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

BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068504110

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

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Disability (2371); Impaired Healing (2378); Numbness (2415); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Balance Problems (4401); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 09/09/2019

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 (implant date) as no event date was reported.(b)(6).The device was implanted at the (b)(6) hospital, (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2019 (initial clinic visit postoperatively) as no event date was reported.Block e1: patient's other lawyers: (b)(6).The device was implanted at the (b)(6) hospital, (b)(6).Implanting surgeon: dr.(b)(6) regional hospital).Attempted mesh excision/extraction: dr.(b)(6) ((b)(6) hospital).Block h6: patient codes e1405, e1715, e1301, e1309, e1023, e2326, e0506, e2330, e1002, e1310 capture the reportable events of physical impairment, nerve injuries, pain, abdominal pain, urinary retention, painful intercourse, scarring, dysuria, inflammation, vaginal bleeding and urinary tract infection.Impact codes f19 and f2303 capture the reportable event of attempted mesh removal/extraction and medications required.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block b3 date of event: date of event was approximated to september 9, 2019 (initial clinic visit postoperatively) as no event date was reported.Block e1: patient's other lawyers: (b)(6).The device was implanted at the (b)(6) hospital, (b)(6).Implanting surgeon: dr.((b)(6) hospital).Attempted mesh excision/extraction: dr.(b)(6) ((b)(6) hospital).Bilateral groin exploration surgery: dr.(b)(6).Block h6: patient codes e1405, e1715, e1301, e1309, e1023, e2326, e0506, e2330, e1002, e1310, e2340 capture the reportable events of physical impairment, nerve injuries, pain, abdominal pain, urinary retention, painful intercourse, scarring, dysuria, inflammation/infection, vaginal bleeding ,urinary tract infection and wound dehiscence.Impact codes f19, f2303 and f08 capture the reportable event of attempted mesh removal/extraction and medications required, as well as additional surgery (groin exploration) and prolonged hospital stay.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure 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 an obtryx ii system - curved device was implanted during a procedure performed on (b)(6), 2019.As per reported by the patient's attorney, as a result of the device implantation, the patient has suffered abdominal and pelvic pain, recurrence of prolapse, urinary problems, scarring, nerve injuries including injury to obturator and pudendal nerves, physical impairment, emotional distress, and suffering.Subsequently, the patient is currently receiving treatment.It is unknown what urinary problems the patient has experienced and boston scientific has been unable to obtain additional information regarding the event to date.Boston scientific has considered the worst case scenario such as the patient has experienced urinary retention.***additional information received on january 14, 2022*** on (b)(6), 2019 , patient underwent total vaginal hysterectomy, posterior repair, sacral ligament suspension bilaterally, cystoscopy, tension free vaginal tape transobturator.Diagnosis: uterovaginal prolapse and urinary stress incontinence.Estimated blood loss of 400cc.No complications.On (b)(6), 2019, patient presented with complaints of vaginal pain, obturator neuralgia and pudendal neuralgia.Postoperatively there were issues with retention.She also had some vaginal bleeding, had to stay an extra day in the hospital and nearly failed her trial of voiding.Patient immediately noted back pain stretching across her mid sacral region.She never noted this type of pain prior to surgery.Over the next several weeks she noted onset of vaginal pain as well as pain radiating down the inner right thigh.Also, a sense of pelvic pressure was noted.She noted early satiety and noted that she has lost all clitoral sensation.Stimulation of the clitoris yields no arousal effect.The patient tried to have intercourse which caused severe pain and bleeding.She notes recurrent urinary incontinence with frequency and urgency.She also occasionally gets bowel urgency as well.She has noted some minimal seepage of stool.She also notes pain with sitting especially in the right ischial tuberosity region.Patient has difficulty with ambulation making the pain in the thigh worse.At the time of this appointment, relevant medical and surgical history included degenerative joint disease, osteoarthritis, uti, appendectomy and cholecystectomy, cervical fusion, knee replacement, right ankle fusion, and shoulder replacement.Physical exam revealed tenderness of the mid sacral region, positive skin rolling sensitivity especially at the medial right thigh, minimal diffuse allodynia, and positive point tenderness along the inferior pubic rami (r>l).The mesh was readily palpable and quite tender to palpation, the levator plate was also tender without significant hypertonus.Both sacrospinous ligament complexes were mildly to moderately tender.The impression was right-sided obturator neuralgia with vaginal pain and irritative bladder symptoms secondary to the tvt-o mesh.The patient also has some elements of pudendal neuralgia possibly from a combination of factors both mesh and sacrospinous fixation.On (b)(6), 2019, patient underwent transobturator tape mesh excision procedure, cystocele repair, and right sided groin exploration.During the procedure, a small to moderate cystocele was noted.The mesh for the midurethral sling was identified