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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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| Model Number M0068507000 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
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| Patient Problems
Adhesion(s) (1695); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684); Movement Disorder (4412); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 04/20/2016 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant facility 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.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant facility 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.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant facility is: (b)(6) block h6: patient code e2401 captures the reportable event of unknown injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: blocks a2, a3, b2, b5, h2, h6 and h10 have been updated based on the additional information received on september 23, 2022.Blocks e1 and g2 have been corrected.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(6) block h6: patient code e1301 captures the reportable events of "pain or burning sensation when urinating," and "burning sensation when she urinates." patient code e1309 captures the reportable event of "currently having trouble urinating." patient code e1310 captures the reportable events of "urinary tract infection," and "recurrent urinary tract infections since sling placement in 2016." patient code e2326 captures the reportable event of "interstitial cystitis of the bladder." patient code e0506 captures the reportable events of "hemorrhagic areas within the bladder," "hemorrhagic patch," and "multiple areas of hemorrhage within the bladder wall." patient code e2338 captures the reportable event of "erythema of the posterior bladder wall above the trigone." patient code e2101 captures the reportable events of "filmy pelvic adhesions," and "filmy adhesions of the sigmoid colon to the posterior vagina and cecum to the right lateral abdominal wall." patient code e2330 captures the reportable events of "pelvic pain on both sides," "supra pubic pain," "chronic pelvic pain," and "tenderness when pressing on the sling transvaginally." patient code e1405 captures the reportable event of "dyspareunia." impact code f1901 captures the reportable event of additional surgeries performed.Impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2016.As reported by the patient's attorney, the patient experienced an unknown injury.***additional information received on september 23, 2022*** the procedure performed on (b)(6) 2016 were total laparoscopic hysterectomy with bilateral salpingo-oophorectomy, an extensive enterolysis (45 additional minutes were required to lyse the adhesions.The cul-de-sac was obliterated and both ovaries were densely adherent to the sigmoid colon and lateral pelvis and uterus), solyx mid urethral synthetic sling placement, and cystoscopy procedures to treat a patient with a history of polycystic ovarian syndrome, adenomyosis, a left ovarian complex cyst, pelvic pain, uterine fibroids, and stress urinary incontinence.Of note, the patient had a rising ca-125 titer, but her roma test was normal, low probability of malignancy for a premenopausal patient.She had been tried on conservative management including medications and was using kegel's and other modalities for her bladder to no avail.Operative findings include a normal appendix, bilateral ovarian endometriomas with adhesions to the cul-de-sac, lateral pelvis and sigmoid colon on both sides, and uterus.The cul-de-sac was obliterated with dense adhesions.There were dense sigmoid adhesions.There was adenomyosis of the uterus.The bladder was normal.There were no complications from this procedure and the patient condition at the conclusion of the procedures was stable.On (b)(6) 2019, the patient was experienced dyspareunia and pelvic pain.The patient was unresponsive to conservative management.Of note, she had a positive questionnaire for interstitial cystitis.Her post operative diagnosis included filmy pelvic adhesions, interstitial cystitis of the bladder.The patient underwent a laparoscopy, lysis of adhesions, cystoscopy, hydrodistention of the bladder, instillation of bladder medications (the cocktail of sterile water heparin 40,000 units, kenalog 40 mg, lidocaine 1% 8 cc, 8.4% sodium bicarbonate, 8 cc was instilled at the end of the procedure) procedures.During the procedure, following all appropriate laboratories and consents, the patient was brought to the operating theater.She underwent an uneventful anesthesia immersion.A time-out was performed in the room.The patient received perioperative antibiotics of 2 g of ancef intravenously.The abdomen and vagina were prepped and draped in the customary fashion for laparoscopic and vaginal surgery.A foley catheter was placed.The patient was placed in the protected stirrups and moved to modified dorsal lithotomy position.The infraumbilical margin was selected as an entry point for laparoscopy.This area was injected with 0.5% marcaine with epinephrine, the periumbilical area was elevated with traumatic towel clamps and 5-mm ethicon visualizing tip trocar with the attached laparoscope and camera was used to enter the abdominal cavity on the first attempt.Carbon dioxide gas was used to insufflate the abdomen and secondary punctures were made in the right and left lower quadrants after injection of the skin with local anesthetic of 0.5% marcaine with epinephrine.These were 5-mm applied balloon tip trocars.The previously described findings of small amount of filmy adhesions of the rectosigmoid to the right posterior vagina and right pelvic sidewall were identified and atraumatic bowel grasper was used to the right lower quadrant trocar site to reflect