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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068502110 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Wound Dehiscence (1154); Adhesion(s) (1695); Diarrhea (1811); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Sepsis (2067); Urinary Retention (2119); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Weight Changes (2607); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 08/07/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2015, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This was reported by the patient's legal representation.The device was implanted at (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.
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Event Description
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It was reported to boston scientific corporation that an advantage fit device was implanted into the patient during a procedure performed on (b)(6) 2015.As per reported by the patient's attorney, after the implantation, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Event Description
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It was reported to boston scientific corporation that an advantage fit device was implanted during a total robotic hysterectomy with bilateral salpingo-oophorectomy + robotic lysis of omental adhesions + tvt urethral sling with cystoscopy procedure performed on (b)(6) 2015 for the treatment of chronic pelvic pain, ovarian cyst, uteromegaly and urinary incontinence.On (b)(6) 2018, the patient was reported to have experienced bladder mass, vaginal pain and urinary problem.Patient had a long history of multiple visits to the er with pain and anxiety.During this visit, patient complained of generalized pain, urinary incontinence related to mesh suspension three years ago.Chief complaint of pain and incontinence and additional complaint of muscle weakness.The patient was then given medications and ambulatory referral to urogynecology.
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Manufacturer Narrative
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Additional information: a2: dob, a4, b3, b5, h6: patient codes and impact codes.Block b3 date of event: date of event was approximated to (b)(6) 2018, the date patient had a follow up visit due to symptoms.Blocks d4, h4: the lot number (ml000026117) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1: this was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e2330 captures the reportable event of pain.Block h10: the complaint device is implanted and 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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Event Description
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It was reported that an advantage fit device was implanted during a total robotic hysterectomy with bilateral salpingo-oophorectomy + robotic lysis of omental adhesions + tvt urethral sling with cystoscopy procedure performed on (b)(6) 2015 for the treatment of chronic pelvic pain, ovarian cyst, uteromegaly and urinary incontinence.On (b)(6) 2018, the patient was reported to have experienced bladder mass, vaginal pain and urinary problem.Patient had a long history of multiple visits to the er with pain and anxiety.During this visit, patient complained of generalized pain, urinary incontinence related to mesh suspension three years ago.Chief complaint of pain and incontinence and additional complaint of muscle weakness.The patient was then given medications and ambulatory referral to urogynecology.*additional information received on march 23, 2022.On (b)(6) 2022, the patient had complete mesh excision during a vaginal mesh removal, bilateral groin exploration with mesh removal laparotomy exploratory, urethroperineal mesh removal procedure.Prior to the procedure, the patient was diagnosed with pudendal neuralgia and obturator neuralgia due to mesh insertion in 2015.Since the implant, the patient has been complaining of shooting pains with pins and needles sensation radiating down both inner thighs, vaginal pain and clitoral pain, pelvic pain, some weakness and difficulty with ambulation, slow voiding with some urinary leakage.The patient also claimed to experience urinary frequency with urgency, loose bowel movements up to four to five times per day and occasional dyschezia.The patient could not have sex secondary to her pain complaints, and significant pain with sitting.The patient was also advised that tissue fixation from the mesh itself with inflammation can also cause pain complaints.On physical examination, the patient had positive point tenderness along the inferior pubic rami.Positive skin rolling sensitivity along the medial thighs bilaterally.The vagina showed the levator plate is tender to palpation especially toward the sacrospinous ligament complexes and the ischial spines.The mesh itself was quite tender, especially as it perforated the obturator internus muscle.The bladder was mildly tender.During the mesh removal surgery, it was found that the mesh on the right side was extremely adherent to the urethra and the mesh on the left was perforating the rectus fascia.It was not adherent to the bone but more so the paravesical tissue.The entire mesh was removed.The patient was brought to recovery room awake, alert and in apparent stable condition.No complications reported.
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Manufacturer Narrative
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Additional information: a1, b5, b6, d6b, h6: patient code and impact code.Block b3 date of event: date of event was approximated to august 7, 2018, the date patient had a follow up visit due to symptoms.Blocks d4, h4: the lot number (ml000026117) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1: this was reported by the patient's legal representation.The implant surgeon is: (b)(6).Mesh removal surgeon is: (b)(6).Block h6: patient codes e2330, e2101, e2114, e1309, e1405, e0123 and e2401 capture the reportable events of pain (shooting pains with pins and needles sensation, vaginal pain, clitoral pain, significant pain with sitting, pelvic pain, bladder being tender to palpation), mesh was extremely adherent to the urethra and paravesical tissue, perforates the obturator internus muscle and the rectus fascia, slow voiding, bladder is mildly tender, cannot have sex, pudendal neuralgia and obturator neuralgia and difficulty with ambulation.Impact codes f1903 and f2303 capture the reportable events of complete mesh remoal and medications taken.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.