and divided in the midline.The left side was followed up to the level of the obturator membrane and divided there and the section removed.After attempts to locate the right side of the mesh in the groin compartment, this was discontinued, and the right side removed from the level of the obturator membrane as was done on the left side.A cystocele repair was then performed as a large paravaginal defect had been made during dissection.Postoperatively, pain control was adequate with oral hydromorphone.Condition was stable.Pathology report of specimen indicates fibroadipose tissue with foreign body-type giant cells and some mild chronic inflammation.On (b)(6), 2020, patient again underwent bilateral groin exploration with attempted mesh extraction.Following the mesh excision in (b)(6) 2019, the patient's right-sided obturator neuralgia symptoms continued and started to develop symptoms on the left side as well as groin pain radiating down both medial thighs, vaginal pain, and pain with sitting.Urinary complaints were minimal and there were no bowel complaints.Surgeon was unable to locate either piece of groin mesh.Diagnoses: postoperative obturator neuralgia, pudendal neuralgia and vaginal pain.Postoperatively, the patient had poor pain control for which pain medication was adjusted.A drg stimulator was also discussed as a potential treatment method moving forward.On (b)(6), 2020, the patient was evaluated at a pain management clinic for pain related to many reasons including cervical spine surgery x 3, mesh removal and infection that the patient felt was mismanaged, nerve pain in the pelvis that radiates to the back of her left leg and inside her right leg, rotator cuff issues that require surgery, "whole body arthritis" since childhood, lower back pain, and sciatica.She reported the following in association with the pain: bowel incontinence, numbness and tingling, balance problems, muscle weakness in her entire body, and sleep disturbances.Treatments had included chiropractic care, physical therapy, trigger point injections, tens unit, spinal injections, and narcotic pain medication.The patient's current medications included gabapentin and percocet.Treatment included oxycodone for low back pain, seroquel for major depressive disorder, plan to have ls spinal injections after shoulder surgery, and weight loss.On (b)(6), 2021, the patient presented to the emergency room for symptoms of suprapubic pressure and urinary frequency that started almost 2 weeks prior and had been treated with bactrim for 10 days without improvement.She also reported a history of frequent utis.Urinalysis showed no abnormalities.The patient was prescribed phenazopyridine.***additional information received on january 26, 2022*** on (b)(6), 2019, patient presented for evaluation of continued dysuria.Patient stated she had a surgery scheduled in about two months to remove the implanted surgical mesh.Patient stated she has had increased pain in that area and has not had any real relief over the past couple of days.She adds she has noticed that her pain has gotten worse as well.Urinalysis showed 2+ blood.She was given ketorolac tromethamine 60mg/2ml and solu-medrol 125mg and referred to the urology service.On (b)(6), 2019, patient went for follow-up for continued abdominal pain.She had an extensive medical history related to bladder sling with complications.She had been treated several times for a uti.She was most recently treated with ciprofloxacin.The assessment was a urinary tract infection, and the patient was administered toradol 60mg and prescribed bactrim.On (b)(6), 2019, patient presented with continued bladder pain/pelvic pain.She noted that she was previously sent for a urology appointment but had not followed up yet.She stated she was in a lot of pain but did not want to go to the hospital for admission.The assessment was increased urinary frequency/polyuria, and cystocele/bladder prolapse.She was administered ketorolac tromethamine 60mg/2ml.She was referred to infectious disease for placement of a picc line to be given cefepime iv twice daily for 10 days.She was to continue follow up with infectious disease and urology as planned.***additional information received on march 23, 2022*** on (b)(6), 2019, patient was evaluated for urinary incontinence.She reported being most bothered by severe leaking that has returned.She also reported urinary urgency and frequency, pain during urination, visible blood in the urine, difficulty starting her urine stream, and a sensation of incomplete bladder emptying.She also reported leakage of both solid and liquid stool and gas.She has been using vaginal estrogen for the vaginal atrophy but seemed to make her pain worse.During the visit, catheterization was performed to evaluate for incomplete emptying with finding of 10ml postvoid residual urine.The impression was stress urinary incontinence for which a pessary was fitted; obturator neuralgia s/p tot with subsequent partial excision for which the patient was referred for pelvic floor physical therapy (pfpt); and vaginal atrophy for which vaginal estrogen was prescribed.During a phone call on (b)(6), 2019, patient reported new stabbing-like pain on her right side that sometimes goes down her leg, sometimes up her flank ( she later said left side).This was a new pain on top of her chronic pain from the previously placed sling.Patient is taking tylenol; md recommends increasing her gabapentin dosage.Patient also reports some dysuria/bladder pain but that the pessary has improved her incontinence symptoms.Patient went for a follow-up visit on (b)(6), 2019 due to the same symptoms of neuralgia, severe atrophy and stress urinary incontinence (sui).Patient made succeeding follow-up visits on (b)(6), 2020 for