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

Model Number M0068505001

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Hematuria (2558); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 06/24/2011

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2011, implant procedure date, as no event date was reported.Initial reporter: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2011.According to reports, the patient claims to have suffered the following injuries as a result of the implantation of the pelvic mesh: erosion, dyspareunia, chronic pain, urinary dysfunction, infections, revision surgeries, scarring, loss of enjoyment of life, physical impairment and mental anguish.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2011.According to reports, the patient claims to have suffered the following injuries as a result of the implantation of the pelvic mesh: erosion, dyspareunia, chronic pain, urinary dysfunction, infections, revision surgeries, scarring, loss of enjoyment of life, physical impairment and mental anguish.Boston scientific received an additional information on november 8, 2022, as follows: on (b)(6) 2011, the patient was implanted with obtryx system device during a transobturator tape urethropexy procedure for stress urinary incontinence.Prior to the obtryx implant portion of the procedure, a vaginal hysterectomy had been performed.On (b)(6) 2015, the patient presented at the clinic with a lower back pain, painful intercourse and pain while urinating.These conditions have been present for about two months.Post-void bladder scan was 0 ml.Exam was performed, and no cause was seen for the reported symptoms.Problem list: -stress incontinence -uterovaginal prolapse -dyspareunia -straining on urination.The plan was for the patient to schedule cystoscopy and consider urodynamics and/or back evaluation.On (b)(6) 2021, the patient was seen by a urogynecologist as a new patient for blood in her urine described as large blood clots and bright red blood.She was status post a trial of antibiotics and was pending cystoscopy.The patient had incomplete emptying but no stress or urge incontinence.She reported fullness/pressure/bulge of vaginal tissue for greater than 1 year.Exam revealed external genital and vaginal atrophy and left-sided mesh exposure (0.5mm) in the periurethral tunnel.There was no prolapse.The assessment was noted as gross hematuria, vaginal atrophy and exposure of implanted urethral mesh.During the patient's clinic visit, the items below were discussed: *they've discussed the pathophysiology of recurrent urinary tract infections and preventive strategies including optimum vulvar hygiene, cranberry tabs (twice daily), vaginal estrogen, post-coital prophylaxis, and long-term suppression.The patient will monitor her symptoms and report if she has more than three urinary tract infections in a year or two in six months.The patient will need further workup with a cystoscopy and imaging with either a computed tomography scan or a genitourinary ultrasound to evaluate for upper and lower genitourinary tract pathology.Urinalysis and urine culture were planned.*given the history of bladder surgery, a cystoscopy is required to evaluate for any foreign bodies, growths, or masses in the bladder.*vulvo-vaginal atrophy: they discussed the benefits of supplemental topical vaginal estrogen.The patient will start vaginal estrogen cream at a pea-sized amount daily for 2-3 weeks and then two to three times per week for three months.Side effects are reviewed, including vaginal discharge, burning, and irritation.In the setting of a current or prior history of breast cancer, the clinical benefits of vaginal estrogen required a candid discussion of risks and benefits with the patient, the breast surgeon, and the oncologist.*left-sided periurethral mesh exposure about 0.5 cm in size the doctor would recommend a trial of nightly premarin.If there is no improvement, the patient will need a resection.On (b)(6) 2022, the patient still had left sided groin and leg pain during her visit.She also reports dyspareunia with initial penetration.She denies urine leakage with a laugh, cough, and sneeze.She also has some difficulty initiating a stream and has had recurrent urinary tract infections for the past two years.She also denies having urinary incontinence.Exam revealed suburethral pain, pain at obturator internus muscles (l>r), and palpable cords with pain on l and r.Patient plan: *the doctor suggested preoperative urodynamic evaluation and follow up.*surgery has been offered to the patient of the previous obtryx halo sling mesh, urethral lysis and anterior colporrhaphy, as well as removal of the mesh form the obturator and adductor muscles.*the patient was extensively that even with removal of her mesh that she may continue to have pain and there is no guarantee that she will be pain free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.* the patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which include but not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022, the patient underwent the removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, and mesh removal from the deep obturator internus muscles and anterior colporrhaphy for the treatment of vaginal pain, pelvic pain, pain with coitus, muscular groin pain, leg pain, and urethral scarring.According to the surgeon, this was a very difficult surgery due to the scarring from the dissection required to remove the mesh from the left groin that was very medially implanted on the left.It was embedded in the tendon as well as the medial bone on the left.On the right, it was also very medial and against the bone.Additionally, a left lateral vulvar incision was then made over the obturator area beneath the adductor longos.Sharp dissection was carried out to locate the lateral end of the mesh and release it from its connections to the adductor muscles and the soft tissue muscles that attach to the pubic ramus.The significant amount of muscle mass, medial placement of the mesh, and placement in the tendons all contributed to making this particularly difficult.A right lateral vulvar incision was also performed over the obturator area, below the adductor longos.A sharp dissection was used to locate the lateral end of the mesh and free it from the soft tissue and muscular attachments to the pubic ramus as well as from the adductor muscles.Because of the significant muscle mass and the placement of the medial mesh, the surgeon claimed that this was quite challenging.In addition, it was observed that the foley was draining clear, yellow urine.It was necessary to access the anterior vaginal wall in order to dissect the scar tissue laterally, caudad, and cephalad.At the bladder neck, the obtryx sling was identified and carefully removed from the scar tissue.To further remove the scar tissue, a urethral lysis was carried out utilizing sharp dissection.To further dissect and visualize the mesh, the vaginal and paravaginal regions were opened.Through the scar tissue, the mesh was released and dissected into the paravaginal area.Traction and countertraction were used to locate the mesh's fixation point on the pubic ramus, which was then completely excised after being released from the bone on both the vaginal and vulvar sides.The entire of the obtryx mesh was taken out and a running locking suture of #2-0 dexon was used to close the anterior vaginal wall.On the left, interrupted sutures of #2-0 dexon were used to approximate the deep subcutaneous layer, while interrupted sutures of #3-0 plain were used to approximate the skin.Iodoform gauze packing was lightly placed to the vagina.Gravity drainage was connected to the foley.The patient tolerated the procedure well and was moved into the recovery area in excellent condition.