the bowel to the left and cold dissection with scissors with sharp scissors was used to lyse the filmy adhesions uneventfully with care taken to avoid the bowel the area of the cecum was also retracted medially from the right side and the few small adhesions in this location were removed as well without difficulty.This ended the laparoscopic portion of the case.All carbon-dioxide was removed.All the surgical sites were inspected and found to be hemostatic.All fluid and debris was removed.The trocar sleeves were removed under direct visualization as well as residual bleeding from the trocar sleeve sites.The skin incisions were all reinjected with local anesthetic and closed with #4-0 monocryl suture.Attention was then turned to the bladder.A 0-degree rigid cystoscope was used to investigate the bladder on the right posterior bladder wall.Upon entry it was noted that there was a hemorrhagic patch and there was erythema of the posterior bladder wall above the trigone.1000 cc of sterile water was introduced into the bladder and remained in place for five minutes.The fluid was then subsequently drained and the bladder wall was inspected.There were multiple areas of hemorrhage within the bladder wall following the placement of the sterile water and these areas were indicative of interstitial cystitis.Decision was made to proceed with instillation of the bladder cocktail with heparin, kenalog, lidocaine and sodium bicarbonate in the previously described amounts.This solution and 500 cc of sterile water was instilled into the bladder and the foley was replaced.The patient was sent to the recovery room with the foley in place and will leave the bladder cocktail in the bladder for approximately 30 minutes in recovery.The patient was stable.There were no complications.She was transferred to the recovery area in satisfactory condition.On (b)(6) 2021, the patient was seen and examined for pelvic pain on both sides.She reportedly experienced pain or burning sensation when urinating.She first noticed the symptom approximately on (b)(6) 2016.She reported to strain or bear down to start her urinary stream.The patient also had urinary tract infection.The patient has had recurrent urinary tract infections since sling placement in 2016.The patient also reported to have interstitial cystitis and was currently having trouble urinating.She reported a burning sensation when she urinates.The patient was also having problems with urinary control or incontinence.She was incontinent immediately following the strong urge to urinate.The patient had hysterectomy and a sling (4/2016) for stress incontinence.Things seemed to improve for a few weeks but then supra pubic pain began and it has been consistent.The physician has done hyperdistention and cystoscopy in december 2009.She has had several urinary tract infections (utis) but hasn't had any since last year.The patient stated that she had no symptoms prior to the sling implant however, the patient is experiencing fibromyalgia and endometriosis.She was also having some back issues and has been referred to a physician her appointments done in november.When the patient was constipated, it was difficult to urinate.On occasion, she has leaked with urgency.She said she would rather wear a pad the rest of her life instead of having the bladder pain she has now.The patient underwent a flexible cystoscopy.The risks benefits, and some of the potential complications of the procedure were discussed at length with the patient.Including infection, bleeding, voiding discomfort, urinary retention, fever, chills, sepsis, and others.All questions were answered.Informed consent was obtained.Antibiotic prophylaxis was given.Sterile technique and intraurethral analgesia were used.The procedure revealed a normal size, location and condition of the meatus.The urethra was tender.The ureteral orifices were in normal location, size and shape.Effluxed clear urine.The bladder had no trobeculation, tumor, nor stone.The mucosa was also normal.The lower urinary tract was carefully examined.The procedure was well tolerated and without complications.Antibiotic instructions were given.Instructions were given to call the office immediately for bloody urine, difficulty urinating, urinary retention, painful or frequent urination.Fever, chills, nausea, vomiting or other illness.The patient stated that she understood these instructions and would comply with them.The patient was also scheduled for urethrolysis.On (b)(6) 2021, the patient was scheduled for urethrolysis.On pelvic exam, she did have tenderness when pressing on the sling transvaginally.They discussed the option of cutting the sling to remove the tension to hopefully help reduce her abdominal pain.They also discussed the possibility of recurrent stress incontinence.Her quality of life has suffered and her primary goals are to try and get rid of her pain, even if she has to start wearing pads again.Today, the physician planned urethrolysis.During the procedure, after informed consent was obtained, the patient was taken to the operating room after receiving a preoperative dose of antibiotics.She was given a general anesthetic and placed in the dorsal lithotomy position.Her genitals were prepped and draped in usual sterile fashion.The physician placed a #16-french catheter through the urethra into the bladder.The physician injected 20 cc of normal saline into the right lateral vaginal sulcus for hydrodissection.Using a #15 blade, the physician made an incision in the anterior vaginal wall near the sulcus.The physician carefully dissected beneath the mucosa and through the vagina, and the physician carefully dissected through and identified and mobilized the mesh.The physician cut the pseudocapsule from around the polypropylene mesh.The physician cut out about a 2 cm segment.When the physician cut the sling, all the tension that was felt with the sling was relieved.The urethra became certainly more mobile.The physician left the sling immediately under the urethra to hopefully reduce her pain, but yet still have some continence.The physician obtained hemostasis and closed the vaginal incision with a running #2-0 vicryl stitch.The patient tolerated the procedure well.There were no apparent complications.She was extubated and brought to the recovery room in good condition.