same symptoms (pain, sui).On (b)(6) 2020, patient underwent bilateral groin exploration surgery (no mesh was identified).Five days later, she fell while opening her horse trailer which resulted in postoperative wound dehiscence of her right groin and bleeding.She was seen in the emergency department the following day where ct scan showed subcutaneous soft tissue gas and edema within the perineum and medial thigh region (right greater than left).Home health was assigned to visit daily for wound care.On (b)(6), 2020, the patient was evaluated and reported continued drainage from her wound but did not have any packing in.Exam revealed the right groin wound had granulation tissue and exudate expected for ongoing healing and was without any evidence of active infection.The physician suspected a postop seroma may have been present that caused the dehiscence when the patient fell.The wound was cleaned and packed, the patient was started on augmentin, home health was to continue daily wound care, and the patient was referred to a physician with experience in groin area tumors to determine any further treatment.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted during a procedure performed on (b)(6) 2019.As per reported by the patient's attorney, as a result of the device implantation, the patient has suffered abdominal and pelvic pain, recurrence of prolapse, urinary problems, scarring, nerve injuries including injury to obturator and pudendal nerves, physical impairment, emotional distress, and suffering.Subsequently, the patient is currently receiving treatment.It is unknown what urinary problems the patient has experienced and boston scientific has been unable to obtain additional information regarding the event to date.Boston scientific has considered the worst case scenario such as the patient has experienced urinary retention.Additional information received on january 14, 2022: on (b)(6) 2019 , patient underwent total vaginal hysterectomy, posterior repair, sacral ligament suspension bilaterally, cystoscopy, tension free vaginal tape transobturator.Diagnosis: uterovaginal prolapse and urinary stress incontinence.Estimated blood loss of 400cc.No complications.On (b)(6) 2019, patient presented with complaints of vaginal pain, obturator neuralgia and pudendal neuralgia.Postoperatively there were issues with retention.She also had some vaginal bleeding, had to stay an extra day in the hospital and nearly failed her trial of voiding.Patient immediately noted back pain stretching across her mid sacral region.She never noted this type of pain prior to surgery.Over the next several weeks she noted onset of vaginal pain as well as pain radiating down the inner right thigh.Also, a sense of pelvic pressure was noted.She noted early satiety and noted that she has lost all clitoral sensation.Stimulation of the clitoris yields no arousal effect.The patient tried to have intercourse which caused severe pain and bleeding.She notes recurrent urinary incontinence with frequency and urgency.She also occasionally gets bowel urgency as well.She has noted some minimal seepage of stool.She also notes pain with sitting especially in the right ischial tuberosity region.Patient has difficulty with ambulation making the pain in the thigh worse.At the time of this appointment, relevant medical and surgical history included degenerative joint disease, osteoarthritis, uti, appendectomy and cholecystectomy, cervical fusion, knee replacement, right ankle fusion, and shoulder replacement.Physical exam revealed tenderness of the mid sacral region, positive skin rolling sensitivity especially at the medial right thigh, minimal diffuse allodynia, and positive point tenderness along the inferior pubic rami (r>l).The mesh was readily palpable and quite tender to palpation, the levator plate was also tender without significant hypertonus.Both sacrospinous ligament complexes were mildly to moderately tender.The impression was right-sided obturator neuralgia with vaginal pain and irritative bladder symptoms secondary to the tvt-o mesh.The patient also has some elements of pudendal neuralgia possibly from a combination of factors both mesh and sacrospinous fixation.On (b)(6) 2019, patient underwent transobturator tape mesh excision procedure, cystocele repair, and right sided groin exploration.During the procedure, a small to moderate cystocele was noted.The mesh for the midurethral sling was identified and divided in the midline.The left side was followed up to the level of the obturator membrane and divided there and the section removed.After attempts to locate the right side of the mesh in the groin compartment, this was discontinued, and the right side removed from the level of the obturator membrane as was done on the left side.A cystocele repair was then performed as a large paravaginal defect had been made during dissection.Postoperatively, pain control was adequate with oral hydromorphone.Condition was stable.Pathology report of specimen indicates fibroadipose tissue with foreign body-type giant cells and some mild chronic inflammation.On (b)(6) 2020, patient again underwent bilateral groin exploration with attempted mesh extraction.Following the mesh excision in (b)(6) 2019, the patient's right-sided obturator neuralgia symptoms continued and started to develop symptoms on the left side as well as groin pain radiating down both medial thighs, vaginal pain, and pain with sitting.Urinary complaints were minimal and there were no bowel complaints.Surgeon was unable to locate either piece of groin mesh.Diagnoses: postoperative obturator neuralgia, pudendal neuralgia and vaginal pain.Postoperatively, the patient had poor pain control for which pain medication was adjusted.A drg stimulator was also