Manufacturer Narrative

Block h2: additional information blocks a2, b5, b7, d6b, h6 (patient, impact and device code) has been updated based on the additional information received on november 8, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2011, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).(b)(6) healthcare.(b)(6) united states.The explanting surgeon is: dr.(b)(6).Block h6: patient codes e2006, e2330, e1405, e1715, e1301, e1311, e0206, e1906, e1310, e1302, e2015, e1309 capture the reportable events of erosion, pain, dyspareunia, scar tissue, dysuria, unspecified kidney or urinary problem, unspecified mental, emotional or behavioural problem, infection, urinary tract infection, hematuria, scarring and urinary retention.Impact codes f1905 and f2303 capture the reportable events of device revision and medication required.

Manufacturer Narrative

Blocks b5, b6, b7, e1 below, and h6: patient codes have been updated based on the additional information received on september 19, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2011, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Block h6: imdrf patient codes e2006, e2330, e1405, e1715, e1301, e1311, e0206, e1906, e1310, e1302, e2015, e1309 and e1002 capture the reportable events of erosion, pain, dyspareunia, scar tissue, dysuria, unspecified kidney or urinary problem, unspecified mental, emotional or behavioural problem, infection, urinary tract infection, hematuria, scarring, urinary retention, and abdominal pain.Imdrf impact codes f1905 and f2303 capture the reportable events of device revision and medication required.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2011.According to reports, the patient claims to have suffered the following injuries as a result of the implantation of the pelvic mesh: erosion, dyspareunia, chronic pain, urinary dysfunction, infections, revision surgeries, scarring, loss of enjoyment of life, physical impairment and mental anguish.Boston scientific received an additional information on november 8, 2022, as follows: on (b)(6) 2011, the patient was implanted with obtryx system device during a transobturator tape urethropexy procedure for stress urinary incontinence.Prior to the obtryx implant portion of the procedure, a vaginal hysterectomy had been performed.On (b)(6) 2015, the patient presented at the clinic with a lower back pain, painful intercourse and pain while urinating.These conditions have been present for about two months.Post-void bladder scan was 0 ml.Exam was performed, and no cause was seen for the reported symptoms.Problem list: stress incontinence; uterovaginal prolapse; dyspareunia; straining on urination.The plan was for the patient to schedule cystoscopy and consider urodynamics and/or back evaluation.On (b)(6) 2021, the patient was seen by a urogynecologist as a new patient for blood in her urine described as large blood clots and bright red blood.She was status post a trial of antibiotics and was pending cystoscopy.The patient had incomplete emptying but no stress or urge incontinence.She reported fullness/pressure/bulge of vaginal tissue for greater than 1 year.Exam revealed external genital and vaginal atrophy and left-sided mesh exposure (0.5mm) in the periurethral tunnel.There was no prolapse.The assessment was noted as gross hematuria, vaginal atrophy and exposure of implanted urethral mesh.During the patient's clinic visit, the items below were discussed: they've discussed the pathophysiology of recurrent urinary tract infections and preventive strategies including optimum vulvar hygiene, cranberry tabs (twice daily), vaginal estrogen, post-coital prophylaxis, and long-term suppression.The patient will monitor her symptoms and report if she has more than three urinary tract infections in a year or two in six months.The patient will need further workup with a cystoscopy and imaging with either a computed tomography scan or a genitourinary ultrasound to evaluate for upper and lower genitourinary tract pathology.Urinalysis and urine culture were planned.Given the history of bladder surgery, a cystoscopy is required to evaluate for any foreign bodies, growths, or masses in the bladder.Vulvo-vaginal atrophy: they discussed the benefits of supplemental topical vaginal estrogen.The patient will start vaginal estrogen cream at a pea-sized amount daily for 2-3 weeks and then two to three times per week for three months.Side effects are reviewed, including vaginal discharge, burning, and irritation.In the setting of a current or prior history of breast cancer, the clinical benefits of vaginal estrogen required a candid discussion of risks and benefits with the patient, the breast surgeon, and the oncologist.Left-sided periurethral