events of dyspareunia, anxiety, hernia, dysuria, infection, urinary retention, inflammation, hematuria, erosion, calcification, bladder stone, pain and adenomyosis.Impact codes f1901, f1903, f1202, f1204, f2303 capture the reportable events permanent injury, resection of eroded mesh, cystectomy and medications required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h2: correction.Block b5 narrative corrected.Block h6 patient codes corrected, e1715 scar tissue, e2338 swelling/edema and e1605 muscle spasm have been added.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, 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 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 implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6: patient codes e1405, e1715, e1301, e2338, e1906, e1309, e1310, e2326, e2401, e1302, e2006, e230901, e2308, e2328, e2330 capture the reportable events of dyspareunia, scar tissue, dysuria, swelling/edema, infection, urinary retention, inflammation, hematuria, erosion, calcification, bladder stone, pain and adenomyosis.Impact codes f1901, f1903, f1202, f1204, f2303 capture the reportable events permanent injury, resection of eroded mesh, cystectomy and medications required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence, cystocele and rectocele.After the procedure, the patient has experienced extreme pain, discomfort, urinary problems, dyspareunia and other injuries.On (b)(6) 2020, the patient underwent a cystourethroscopy, robotic assisted laparoscopic resection, cystectomy and resection of eroded mesh within the bladder and bladder wall.During the surgery, presence of eroded mesh was confirmed and a segment of 1-2 cm of polypropylene mesh was extruding from the inferior lateral aspect of the bladder on the patient's right side.Additionally, there was a severe puckering and distortion of the urothelium superior to the trigone.To date, the patient continues to have urinary issues, such as difficulties with urinary incontinence while working and walking.Reportedly, the patient has experienced significant mental and physical pain and suffering and has sustained permanent injury.The patient has also suffered a loss of earnings and earning capacity.Boston scientific received an additional information on july 27, 2022 as follows: it was reported to boston scientific corporation that a lynx system device was implanted into the patient during a lynx sling cystourethropexy and cystourethroscopy procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence, cystocele and rectocele.Reportedly, the patient was taken to the recovery room in a stable condition.After the procedure, the patient visited the clinic on (b)(6) 2020, as a follow-up from urgent care for a possible urinary tract infection.She claims that a week before to her consultation, she first had dysuria, gross hematuria, urinary urgency, and frequency.She did go to the urgent care center, where she was given pyridium and antibiotics.In addition, the patient began a trial of myrbetriq 25 mg daily for her urgency and frequency complaints.On (b)(6) 2020, the patient's urine urgency, frequency, and dysuria persisted, necessitating a cystourethroscopy.A vaginal exam revealed a normal midline urethral meatus, no vaginal vault lesions, and the patient wore a nuvaring.There were no carbuncles, erythema, or discharge.There is no tenderness in the urethra at the meatus or along its length.There was no tenderness at the bladder neck.No masses or extrusion of mesh was appreciated.The scope entered into the bladder, and the surgeon instantly noted a calcification of over 1 centimeter extending into the bladder from the bladder neck at the 11 o'clock position.No other lesions were identified, and no mesh extruded on the left side of the bladder.There were no clots within the bladder.On (b)(6) 2020, the patient had a cystourethroscopy and laser cystolitholapaxy for treatment of bladder stone.A rigid cystoscope was reportedly utilized during the procedure to get access to the bladder, and it revealed a normal midline urethral meatus.Once inside the bladder, at the 11 o'clock position, the surgeon detected a large stone, which had earlier been seen on flexible cystourethroscopy.Furthermore, utilizing 800 micro fiber, they were able to laser all of the stone fragments off of the exposed mesh running along the superior lateral portion of the bladder.All of the stone pieces were lysed into small bits which were then extruded through vacuum extraction out of the bladder.A few stone fragments were sent off as specimens.The distal edge of the mesh was then lasered in an air pocket, causing the mesh material to melt from the tip of the laser fiber, and the more proximal edge was also melted away.Mesh fibers remained at the mucosal level.Along with the stones, the mesh was removed.With minimal bleeding, the bladder was refilled and drained multiple times.It was observed that no stone particles remained in place.The patient was awakened by anesthesia and taken to