discussed as a potential treatment method moving forward.On (b)(6) 2020, the patient was evaluated at a pain management clinic for pain related to many reasons including cervical spine surgery x 3, mesh removal and infection that the patient felt was mismanaged, nerve pain in the pelvis that radiates to the back of her left leg and inside her right leg, rotator cuff issues that require surgery, "whole body arthritis" since childhood, lower back pain, and sciatica.She reported the following in association with the pain: bowel incontinence, numbness and tingling, balance problems, muscle weakness in her entire body, and sleep disturbances.Treatments had included chiropractic care, physical therapy, trigger point injections, tens unit, spinal injections, and narcotic pain medication.The patient's current medications included gabapentin and percocet.Treatment included oxycodone for low back pain, seroquel for major depressive disorder, plan to have ls spinal injections after shoulder surgery, and weight loss.On (b)(6) 2021, the patient presented to the emergency room for symptoms of suprapubic pressure and urinary frequency that started almost 2 weeks prior and had been treated with bactrim for 10 days without improvement.She also reported a history of frequent utis.Urinalysis showed no abnormalities.The patient was prescribed phenazopyridine.Additional information received on january 26, 2022.On (b)(6) 2019, patient presented for evaluation of continued dysuria.Patient stated she had a surgery scheduled in about two months to remove the implanted surgical mesh.Patient stated she has had increased pain in that area and has not had any real relief over the past couple of days.She adds she has noticed that her pain has gotten worse as well.Urinalysis showed 2+ blood.She was given ketorolac tromethamine 60mg/2ml and solu-medrol 125mg and referred to the urology service.On (b)(6) 2019, patient went for follow-up for continued abdominal pain.She had an extensive medical history related to bladder sling with complications.She had been treated several times for a uti.She was most recently treated with ciprofloxacin.The assessment was a urinary tract infection, and the patient was administered toradol 60mg and prescribed bactrim.On (b)(6) 2019, patient presented with continued bladder pain/pelvic pain.She noted that she was previously sent for a urology appointment but had not followed up yet.She stated she was in a lot of pain but did not want to go to the hospital for admission.The assessment was increased urinary frequency/polyuria, and cystocele/bladder prolapse.She was administered ketorolac tromethamine 60mg/2ml.She was referred to infectious disease for placement of a picc line to be given cefepime iv twice daily for 10 days.She was to continue follow up with infectious disease and urology as planned.Additional information received on march 23, 2022.On (b)(6) 2019, patient was evaluated for urinary incontinence.She reported being most bothered by severe leaking that has returned.She also reported urinary urgency and frequency, pain during urination, visible blood in the urine, difficulty starting her urine stream, and a sensation of incomplete bladder emptying.She also reported leakage of both solid and liquid stool and gas.She has been using vaginal estrogen for the vaginal atrophy but seemed to make her pain worse.During the visit, catheterization was performed to evaluate for incomplete emptying with finding of 10ml postvoid residual urine.The impression was stress urinary incontinence for which a pessary was fitted; obturator neuralgia s/p tot with subsequent partial excision for which the patient was referred for pelvic floor physical therapy (pfpt); and vaginal atrophy for which vaginal estrogen was prescribed.During a phone call on (b)(6) 2019, patient reported new stabbing-like pain on her right side that sometimes goes down her leg, sometimes up her flank ( she later said left side).This was a new pain on top of her chronic pain from the previously placed sling.Patient is taking tylenol; md recommends increasing her gabapentin dosage.Patient also reports some dysuria/bladder pain but that the pessary has improved her incontinence symptoms.Patient went for a follow-up visit on (b)(6) 2019 due to the same symptoms of neuralgia, severe atrophy and stress urinary incontinence (sui).Patient made succeeding follow-up visits on (b)(6) 2020 for same symptoms (pain, sui).On (b)(6) 2020, patient underwent bilateral groin exploration surgery (no mesh was identified).Five days later, she fell while opening her horse trailer which resulted in postoperative wound dehiscence of her right groin and bleeding.She was seen in the emergency department the following day where ct scan showed subcutaneous soft tissue gas and edema within the perineum and medial thigh region (right greater than left).Home health was assigned to visit daily for wound care.On (b)(6) 2020, the patient was evaluated and reported continued drainage from her wound but did not have any packing in.Exam revealed the right groin wound had granulation tissue and exudate expected for ongoing healing and was without any evidence of active infection.The physician suspected a postop seroma may have been present that caused the dehiscence when the patient fell.The wound was cleaned and packed, the patient was started on augmentin, home health was to continue daily wound care, and the patient was referred to a physician with experience in groin area tumors to determine any further treatment.Additional information received on june 13, 2022.On (b)(6) 2019, the patient presented with complaints of abdominal pain and uti symptoms (dysuria with burning sensation) with onset four days ago.She reported that over the past few