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Event Description
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It was reported that an advantage fit device was implanted during a total robotic hysterectomy with bilateral salpingo-oophorectomy + robotic lysis of omental adhesions + tvt urethral sling with cystoscopy procedure performed on (b)(6) 2015 for the treatment of chronic pelvic pain, ovarian cyst, uteromegaly and urinary incontinence.On (b)(6) 2018, the patient was reported to have experienced bladder mass, vaginal pain and urinary problem.Patient had a long history of multiple visits to the er with pain and anxiety.During this visit, patient complained of generalized pain, urinary incontinence related to mesh suspension three years ago.Chief complaint of pain and incontinence and additional complaint of muscle weakness.The patient was then given medications and ambulatory referral to urogynecology.*additional information received on 23mar2022 provides the below information: on (b)(6) 2022, the patient had complete mesh excision during a vaginal mesh removal, bilateral groin exploration with mesh removal laparotomy exploratory, retroperineal mesh removal procedure.Prior to the procedure, the patient was diagnosed with pudendal neuralgia and obturator neuralgia due to mesh insertion in 2015.Since the implant, the patient has been complaining of shooting pains with pins and needles sensation radiating down both inner thighs, vaginal pain and clitoral pain, pelvic pain, some weakness and difficulty with ambulation, slow voiding with some urinary leakage.The patient also claimed to experience urinary frequency with urgency, loose bowel movements up to four to five times per day and occasional dyschezia.The patient could not have sex secondary to her pain complaints, and significant pain with sitting.The patient was also advised that tissue fixation from the mesh itself with inflammation can also cause pain complaints.On physical examination, the patient had positive point tenderness along the inferior pubic rami.Positive skin rolling sensitivity along the medial thighs bilaterally.The vagina showed the levator plate is tender to palpation especially toward the sacrospinous ligament complexes and the ischial spines.The mesh itself was quite tender, especially as it perforated the obturator internus muscle.The bladder was mildly tender.During the mesh removal surgery, it was found that the mesh on the right side was extremely adherent to the urethra and the mesh on the left was perforating the rectus fascia.It was not adherent to the bone but more so the paravesical tissue.The entire mesh was removed.The patient was brought to recovery room awake, alert and in apparent stable condition.No complications reported.*additional information received on july 5, 2022: in march 2018, cervical x-rays showed degenerative changes with disc height narrowing and neural formina narrowing at c5-c6 and c6-c7; atherosclerotic changes were noted projected over the carotid arterial systems (r>l).In may 2019, cervical mri showed multilevel degenerative changes, most advanced c5-c6 and c6-c7 with acute on chronic marrow changes, mild to moderate central canal narrowing and bilateral moderate to severe foraminal narrowing.Lumbar x-ray in august 2019 showed degenerative changes seen with mild levoscoliosis, and mild loss of disc height with endplate spondylitic spurring and mild neural foraminal narrowing at l5-s1.In august 2019, the patient had an initial pain evaluation consult.Her chief complaint was cervical pains.That radiated into bilateral shoulders and some radicular pains extending down the left arm and causing tingling in her fingers.These had a gradual onset with worsening pain beginning in 2015.The pain was daily and constant and described as burning, shooting, aching, and cramping.Secondary complaints were various joint pains including her lumbar spine, knees, hands, shoulders, and sacrum.She reported a history of lupus and ra.Her lumbar pains have worsened within the past year.Also reported some tingling and burning radicular type pains extending down the leg anteriorly to the ankle in a non dermatomal fashion.She had been treated with plaquenil for 2 years but stopped due to vision problems.Her pain had been managed with gabapentin and norco.In october 2019, lumbar mri showed mild spondylosis at l5 and l4 with minimal posterior bulge at l3 and mild facet osteoarthropathy at l5-s1.On december 28, 2021, the patient was seen for follow-up regarding her chronic pain.She reported unchanged pain in her neck and low back, increased cramping pain in her legs for which she would restart gabapentin and stop ropinirole.She reported a planned surgery related to her bladder sling that she suspected was causing some of her pain.The assessment included cervical radicular pain, cervical spondylosis, neck muscle pain, and restless leg syndrome.The patient's medications were reviewed and adjusted as needed.An office visit on january 5, 2022 revealed that the patient had a medical history of anxiety, chronic pain, depression