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

Model Number M0068503000

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Inflammation (1932); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Hernia (2240); Anxiety (2328); Depression (2361); Dysuria (2684); Fibrosis (3167); Dyspareunia (4505); Insufficient Information (4580)

Event Date 05/31/2017

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) 2017.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(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) 2017.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on april 17, 2023: on (b)(6) 2020, the patient had to undergo mesh excision surgery, lysis of adhesions.Removal of adnexa cyst and paratubal cyst, and placement of ureter stent and biological graft as she was complaining of abdominal pain and adhesions due to the implanted mesh.Findings: dense adhesions of the bowel to the anterior abdominal wall.Adhesions of the sacrocolpopexy mesh to the vaginal cuff, bladder as well as to the bowel.The mesh was loose and almost curled up.The mesh attached to the vagina appeared inflamed and fibrotic.Indications: the patient initially underwent a diagnostic laparoscopy which revealed evidence of mesh exposure in the abdomen and dense adhesions to the abdominal wall.On examination, she was noted to have significant vaginal and abdominal tenderness.Per the patient, these symptoms all started after placement of her sacrocolpopexy mesh several years prior.Procedure: mesh appeared to be extremely loose and did not appear to be offering any support.In addition, it was adhered to the small and large bowel and was attached to the vaginal cuff as well.Lysis of adhesions was performed using sharp dissection freeing the mesh from the small and large bowel and dissecting the vesicovaginal space and freeing the mesh and mobilizing the bladder.The mesh along with some of the vaginal cuff was removed so there was approximately a 3cm defect in the vaginal cuff.Continued to dissect the mesh up toward the sacrum and then incised it from the sacral promontory and the specimen was then handed off to the operative field.The right adnexa were identified.There was a paratubal cyst that was noted and was then grasped and incised.Then, a matristem biologic graft was placed due to the presence of all the inflammation and in order to avoid any cuff complications.The patient was then extubated and taken to the recovery room in stable condition.

Manufacturer Narrative

Blocks a2: dob, b2: outcomes attrib to adv event, b5, e1 below and h6 patient codes, impact codes and device codes have been updated based on the additional information received on april 17, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).Mesh excision surgeon is: dr.(b)(6).Assistant: dr.(b)(6).(b)(6).(b)(6) hospital.(b)(6).Block h6: imdrf patient codes e2006, e2101, e2330, e1002, e2313 and e2326 capture the reportable events of mesh exposure in the abdomen, adhesions, vaginal tenderness, abdominal pain, fibrotic, inflammation, and adnexal cyst and paratubal cyst.Imdrf impact codes f1905, f1901 and f2301 capture the reportable events of mesh excision, lysis of adhesions, excision of right paratubal cyst and placement of biological graft and ureteral stent placement.

Manufacturer Narrative

Blocks a4, b2, b5, b7, e1 below and h6: patient codes and impact codes have been updated based on the additional information received on june 27, 2023.Block b3 date of event: date of event was approximated to may 31, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Assistant: dr.(b)(6).(b)(6) medical center.Mesh excision surgeon is: dr.(b)(6).Assistant: dr.(b)(6).(b)(6) hospital.Block h6: imdrf patient codes e2006, e2101, e2330, e1002, e2313, e2326, e1405, e1301, e1715, e2319 and e1401 capture the reportable events of mesh exposure in the abdomen, adhesions, vaginal tenderness, abdominal pain, fibrotic, inflammation, and adnexal cyst, paratubal cyst, not sexually active, dysuria, scar at the vaginal apex or cuff, hiatal hernia, and vaginal discharge.Imdrf impact codes f1905, f1901, f2301 and f1202 capture the reportable events of mesh excision, lysis of adhesions, excision of right paratubal cyst and placement of biological graft and ureteral stent placement, and disability.

Event Description

Note: this manufacturer report pertains to one of the two devices implanted during the same procedure.Refer to manufacturer report number 3005099803-2022-04995 for upsylon device.It was reported to boston scientific corporation that a lynx system device was implanted into the patient during a pubovaginal sling using mesh + abdominal colposacropexy using mesh + lysis of abdominal adhesions + dissection of the right ureter + cystoscopy procedure performed on (b)(6) 2017 to treat severe vaginal vault prolapse with stress urinary incontinence.The patient was successfully extubated in the operating room and was transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on april 17, 2023: on (b)(6) 2020, the patient had to undergo mesh excision surgery, lysis of adhesions.Removal of adnexa cyst and paratubal cyst, and placement of ureter stent and biological graft as she was complaining of abdominal pain and adhesions due to the implanted mesh.Findings: dense adhesions of the bowel to the anterior abdominal wall.Adhesions of the sacrocolpopexy mesh to the vaginal cuff, bladder as well as to the bowel.The mesh was loose and almost curled up.The mesh attached to the vagina appeared inflamed and fibrotic.Indications: the patient initially underwent a diagnostic laparoscopy which revealed evidence of mesh exposure in the abdomen and dense adhesions to the abdominal wall.On examination, she was noted to have significant vaginal and abdominal tenderness.Per the patient, these symptoms all started after placement of her sacrocolpopexy mesh several years prior.Procedure: mesh appeared to be extremely loose and did not appear to be offering any support.In addition, it was adhered to the small and large bowel and was attached to the vaginal cuff as well.Lysis of adhesions was performed using sharp dissection freeing the mesh from the small and large bowel and dissecting the vesicovaginal space and freeing the mesh and mobilizing the bladder.The mesh along with some of the vaginal cuff was removed so there was approximately a 3cm defect in the vaginal cuff.Continued to dissect the mesh up toward the sacrum and then incised it from the sacral promontory and the specimen was then handed off to the operative field.The right adnexa were identified.There was a paratubal cyst that was noted and was then grasped and incised.Then, a matristem biologic graft was placed due to the presence of all the inflammation and in order to avoid any cuff complications.The patient was then extubated and taken to the recovery room in stable condition.Additional information received on june 27, 2023: in an office visit on (b)(6) 2020, patient stated she was not sexually active and had been experiencing vaginal discharge and dysuria.A prior vertical scar was also noted.At the vaginal apex or cuff, the physician felt a firm nodule likely a mesh or permanent suture or possible scar.The patient then underwent mri pelvis and the diagnose resulted in erosion of bladder suspension mesh.Diagnosis also reported left ovarian cyst and hiatal hernia.On (b)(6) 2020, it was reported that patient's urine flow slowed down after the mesh placement.Then she had pelvic pains.Pain was so severe that she had to go into the emergency room and was taking tramadol and norco for the pain.Ct scan in (b)(6) showed multiloculated cyst in the left ovary.On (b)(6) 2020, she underwent laparoscopic ovarian cystectomy and during laparoscopy, the gynecologist noted erosion of bladder mesh in pelvis could probably be causing the pain.Pelvic pain was causing her inability to work.The patient could not do lifting, bending, pushing, pulling and carrying heavy loads which were required at her work.She was then given disability for 3 months.The patient had pelvic ultrasound on (b)(6) 2020 to reassess left adnexal cyst.It was also reported that the patient had suffered anxiety and depression.

• 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: 15334691
• MDR Text Key: 299046431
• Report Number: 3005099803-2022-04994
• 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: 07/24/2023

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: 04/28/2018
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0020580665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 04/17/2023; 06/27/2023
• Supplement Dates FDA Received: 05/10/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 61 KG