days after her mesh removal surgery a week ago, she developed dysuria associated with burning with urination.Abdominal pain, dysuria and urinary frequency were noted on her physical exam.During evaluation following treatment, the patient reported that she feels better.She was prescribed keflex and will pursue further outpatient evaluation.On (b)(6) 2019, she complained of severe lue (left upper extremity) pain after insertion of picc line that was performed on the same day.Reportedly, the pain radiates from her fingers up the extremity into the shoulder, the neck and the back of her head.She also reported tingling and numbness in her left hand.She noted being shaky and having a headache.She stated that she was fine until a picc line was placed for ic antibiotic therapy.She mentioned that she had a revision surgery performed but has retained infected parts of mesh that has resulted in a persistent inflammatory process/infection in her abdomen requiring the use of iv antibiotics for which the picc line was inserted.Imaging studies of the picc line were performed in the emergency department which revealed that the picc was in good placement.The ultrasound does not show any evidence of abnormality or dvt.However, since the patient was having intractable pain, she requested for picc line removal.Diagnostic studies: ultrasound of the left upper extremity interpreted as no evidence of dvt.Diagnoses: diagnoses, assessment and plan noted at that time: 1.Acute uti.Oral antibiotics failed.Cirtobacter freundii in urine noted.Patient was advised to start 1g cefepime iv every 12 hours for ten days.Okay to place midline.2.Lue pain after picc line insertion.Ultrasound revealed negative for dvt (deep vein thrombosis); however, dvt prophylaxis was given.Due to the patient's severity of pain and request for picc line removal, picc line will be removed.Patient was to be reevaluated in the morning for reinsertion of picc, possibly in the other upper extremity.To consultation with infection disease if needed for iv antibiotic therapy.Given the pain being in the patient's left arm and the radiating pain despite the absence of chest pain, it was decided to obtain serial cardiac enzymes and serial ekgs to exclude a cardiac component.The patient can resume cefepime iv once midline has been placed.On revaluation: tramadol was ordered as the patient requested pain medications at bedside.The patient felt better and pain had improved.She was admitted for observation.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to september 9, 2019 (initial clinic visit postoperatively) as no event date was reported.Block e1: patient's other lawyers: (b)(6).The device was implanted at (b)(6) hospital, (b)(6).Implanting surgeon: dr.(b)(6) assisted by dr.(b)(6) attempted mesh excision/extraction: dr.(b)(6).Bilateral groin exploration surgery: dr.(b)(6).Block h6: patient codes e1405, e1715, e1301, e1309, e1023, e2326, e0506, e2330, e1002, e1310, e2340 capture the reportable events of physical impairment, nerve injuries, pain, abdominal pain, urinary retention, painful intercourse, scarring, dysuria, inflammation/infection, vaginal bleeding ,urinary tract infection and wound dehiscence.Impact codes f19, f2303, f08 and f1905 capture the reportable events of attempted mesh removal/extraction and medications required, as well as additional surgery (groin exploration), prolonged hospital stay and mesh revision.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure 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 an obtryx ii system - curved device was implanted during a procedure performed on (b)(6) 2019.As per reported by the patient's attorney, as a result of the device implantation, the patient has suffered abdominal and pelvic pain, recurrence of prolapse, urinary problems, scarring, nerve injuries including injury to obturator and pudendal nerves, physical impairment, emotional distress, and suffering.Subsequently, the patient is currently receiving treatment.It is unknown what urinary problems the patient has experienced and boston scientific has been unable to obtain additional information regarding the event to date.Boston scientific has considered the worst case scenario such as the patient has experienced urinary retention.Additional information received on january 14, 2022.On (b)(6) 2019, patient underwent total vaginal hysterectomy, posterior repair, sacral ligament suspension bilaterally, cystoscopy, tension free vaginal tape transobturator.Diagnosis: uterovaginal prolapse and urinary stress incontinence.Estimated blood loss of 400cc.No complications.On (b)(6) 2019, patient presented with complaints of vaginal pain, obturator neuralgia and pudendal neuralgia.Postoperatively there were issues with retention.She also had some vaginal bleeding, had to stay an extra day in the hospital and nearly failed her trial of voiding.Patient immediately noted back pain stretching across her mid sacral region.She never noted this type of pain prior to surgery.Over the next several weeks she noted onset of vaginal pain as well as pain radiating down the inner right thigh.Also, a sense of pelvic pressure was noted.She noted early satiety and noted that she has lost all clitoral sensation.Stimulation of the clitoris yields no arousal effect.The patient tried to have intercourse which caused severe pain and bleeding.She notes recurrent urinary incontinence with frequency and urgency.She also occasionally gets bowel urgency as well.She has noted some minimal seepage of stool.She also notes pain with sitting especially in the right ischial tuberosity region.Patient has difficulty with ambulation making the pain in the thigh worse.At the time of this appointment, relevant medical and surgical history included degenerative