and hypertension.In (b)(6), status post mesh excision on (b)(6), 2022, the patient was doing relatively well, no urinary or bowel complaints, pain was well managed with medication and pain relief regarding pre-existing pain complaints.However, on (b)(6) 2022, patient claimed that two weeks after the surgical intervention, her incision opened up and was infected.Had to stay in the icu for five days and hospitalized for a total of eight days due to sepsis.The patient went home middle of january but had to go back to hospital in march for five days due to another infection at the incision site.She lost weight from january and currently taking flagyl and doxy.Additional information received on 28jul2022.The patient presents with difficulty breathing.Other than respiratory symptoms, the patient reports bladder mesh done in 2013 and thinks her body is rejecting it.Patient also reports bladder mesh placed in 01/2016 and has been in and out of the hospital since the surgery for various symptoms related to her bladder mesh.Her primary doctor has been evaluating her bladder mesh and the associated symptoms for the last 3 years, and office visits over 60 times.Patient reports "feels like i'm fighting death".
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Manufacturer Narrative
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Additional information: blocks b5, b7and h6: impact code block b3 date of event: date of event was approximated to january 5, 2015, the implant date based on the information that the patient reported gradual onset with worsening pain beginning in 2015.Blocks d4, h4: the lot number (ml000026117) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1: this was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient codes e2330, e2101, e2114, e1309, e1405, e0123, e2401,e1906, e0306 and e2340 capture the reportable events of pain (shooting pains with pins and needles sensation, vaginal pain, clitoral pain, significant pain with sitting, pelvic pain, bladder being tender to palpation), mesh was extremely adherent to the urethra and paravesical tissue, perforates the obturator internus muscle and the rectus fascia, slow voiding, bladder is mildly tender, cannot have sex, pudendal neuralgia and obturator neuralgia and difficulty with ambulation, incision opened up and was infected and sepsis.Impact codes f1903,f2303, f08 and f1901 capture the reportable events of complete mesh removal, medications taken and icu for 5 days and was in the hospital a total of 8 days due to sepsis; back to the hospital for 5 days due to another infection and bladder mesh implanted in january 2016 post device implant.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.
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Event Description
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It was reported that an advantage fit device was implanted during a total robotic hysterectomy with bilateral salpingo-oophorectomy + robotic lysis of omental adhesions + tvt urethral sling with cystoscopy procedure performed on january 5, 2015 for the treatment of chronic pelvic pain, ovarian cyst, uteromegaly and urinary incontinence.On (b)(6), 2018, the patient was reported to have experienced bladder mass, vaginal pain and urinary problem.Patient had a long history of multiple visits to the er with pain and anxiety.During this visit, patient complained of generalized pain, urinary incontinence related to mesh suspension three years ago.Chief complaint of pain and incontinence and additional complaint of muscle weakness.The patient was then given medications and ambulatory referral to urogynecology.*additional information received on 23mar2022 provides the below information: on (b)(6), 2022, the patient had complete mesh excision during a vaginal mesh removal, bilateral groin exploration with mesh removal laparotomy exploratory, retroperineal mesh removal procedure.Prior to the procedure, the patient was diagnosed with pudendal neuralgia and obturator neuralgia due to mesh insertion in 2015.Since the implant, the patient has been complaining of shooting pains with pins and needles sensation radiating down both inner thighs, vaginal pain and clitoral pain, pelvic pain, some weakness and difficulty with ambulation, slow voiding with some urinary leakage.The patient also claimed to experience urinary frequency with urgency, loose bowel movements up to four to five times per day and occasional dyschezia.The patient could not have sex secondary to her pain complaints, and significant pain with sitting.The patient was also advised that tissue fixation from the mesh itself with inflammation can also cause pain complaints.On physical examination, the patient had positive point tenderness along the inferior pubic rami.Positive skin rolling sensitivity along the medial thighs bilaterally.The vagina showed the levator plate is tender to palpation especially toward the sacrospinous ligament complexes and the ischial spines.The mesh itself was quite tender, especially as it perforated the obturator internus muscle.The bladder was mildly tender.During the mesh removal surgery, it was found that the mesh on the right side was extremely adherent to the urethra and the mesh on the left was perforating the rectus fascia.It was not adherent to the bone but more so the paravesical tissue.The entire mesh was removed.The patient was brought to recovery room awake, alert and in apparent stable condition.No complications reported.