the recovery room in stable condition.In addition, the patient will return in 3 weeks and they will discuss the further treatment of that small section of the bladder, perhaps utilizing a green-light laser to melt the remaining portion of the mesh fragments.The patient returned to the clinic on (b)(6) 2020, for a post operative visit.The patient stated that while there is now less urgency, there is still occasional bleeding.She has no chills or fever, but she does have mild to moderate pain throughout her suprapubic area and continues to have urgent urination every hour.No leaking urine and constipation was observed.The physician prescribed overactive bladder medication, oxybutin chloride 10mg 1 by mouth daily, and advised the patient to consult with her gynecologist about the likelihood of needing revision and resection.The patient was visited for a urogynecological consultation on (b)(6) 2020.Her urologist recommended her for an examination and treatment of bladder mesh erosion.The patient describes having intermittent dysuria, dyspareunia since her sling procedure, bladder pain, urine urgency, frequency, and incomplete bladder emptying as ongoing symptoms since her mid urethral sling procedure.She rejects any claims of persistent stress incontinence, pelvic floor herniation symptoms, or defecatory dysfunction.She had a saline hysterosonography in august 2020, and the results point to an underlying adenomyosis.Per the review of systems, the patient was positive for the following: difficulty urinating.Dyspareunia.Dysuria.Frequency.Hematuria.Menstrual problem.Pelvic pain.Vaginal bleeding.Vaginal pain.On (b)(6), 2020, the patient underwent a cystourethroscopy.Cystoscopy found a 2 cm length of polypropylene mesh extruding through the right lateral bladder wall.Moreover, a puckering erythematous area of retracted urothelium created a 1 cm pocket/deformation approximately 4 cm cephalad at the trigonal ridge on the right side was observed.The remainder of the bladder urothelium was normal throughout.The trigone was markedly normal, with a minor amount of benign-appearing squamous metaplasia.Both ureteral orifices were in their typical anatomic position, with notable urine outflow.Urethral vesicle connection, mucosa, and lumen are all normal.There was no sign of urethral diverticulum, exudate, fine mesh, or other pathology.On (b)(6) 2021, the patient underwent a cystourethroscopy, robotic assisted laparoscopic resection, cystectomy and resection of eroded mesh within the bladder and bladder wall.Examination under anesthesia demonstrated no evidence of transvaginal mesh erosion.There were no adnexal or pelvic masses appreciated.The cystoscopy findings included a 1-2 cm segment of the polypropylene mesh that had eroded into the bladder localized to the patient's right superolateral inferior aspect of the bladder as well as an area of significant puckering and distortion of the bladder wall and urothelium, also on the right side superior to the trigone and just to the right of midline.No significant pelvic pathology observed.Examination of the surrounding mucosa both cystoscopically and laparoscopically showed some edema and chronic inflammation from the eroded mesh.The edges were subsequently sharply trimmed with minimal cautery to essentially freshen them prior to repairing the cystotomy in 2 layers, 1st including the mucosa with a 3-0 vicryl suture in a running fashion followed by a 2nd layer of the muscularis overlying the 1st closure with 2-0 vicryl suture in a running fashion.Once this area was repaired, the more posterior aspect of the mesh which had been noted with dissection of the space of retzius was observed to be encased in scar tissue.This was transected superiorly and utilizing a 3rd arm to elevate it and followed it down into the bladder.It was evident that this was the mesh that was causing the puckering of the bladder urothelium and mucosa.Further sharp dissection was carried out to resect this mesh from the wall of the bladder.The cystotomy was quite small and was thus closed in a single layer of 2-0 vicryl suture in a running fashion.Cystoscopy was, again, performed showing closure of both cystotomies with no remaining mesh within the bladder.The procedure was completed.The patient was subsequently awakened and transferred to recovery room in stable condition.There were no observed complications.Blood loss was minimal and she appeared to tolerate the procedure very well.The patient was seen for a post operative visit on (b)(6) 2021.The physician reported that the patient's perioperative course has been uncomplicated and her only complaint was related to bladder spasms.

• Brand Name: LYNX 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13340790
• MDR Text Key: 284355421
• Report Number: 3005099803-2022-00121
• Device Sequence Number: 1
• Product Code: OTN
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 08/25/2022
• Supplement Dates FDA Received: 08/25/2022; 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female