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code e1301 captures the reportable events of "pain or burning sensation when urinating," and "burning sensation when she urinates." patient code e1309 captures the reportable event of "currently having trouble urinating." patient code e1310 captures the reportable events of "urinary tract infection," and "recurrent urinary tract infections since sling placement in 2016." patient code e2326 captures the reportable event of "interstitial cystitis of the bladder and and erythema of the posterior bladder wall above the trigone." patient code e0506 captures the reportable events of "hemorrhagic areas within the bladder," "hemorrhagic patch," and "multiple areas of hemorrhage within the bladder wall." patient code e1715: scar tissue (cicatrix) captures the reportable event of psuedocapsule.Patient code e2101 captures the reportable events of "filmy pelvic adhesions," and "filmy adhesions of the sigmoid colon to the posterior vagina and cecum to the right lateral abdominal wall." patient code e2330 captures the reportable events of "pelvic pain on both sides," "supra pubic pain," "chronic pelvic pain," and "tenderness when pressing on the sling transvaginally." patient code e1405 captures the reportable event of "dyspareunia." impact code f1901 captures the reportable event of additional surgeries performed.Impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block h6: device codes and patient codes have been corrected.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6), 2016.As reported by the patient's attorney, the patient experienced an unknown injury.***additional information received on (b)(6) 2022*** the procedure performed on (b)(6) 2016 were total laparoscopic hysterectomy with bilateral salpingo-oophorectomy, an extensive enterolysis (45 additional minutes were required to lyse the adhesions.The cul-de-sac was obliterated and both ovaries were densely adherent to the sigmoid colon and lateral pelvis and uterus), solyx mid urethral synthetic sling placement, and cystoscopy procedures to treat a patient with a history of polycystic ovarian syndrome, adenomyosis, a left ovarian complex cyst, pelvic pain, uterine fibroids, and stress urinary incontinence.Of note, the patient had a rising ca-125 titer, but her roma test was normal, low probability of malignancy for a premenopausal patient.She had been tried on conservative management including medications and was using kegel's and other modalities for her bladder to no avail.Operative findings include a normal appendix, bilateral ovarian endometriomas with adhesions to the cul-de-sac, lateral pelvis and sigmoid colon on both sides, and uterus.The cul-de-sac was obliterated with dense adhesions.There were dense sigmoid adhesions.There was adenomyosis of the uterus.The bladder was normal.There were no complications from this procedure and the patient condition at the conclusion of the procedures was stable.On (b)(6) 2019, the patient was experienced dyspareunia and pelvic pain.The patient was unresponsive to conservative management.Of note, she had a positive questionnaire for interstitial cystitis.Her post operative diagnosis included filmy pelvic adhesions, interstitial cystitis of the bladder.The patient underwent a laparoscopy, lysis of adhesions, cystoscopy, hydrodistention of the bladder, instillation of bladder medications (the cocktail of sterile water heparin 40,000 units, kenalog 40 mg, lidocaine 1% 8 cc, 8.4% sodium bicarbonate, 8 cc was instilled at the end of the procedure) procedures.During the procedure, following all appropriate laboratories and consents, the patient was brought to the operating theater.She underwent an uneventful anesthesia immersion.A time-out was performed in the room.The patient received perioperative antibiotics of 2 g of ancef intravenously.The abdomen and vagina were prepped and draped in the customary fashion for laparoscopic and vaginal surgery.A foley catheter was placed.The patient was placed in the protected stirrups and moved to modified dorsal lithotomy position.The infraumbilical margin was selected as an entry point for laparoscopy.This area was injected with 0.5% marcaine with epinephrine, the periumbilical area was elevated with traumatic towel clamps and 5-mm ethicon visualizing tip trocar with the attached laparoscope and camera was used to enter the abdominal cavity on the first attempt.Carbon dioxide gas was used to insufflate the abdomen and secondary punctures were made in the right and left lower quadrants after injection of the skin with local anesthetic of 0.5% marcaine with epinephrine.These were 5-mm applied balloon tip trocars.The previously described findings of small amount of filmy adhesions of the rectosigmoid to the right posterior vagina and right pelvic sidewall were identified and atraumatic bowel grasper was used to the right lower quadrant trocar site to reflect the bowel to the left and cold dissection with scissors with sharp scissors was used to lyse the filmy adhesions uneventfully with care taken to avoid the bowel the area of the cecum was also retracted medially from the right side and the few small adhesions in this location were removed as well without difficulty.This ended the laparoscopic portion of the case.All carbon-dioxide was removed.All the surgical sites were inspected and found to be hemostatic.All fluid and debris was removed.The trocar