*additional information received on july 5, 2022: in (b)(6) 2018, cervical x-rays showed degenerative changes with disc height narrowing and neural formina narrowing at c5-c6 and c6-c7; atherosclerotic changes were noted projected over the carotid arterial systems (r>l).In (b)(6) 2019, cervical mri showed multilevel degenerative changes, most advanced c5-c6 and c6-c7 with acute on chronic marrow changes, mild to moderate central canal narrowing and bilateral moderate to severe foraminal narrowing.Lumbar x-ray in august 2019 showed degenerative changes seen with mild levoscoliosis, and mild loss of disc height with endplate spondylitic spurring and mild neural foraminal narrowing at l5-s1.In (b)(6) 2019, the patient had an initial pain evaluation consult.Her chief complaint was cervical pains.That radiated into bilateral shoulders and some radicular pains extending down the left arm and causing tingling in her fingers.These had a gradual onset with worsening pain beginning in 2015.The pain was daily and constant and described as burning, shooting, aching, and cramping.Secondary complaints were various joint pains including her lumbar spine, knees, hands, shoulders, and sacrum.She reported a history of lupus and ra.Her lumbar pains have worsened within the past year.Also reported some tingling and burning radicular type pains extending down the leg anteriorly to the ankle in a non dermatomal fashion.She had been treated with plaquenil for 2 years but stopped due to vision problems.Her pain had been managed with gabapentin and norco.In (b)(6) 2019, lumbar mri showed mild spondylosis at l5 and l4 with minimal posterior bulge at l3 and mild facet osteoarthropathy at l5-s1.On (b)(6) 28, 2021, the patient was seen for follow-up regarding her chronic pain.She reported unchanged pain in her neck and low back, increased cramping pain in her legs for which she would restart gabapentin and stop ropinirole.She reported a planned surgery related to her bladder sling that she suspected was causing some of her pain.The assessment included cervical radicular pain, cervical spondylosis, neck muscle pain, and restless leg syndrome.The patient's medications were reviewed and adjusted as needed.An office visit on (b)(6), 2022 revealed that the patient had a medical history of anxiety, chronic pain, depression and hypertension.In (b)(6), status post mesh excision on (b)(6), 2022, the patient was doing relatively well, no urinary or bowel complaints, pain was well managed with medication and pain relief regarding pre-existing pain complaints.However, on (b)(6) 2022, patient claimed that two weeks after the surgical intervention, her incision opened up and was infected.Had to stay in the icu for five days and hospitalized for a total of eight days due to sepsis.The patient went home middle of january but had to go back to hospital in (b)(6) for five days due to another infection at the incision site.She lost weight from (b)(6) and currently taking flagyl and doxy.
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Manufacturer Narrative
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Block b3 date of event:
date of event was approximated to january 5, 2015, the implant date based on the information that the patient reported gradual onset with worsening pain beginning in 2015.Blocks d4, h4:
the lot number (ml000026117) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.Block e1:
this was reported by the patient's legal representation.The implant surgeon is:
dr.James t.Nunally
parkridge east hospital
chattanooga, tn 37412
mesh removal surgeon is:
dr.Mark conway
st.Joseph hospital of nashua
172 kinsley st.,
nashua, nh 03060-3648
block h6:
patient codes e2330, e2101, e2114, e1309, e1405, e0123, e2401,e1906, e0306 and e2340
capture the reportable events of pain (shooting pains with pins and needles sensation, vaginal pain, clitoral pain, significant pain with sitting, pelvic pain, bladder being tender to palpation), mesh was extremely adherent to the urethra and paravesical tissue, perforates the obturator internus muscle and the rectus fascia, slow voiding, bladder is mildly tender, cannot have sex, pudendal neuralgia and obturator neuralgia and difficulty with ambulation, incision opened up and was infected and sepsis.Impact codes f1903,f2303 and f08 capture the reportable events of complete mesh removal, medications taken and icu for 5 days and was in the hospital a total of 8 days due to sepsis; and back to the hospital for 5 days due to another infection.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10:
the removed mesh 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.
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