joint disease, osteoarthritis, uti, appendectomy and cholecystectomy, cervical fusion, knee replacement, right ankle fusion, and shoulder replacement.Physical exam revealed tenderness of the mid sacral region, positive skin rolling sensitivity especially at the medial right thigh, minimal diffuse allodynia, and positive point tenderness along the inferior pubic rami (r>l).The mesh was readily palpable and quite tender to palpation, the levator plate was also tender without significant hypertonus.Both sacrospinous ligament complexes were mildly to moderately tender.The impression was right-sided obturator neuralgia with vaginal pain and irritative bladder symptoms secondary to the tvt-o mesh.The patient also has some elements of pudendal neuralgia possibly from a combination of factors both mesh and sacrospinous fixation.On (b)(6) 2019, patient underwent transobturator tape mesh excision procedure, cystocele repair, and right sided groin exploration.During the procedure, a small to moderate cystocele was noted.The mesh for the midurethral sling was identified and divided in the midline.The left side was followed up to the level of the obturator membrane and divided there and the section removed.After attempts to locate the right side of the mesh in the groin compartment, this was discontinued, and the right side removed from the level of the obturator membrane as was done on the left side.A cystocele repair was then performed as a large paravaginal defect had been made during dissection.Postoperatively, pain control was adequate with oral hydromorphone.Condition was stable.Pathology report of specimen indicates fibroadipose tissue with foreign body-type giant cells and some mild chronic inflammation.On (b)(6) 2020, patient again underwent bilateral groin exploration with attempted mesh extraction.Following the mesh excision in (b)(6) 2019, the patient's right-sided obturator neuralgia symptoms continued and started to develop symptoms on the left side as well as groin pain radiating down both medial thighs, vaginal pain, and pain with sitting.Urinary complaints were minimal and there were no bowel complaints.Surgeon was unable to locate either piece of groin mesh.Diagnoses: postoperative obturator neuralgia, pudendal neuralgia and vaginal pain.Postoperatively, the patient had poor pain control for which pain medication was adjusted.A drg stimulator was also discussed as a potential treatment method moving forward.On (b)(6) 2020, the patient was evaluated at a pain management clinic for pain related to many reasons including cervical spine surgery x 3, mesh removal and infection that the patient felt was mismanaged, nerve pain in the pelvis that radiates to the back of her left leg and inside her right leg, rotator cuff issues that require surgery, "whole body arthritis" since childhood, lower back pain, and sciatica.She reported the following in association with the pain: bowel incontinence, numbness and tingling, balance problems, muscle weakness in her entire body, and sleep disturbances.Treatments had included chiropractic care, physical therapy, trigger point injections, tens unit, spinal injections, and narcotic pain medication.The patient's current medications included gabapentin and percocet.Treatment included oxycodone for low back pain, seroquel for major depressive disorder, plan to have ls spinal injections after shoulder surgery, and weight loss.On (b)(6) 2021, the patient presented to the emergency room for symptoms of suprapubic pressure and urinary frequency that started almost 2 weeks prior and had been treated with bactrim for 10 days without improvement.She also reported a history of frequent utis.Urinalysis showed no abnormalities.The patient was prescribed phenazopyridine.Additional information received on january 26, 2022.On (b)(6) 2019, patient presented for evaluation of continued dysuria.Patient stated she had a surgery scheduled in about two months to remove the implanted surgical mesh.Patient stated she has had increased pain in that area and has not had any real relief over the past couple of days.She adds she has noticed that her pain has gotten worse as well.Urinalysis showed 2+ blood.She was given ketorolac tromethamine 60mg/2ml and solu-medrol 125mg and referred to the urology service.On (b)(6) 2019, patient went for follow-up for continued abdominal pain.She had an extensive medical history related to bladder sling with complications.She had been treated several times for a uti.She was most recently treated with ciprofloxacin.The assessment was a urinary tract infection, and the patient was administered toradol 60mg and prescribed bactrim.On (b)(6) 2019, patient presented with continued bladder pain/pelvic pain.She noted that she was previously sent for a urology appointment but had not followed up yet.She stated she was in a lot of pain but did not want to go to the hospital for admission.The assessment was increased urinary frequency/polyuria, and cystocele/bladder prolapse.She was administered ketorolac tromethamine 60mg/2ml.She was referred to infectious disease for placement of a picc line to be given cefepime iv twice daily for 10 days.She was to continue follow up with infectious disease and urology as planned.Additional information received on march 23, 2022.On (b)(6) 2019, patient was evaluated for urinary incontinence.She reported being most bothered by severe leaking that has returned.She also reported urinary urgency and frequency, pain during urination, visible blood in the urine, difficulty starting her urine stream, and a sensation of incomplete bladder emptying.She also reported leakage of both solid and liquid stool and gas.She has been using vaginal estrogen for the vaginal atrophy but seemed to make her pain