sleeves were removed under direct visualization as well as residual bleeding from the trocar sleeve sites.The skin incisions were all reinjected with local anesthetic and closed with #4-0 monocryl suture.Attention was then turned to the bladder.A 0-degree rigid cystoscope was used to investigate the bladder on the right posterior bladder wall.Upon entry it was noted that there was a hemorrhagic patch and there was erythema of the posterior bladder wall above the trigone.1000 cc of sterile water was introduced into the bladder and remained in place for five minutes.The fluid was then subsequently drained and the bladder wall was inspected.There were multiple areas of hemorrhage within the bladder wall following the placement of the sterile water and these areas were indicative of interstitial cystitis.Decision was made to proceed with instillation of the bladder cocktail with heparin, kenalog, lidocaine and sodium bicarbonate in the previously described amounts.This solution and 500 cc of sterile water was instilled into the bladder and the foley was replaced.The patient was sent to the recovery room with the foley in place and will leave the bladder cocktail in the bladder for approximately 30 minutes in recovery.The patient was stable.There were no complications.She was transferred to the recovery area in satisfactory condition.On (b)(6) 2021, the patient was seen and examined for pelvic pain on both sides.She reportedly experienced pain or burning sensation when urinating.She first noticed the symptom approximately on (b)(6) 2016.She reported to strain or bear down to start her urinary stream.The patient also had urinary tract infection.The patient has had recurrent urinary tract infections since sling placement in 2016.The patient also reported to have interstitial cystitis and was currently having trouble urinating.She reported a burning sensation when she urinates.The patient was also having problems with urinary control or incontinence.She was incontinent immediately following the strong urge to urinate.The patient had hysterectomy and a sling (4/2016) for stress incontinence.Things seemed to improve for a few weeks but then supra pubic pain began and it has been consistent.The physician has done hyperdistention and cystoscopy in december 2009.She has had several urinary tract infections (utis) but hasn't had any since last year.The patient stated that she had no symptoms prior to the sling implant however, the patient is experiencing fibromyalgia and endometriosis.She was also having some back issues and has been referred to a physician her appointments done in november.When the patient was constipated, it was difficult to urinate.On occasion, she has leaked with urgency.She said she would rather wear a pad the rest of her life instead of having the bladder pain she has now.The patient underwent a flexible cystoscopy.The risks benefits, and some of the potential complications of the procedure were discussed at length with the patient.Including infection, bleeding, voiding discomfort, urinary retention, fever, chills, sepsis, and others.All questions were answered.Informed consent was obtained.Antibiotic prophylaxis was given.Sterile technique and intraurethral analgesia were used.The procedure revealed a normal size, location and condition of the meatus.The urethra was tender.The ureteral orifices were in normal location, size and shape.Effluxed clear urine.The bladder had no trobeculation, tumor, nor stone.The mucosa was also normal.The lower urinary tract was carefully examined.The procedure was well tolerated and without complications.Antibiotic instructions were given.Instructions were given to call the office immediately for bloody urine, difficulty urinating, urinary retention, painful or frequent urination.Fever, chills, nausea, vomiting or other illness.The patient stated that she understood these instructions and would comply with them.The patient was also scheduled for urethrolysis.On (b)(6) 2021, the patient was scheduled for urethrolysis.On pelvic exam, she did have tenderness when pressing on the sling transvaginally.They discussed the option of cutting the sling to remove the tension to hopefully help reduce her abdominal pain.They also discussed the possibility of recurrent stress incontinence.Her quality of life has suffered and her primary goals are to try and get rid of her pain, even if she has to start wearing pads again.Today, the physician planned urethrolysis.During the procedure, after informed consent was obtained, the patient was taken to the operating room after receiving a preoperative dose of antibiotics.She was given a general anesthetic and placed in the dorsal lithotomy position.Her genitals were prepped and draped in usual sterile fashion.The physician placed a #16-french catheter through the urethra into the bladder.The physician injected 20 cc of normal saline into the right lateral vaginal sulcus for hydrodissection.Using a #15 blade, the physician made an incision in the anterior vaginal wall near the sulcus.The physician carefully dissected beneath the mucosa and through the vagina, and the physician carefully dissected through and identified and mobilized the mesh.The physician cut the pseudocapsule from around the polypropylene mesh.The physician cut out about a 2 cm segment.When the physician cut the sling, all the tension that was felt with the sling was relieved.The urethra became certainly more mobile.The physician left the sling immediately under the urethra to hopefully reduce her pain, but yet still have some continence.The physician obtained hemostasis and closed the vaginal incision with a running #2-0 vicryl stitch.The patient tolerated the procedure well.There were no apparent complications.She was extubated and brought to the recovery room in good condition.
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