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

Model Number M0068503000

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Unspecified Mental, Emotional or Behavioural Problem (4430); Sexual Dysfunction (4510); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/15/2010

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) 2010.As reported by the patient attorney, the patient has suffered the following injuries: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal, hysterectomy and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses and future out of pocket expenses and loss of income.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2010 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: imdrf patient codes e0206, e1906, e1413, e1309, e2330, e2326, e2015, e2401 capture the reportable events of urinary retention; pain; infection; inflammation; sexual dysfunction; tissue damage (vaginal tissue injury), physical injury and deformity, mental, emotional or behavioral problem.Impact code f2303, f1202.F1901, f1903, capture the reportable event of device explantation, surgery, disability and medication required.

Manufacturer Narrative

Blocks a2, b5, b7, e1 below and h6: patient codes have been updated due to additional information received on august 30, 2023.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2010, 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 surgeon is: dr.(b)(6).Assistant: dr.(b)(6).Mesh excision surgery: dr.(b)(6).Block h6: imdrf patient codes e2006, e1715, e0206, e1906, e1413, e1309, e2330, e2326, e2015, e2401 capture the reportable events of vaginal mesh erosion, granulation tissue, urinary retention; pain; infection; inflammation; sexual dysfunction; tissue damage (vaginal tissue injury), physical injury and deformity, mental, emotional or behavioral problem.Imdrf impact codes f1905, f2303, f1202 and f1901 capture the reportable event of device excision, surgery, disability and medication required.Block 11: blocks b2 and h8 have been corrected.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a total abdominal hysterectomy with abdominal sacral colpopexy + rectocele repair + lynx sub-urethral sling and cystoscopy + excision of vaginal mesh erosion (non-bsc) + cystoscopy procedure performed on (b)(6) 2010, due to large uterine prolapse and rectocele as well as persistent stress incontinence.The patient had a trans-obturator synthetic mid-urethral sling and placement of anterior perigee in 2006.During the lynx device placement, there was a large vaginal mesh erosion extending horizontally at the level of the bladder base.This was presumed to be due to its location to represent the most distal portion of the perigee device.It was then undermined and excised.The lynx device was placed, and cystourethroscopy confirmed there was no trocar injury.There was bilateral spill of indigo carmine and no evidence of injury to the bladder during the anterior colporrhaphy.Additionally, an intepro ams y-mesh was attached to the anterior and posterior vagina using interrupted figure-of-8 sutures of 2-0 pds.The patient tolerated the procedure well and was transported to recovery room in stable condition.As reported by the patient attorney, the patient has suffered the following injuries: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal, hysterectomy and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses and future out of pocket expenses and loss of income.On (b)(6), 2022, the patient had vaginal mesh excision and cystoscopy due to vaginal mesh erosion of the reported device.Findings showed atrophic vagina, a 5mm mesh erosion was noticed at the level of the vaginal cuff on the left.Also, on the right vaginal wall, few centimeters proximal to the introitus was another 5mm area of mesh erosion with granulation tissue.During the surgery, all the exposed mesh was mobilized from the vaginal wall and was dissected off.The mesh was transected with mayo scissors.The same procedure was performed at the vaginal cuff and on the right wall.There were no complications during this procedure.No bladder or urethral injuries were noticed.The patient tolerated the procedure very well.She was taken to the recovery room awake and in stable condition.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2010, 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 surgeon is: dr.(b)(6).Mesh excision surgery: dr.(b)(6).Block h6: imdrf patient codes e2006, e1715, e0206, e1906, e1413, e1309, e2330, e2326, e2015, e2401, and e0506 capture the reportable events of vaginal mesh erosion, granulation tissue, urinary retention; pain; infection; inflammation; sexual dysfunction; tissue damage (vaginal tissue injury), physical injury and deformity, mental, emotional or behavioral problem, and bleeding with intercourse and vaginal bleeding.Imdrf impact codes f1905, f2303, f1202 and f1901 capture the reportable event of device excision, surgery, disability and medication required.

Event Description

It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a total abdominal hysterectomy with abdominal sacral colpopexy + rectocele repair + lynx sub-urethral sling and cystoscopy + excision of vaginal mesh erosion (non-bsc) + cystoscopy procedure performed on (b)(6) 2010, due to large uterine prolapse and rectocele as well as persistent stress incontinence.The patient had a trans-obturator synthetic mid-urethral sling and placement of anterior perigee in 2006.During the lynx device placement, there was a large vaginal mesh erosion extending horizontally at the level of the bladder base.This was presumed to be due to its location to represent the most distal portion of the perigee device.It was then undermined and excised.The lynx device was placed, and cystourethroscopy confirmed there was no trocar injury.There was bilateral spill of indigo carmine and no evidence of injury to the bladder during the anterior colporrhaphy.Additionally, an intepro ams y-mesh was attached to the anterior and posterior vagina using interrupted figure-of-8 sutures of 2-0 pds.The patient tolerated the procedure well and was transported to recovery room in stable condition.As reported by the patient attorney, the patient has suffered the following injuries: pain, inflammation, infection, sexual dysfunction, vaginal tissue injury, urinary dysfunction, surgery for mesh removal, hysterectomy and emotional and mental anguish.Additionally, the patient has suffered the following damages: physical injury and deformity; physical disability, future medical care and treatment, medical expenses and future out of pocket expenses and loss of income.On (b)(6) 2022, the patient had vaginal mesh excision and cystoscopy due to vaginal mesh erosion of the reported device.Findings showed atrophic vagina, a 5mm mesh erosion was noticed at the level of the vaginal cuff on the left.Also, on the right vaginal wall, few centimeters proximal to the introitus was another 5mm area of mesh erosion with granulation tissue.During the surgery, all the exposed mesh was mobilized from the vaginal wall and was dissected off.The mesh was transected with mayo scissors.The same procedure was performed at the vaginal cuff and on the right wall.There were no complications during this procedure.No bladder or urethral injuries were noticed.The patient tolerated the procedure very well.She was taken to the recovery room awake and in stable condition.Additional information received on october 10, 2023: during an office visit on (b)(6) 2021, the patient presented with bleeding with intercourse but no pain.She was status post total vaginal hysterectomy with bladder repair twice for prolapse.The patient stated she was unsure if mesh was used in prolapse repair.Possible causes were reviewed, and it was likely mesh exposure - about 1 by 0.5cm mesh exposure on the right at the vaginal apex.Options were also reviewed, ombitasvir or estrogen, excision, and mesh removal.On (b)(6) 2021, the patient came for a surgery consult.She stated having vaginal bleeding daily.No pain.No hematuria.Also at the (b)(6) 2021 consult, gynecological exam found that there were two small areas of mesh exposure on the anterior vaginal wall with very thin mucosa between.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17478565
• MDR Text Key: 320565360
• Report Number: 3005099803-2023-04148
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 1ML0042002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/30/2023; 10/10/2023
• Supplement Dates FDA Received: 09/26/2023; 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 64 KG