worse.During the visit, catheterization was performed to evaluate for incomplete emptying with finding of 10ml postvoid residual urine.The impression was stress urinary incontinence for which a pessary was fitted; obturator neuralgia s/p tot with subsequent partial excision for which the patient was referred for pelvic floor physical therapy (pfpt); and vaginal atrophy for which vaginal estrogen was prescribed.During a phone call on december 2, 2019, patient reported new stabbing-like pain on her right side that sometimes goes down her leg, sometimes up her flank ( she later said left side).This was a new pain on top of her chronic pain from the previously placed sling.Patient is taking tylenol; md recommends increasing her gabapentin dosage.Patient also reports some dysuria/bladder pain but that the pessary has improved her incontinence symptoms.Patient went for a follow-up visit on december 10, 2019 due to the same symptoms of neuralgia, severe atrophy and stress urinary incontinence (sui).Patient made succeeding follow-up visits on (b)(6), 2020, (b)(6) 2020 and (b)(6) 2020 for same symptoms (pain, sui).On (b)(6) 2020, patient underwent bilateral groin exploration surgery (no mesh was identified).Five days later, she fell while opening her horse trailer which resulted in postoperative wound dehiscence of her right groin and bleeding.She was seen in the emergency department the following day where ct scan showed subcutaneous soft tissue gas and edema within the perineum and medial thigh region (right greater than left).Home health was assigned to visit daily for wound care.On (b)(6) 2020, the patient was evaluated and reported continued drainage from her wound but did not have any packing in.Exam revealed the right groin wound had granulation tissue and exudate expected for ongoing healing and was without any evidence of active infection.The physician suspected a postop seroma may have been present that caused the dehiscence when the patient fell.The wound was cleaned and packed, the patient was started on augmentin, home health was to continue daily wound care, and the patient was referred to a physician with experience in groin area tumors to determine any further treatment.Additional information received on june 13, 2022.On (b)(6) 2019, the patient presented with complaints of abdominal pain and uti symptoms (dysuria with burning sensation) with onset four days ago.She reported that over the past few days after her mesh removal surgery a week ago, she developed dysuria associated with burning with urination.Abdominal pain, dysuria and urinary frequency were noted on her physical exam.During evaluation following treatment, the patient reported that she feels better.She was prescribed keflex and will pursue further outpatient evaluation.On (b)(6) 2019, she complained of severe lue (left upper extremity) pain after insertion of picc line that was performed on the same day.Reportedly, the pain radiates from her fingers up the extremity into the shoulder, the neck and the back of her head.She also reported tingling and numbness in her left hand.She noted being shaky and having a headache.She stated that she was fine until a picc line was placed for ic antibiotic therapy.She mentioned that she had a revision surgery performed but has retained infected parts of mesh that has resulted in a persistent inflammatory process/infection in her abdomen requiring the use of iv antibiotics for which the picc line was inserted.Imaging studies of the picc line were performed in the emergency department which revealed that the picc was in good placement.The ultrasound does not show any evidence of abnormality or dvt.However, since the patient was having intractable pain, she requested for picc line removal.Diagnostic studies: ultrasound of the left upper extremity interpreted as no evidence of dvt.Diagnoses: diagnoses, assessment and plan noted at that time: 1.Acute uti.Oral antibiotics failed.Cirtobacter freundii in urine noted.Patient was advised to start 1g cefepime iv every 12 hours for ten days.Okay to place midline.2.Lue pain after picc line insertion.Ultrasound revealed negative for dvt (deep vein thrombosis); however, dvt prophylaxis was given.Due to the patient's severity of pain and request for picc line removal, picc line will be removed.Patient was to be reevaluated in the morning for reinsertion of picc, possibly in the other upper extremity.To consultation with infection disease if needed for iv antibiotic therapy.Given the pain being in the patient's left arm and the radiating pain despite the absence of chest pain, it was decided to obtain serial cardiac enzymes and serial ekgs to exclude a cardiac component.The patient can resume cefepime iv once midline has been placed.On revaluation: tramadol was ordered as the patient requested pain medications at bedside.The patient felt better and pain had improved.She was admitted for observation.Additional information received on july 25, 2022.On (b)(6) 2020, the patient presented with complaints of burning, urinary frequency, bladder pain and possible mrsa (methicillin-resistant staphylococcus aureus).She reported having four boils in her inner thighs near her groin which she suspected due to mrsa.She was concerned about mrsa due to a procedure to remove the remainder of a bladder sling in (b)(6) 2020 and having a difficult time with wounds healing.Review of systems: genitourinary: frequency, painful urination, bladder pain.Assessments: 1.Uti (urinary tract infection), uncomplicated.2.Encounter for screening.3.Body mass index (bmi) of 32.0-32.9 in adult.4.Boils near inner thighs.5.Herpes.Treatment: 1.Uti (urinary tract infection), uncomplicated.Lab: chlamydia/n.Gonorrhoeae rna, tma, urogenital.Lab: culture, urine, routine.