mesh exposure about 0.5 cm in size the doctor would recommend a trial of nightly premarin.If there is no improvement, the patient will need a resection.On (b)(6) 2022, the patient still had left sided groin and leg pain during her visit.She also reports dyspareunia with initial penetration.She denies urine leakage with a laugh, cough, and sneeze.She also has some difficulty initiating a stream and has had recurrent urinary tract infections for the past two years.She also denies having urinary incontinence.Exam revealed suburethral pain, pain at obturator internus muscles (l>r), and palpable cords with pain on l and r.Patient plan: the doctor suggested preoperative urodynamic evaluation and follow up.Surgery has been offered to the patient of the previous obtryx halo sling mesh, urethral lysis and anterior colporrhaphy, as well as removal of the mesh form the obturator and adductor muscles.The patient was extensively that even with removal of her mesh that she may continue to have pain and there is no guarantee that she will be pain free or even improved from the pain.She was also counseled that she would not undergo reconstruction with this surgery as this would be only to remove the mesh.The patient has been counseled on the risks and benefits of surgery, alternate approaches and procedures as well as complications which include but not limited to bleeding, infection as well as failure to achieve the desired physiologic result.The patient stated that she understood, had no questions, was given an opportunity to ask questions and wished to proceed with surgery.On (b)(6) 2022, the patient underwent the removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, and mesh removal from the deep obturator internus muscles and anterior colporrhaphy for the treatment of vaginal pain, pelvic pain, pain with coitus, muscular groin pain, leg pain, and urethral scarring.According to the surgeon, this was a very difficult surgery due to the scarring from the dissection required to remove the mesh from the left groin that was very medially implanted on the left.It was embedded in the tendon as well as the medial bone on the left.On the right, it was also very medial and against the bone.Additionally, a left lateral vulvar incision was then made over the obturator area beneath the adductor longos.Sharp dissection was carried out to locate the lateral end of the mesh and release it from its connections to the adductor muscles and the soft tissue muscles that attach to the pubic ramus.The significant amount of muscle mass, medial placement of the mesh, and placement in the tendons all contributed to making this particularly difficult.A right lateral vulvar incision was also performed over the obturator area, below the adductor longos.A sharp dissection was used to locate the lateral end of the mesh and free it from the soft tissue and muscular attachments to the pubic ramus as well as from the adductor muscles.Because of the significant muscle mass and the placement of the medial mesh, the surgeon claimed that this was quite challenging.In addition, it was observed that the foley was draining clear, yellow urine.It was necessary to access the anterior vaginal wall in order to dissect the scar tissue laterally, caudad, and cephalad.At the bladder neck, the obtryx sling was identified and carefully removed from the scar tissue.To further remove the scar tissue, a urethral lysis was carried out utilizing sharp dissection.To further dissect and visualize the mesh, the vaginal and paravaginal regions were opened.Through the scar tissue, the mesh was released and dissected into the paravaginal area.Traction and countertraction were used to locate the mesh's fixation point on the pubic ramus, which was then completely excised after being released from the bone on both the vaginal and vulvar sides.The entire of the obtryx mesh was taken out and a running locking suture of #2-0 dexon was used to close the anterior vaginal wall.On the left, interrupted sutures of #2-0 dexon were used to approximate the deep subcutaneous layer, while interrupted sutures of #3-0 plain were used to approximate the skin.Iodoform gauze packing was lightly placed to the vagina.Gravity drainage was connected to the foley.The patient tolerated the procedure well and was moved into the recovery area in excellent condition.It was also reported that the patient was positive for environmental allergies, seasonal allergies, and abdominal pain.

• Brand Name: OBTRYX 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15597905
• MDR Text Key: 301725530
• Report Number: 3005099803-2022-05885
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML1022804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female