Manufacturer Narrative

Additional information: blocks b5 and h6: patient codes patient codes e172001, e1901, e1707 and e1705 have been added.Block b3 date of event: date of event was approximated to (b)(6) 2019 (initial clinic visit postoperatively) as no event date was reported.Block e1: patient's other lawyers: (b)(6) pllc.(b)(6).Tel #: (b)(6).Fax #: (b)(6).(b)(6).(b)(6).The device was implanted: (b)(6 hospital.Implanting surgeon: dr.(b)(6).Assisted by dr.(b)(6), ((b)(6) hospital).Attempted mesh excision/extraction: dr.(b)(6), ((b)(6) hospital).Bilateral groin exploration surgery: dr.(b)(6), ((b)(6)).Block h6: the patient codes below capture the following reportable events: e1405 - dyspareunia.E1715 - scarring.E1301 - dysuria.E1309 - urinary retention.E1023 - nerve injuries.E2326 - inflammation.E0506 - vaginal bleeding.E2330 - pain.E1002 - abdominal pain.E1310 - urinary tract infection.E2340 - wound dehiscence.E172001 - boils.E1901 - mrsa.E1707 - difficulty with wound healing.Impact codes f19, f2303, f08, f1905 and f1202 capture the reportable events of attempted mesh removal/extraction and medications required, as well as additional surgery (groin exploration), prolonged hospital stay, mesh revision.Block h10: the complaint device is not expected to be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

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Brand Name

OBTRYX II SYSTEM - CURVED

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

9538551

MDR Text Key

177365527

Report Number

3005099803-2019-06296

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729839255

UDI-Public

08714729839255

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K121754

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/22/2022

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?

Device Operator

Health Professional

Device Expiration Date

06/12/2020

Device Model Number

M0068504110

Device Catalogue Number

850-411

Device Lot Number

0020762960

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

12/08/2019

Initial Date FDA Received

01/02/2020

Supplement Dates Manufacturer Received

01/14/2022
03/23/2022
06/13/2022
07/25/2022

Supplement Dates FDA Received

02/11/2022
04/19/2022
07/07/2022
08/22/2022

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

06/13/2017

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

59 YR

Patient Sex

Female

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

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