MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

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

Patient Problems Pulmonary Embolism (1498); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Loss of Vision (2139); Visual Disturbances (2140); Vomiting (2144); Brain Injury (2219); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Bowel Perforation (2668); Thrombosis/Thrombus (4440)

Event Date 10/01/2017

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2017, implant procedure date, as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting facility and physician is: (b)(6).(b)(4).

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.Please refer to mfr report 3005099803-2022-07429 for the associated device.It was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a procedure performed on (b)(6)2017 for the treatment of pelvic organ prolapse.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.Furthermore, complications arose after the patient was discharged.Within a few months, the patient began experiencing vaginal discharge and returned to the surgeon on many times over the next few months, but to no avail.On or around (b)(6) 2020, the patient began experiencing severe lower back pain, for which she received an x-ray in (b)(6) 2020.Her primary physician also suggested to undergo magnetic resonance imaging (mri).Furthermore, prior to her mri on (b)(6) 2021, the patient visited a chiropractor.The chiropractor manipulated the patient's back, and as a result, the patient started to have floaters in her left eye.On (b)(6) 2021, the patient went to see a doctor to have her eye inspected for probable permanent vision loss and was urged to go to the emergency room immediately.The patient's vision had worsened to the point where she did not feel comfortable driving, and her back pain limited her ability to walk, so her daughter drove her to the hospital that evening.After being examined, the patient was told to return later for further evaluation and was discharged.According to reports, the patient returned for several visits, but the physicians were unable to determine what was wrong with her eye.By this point, the patient had entirely lost vision in her left eye, and her back pain had spread to her hips and down her legs, preventing her from getting out of bed.The patient was admitted on (b)(6) 2021, and an mri revealed osteomyelitis.The patient underwent three spinal procedures to remove the infection and determine its origin after being moved to another facility.On (b)(6) 2021, the patient also underwent a spinal debridement procedure.During the procedure, an inferior vena cava was put in place to control the pulmonary embolism and several other clots throughout the patient's body.On (b)(6) 2021, the patient underwent her second spinal debridement surgery.On (b)(6) 2021, the patient underwent her third spinal surgery.During the procedure, rods and screws were inserted into the patient's back.Moreover, the doctor determined that the patient's mesh implant was the cause of the infection.While removing the implant, the doctor also discovered an additional bacterial infection, including in the patient's brain.Additionally, the patient underwent a bone graft during this procedure using hip bone to replace the spinal bone that was removed due to infection.Following this third surgery, the patient was treated for the infections with antibiotics injected directly into her eye by needle.On (b)(6) 2021, the patient began experiencing severe episodes of vomiting.An abdominal x-ray was performed, showing an ileus blockage which required an enema and was followed by uncontrollable defecation in bed.On (b)(6) 2021, the patient started experiencing severe disorientation and continued to vomit nonstop.Additionally, a perforation in the patient's bowel was found, and her condition started to deteriorate quickly.The patient had emergency abdominal cavity cleanout surgery later that day because of the bowel perforation.A ct scan was conducted after this emergency surgery, and physicians believed the patient had suffered brain damage during the procedure.The hospital then informed the patient's family to visit and say their final goodbyes to her.Later brain scans, though, revealed that the brain had recovered.On (b)(6) 2021, the patient had to undergo another procedure to repair the bowel perforation.On (b)(6) 2021, the patient underwent yet another surgery to clean out her abdomen.Reportedly, the multiple emergency surgeries to clean out the patient's bowel resulted in the placement of three drainage tubes, two colostomy bags, and an open wound requiring a wound vac.Furthermore, after around fifty (50) days in the hospital, the patient was discharged.The patient is living with one of her daughters as she continues physical therapy.She is unable to complete simple activities of daily living, including unassisted walking, and has complete vision loss in her left eye, which she is highly unlikely to regain.Additional information was received on january 12, 2023: it was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy, robotic assisted laparoscopic sacrocolpopexy, retropubic midurethral sling placement, posterior vaginal repair and cystoscopy procedure performed on (b)(6) 2017 for the treatment of pelvic organ prolapse and stress urinary incontinence with urethral hypermobility.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.The following were identified throughout the procedures: laparoscopic findings included bilaterally normal adnexa.Cystoscopy results include intact bladder mucosa with no cystotomy, sutures, mesh, lacerations, or lesions.Urine efflux from bilateral ureteral openings is normal.Normal urethra.Nevertheless, the patient tolerated the procedure well, was woken, and sent to the recovery room in stable condition.Additional information was received on march 10, 2023: on (b)(6) 2021, the patient presented with lumbosacral diskitis osteomyelitis with an epidural abscess and an intradural abscess extending to the thoracolumbar junction.Patient also had been found to have infection of her left eye, as well as cerebral abscesses.The patient has a mesh graft that was placed years ago.This extends to the front of the l5-s1 interspace and is likely the source of continued infection.Diagnostic imaging revealed patient is in status post-posterior surgery x2.She was advised that she would need to remove the mesh for source control.Given that surgery will extend to the anterior lumbosacral spine, the patient was advised that she should undergo lumbosacral fusion as this is her best opportunity for an anterior approach.The infection has cause significant osteomyelitis in addition to the diskitis and fusion is recommended.Moreover, the following procedures were performed: stage iii: part a: posterior thoracolumbar wound washout, insertion of posterior segmental instrumentation l4-s1, harvest of bilateral posterior iliac crest autograft, placement of bilateral iliac fixation, posterior arthrodesis l4-s1 with iliac crest autograft and bmp.Part b: harvest of structural left iliac crest autograft, l4-5 and l5-s1 diskectomies with complete 100% l5 corpectomy, anterior arthrodesis l4-s1 with structural iliac crest autograft.Additional procedures performed by other services: cardiology transesophageal echocardiogram, urology cystoscopy placement of bilateral ureteral catheters, gynecology removal of infected pelvic mesh.The surgeon performed a pelvic exploration and resection of the implanted mesh, which extended to the anterior sacrum, during the procedure.Once the mesh was removed, the surgeon performed anterior lumbosacral spine exposure.Due to significant scarring from the abscess, exposure was limited, and a retractor was utilized to aid in visualization.An additional exposure at l4-l5 and l5-s1 was required.Infection had destroyed the disc space at l5-s1, and further disc material had been removed.Infection had partially destroyed l5's vertebral body.A cobb elevator was used to remove the cartilaginous endplate from the bony endplate of l4 after an incision was made in the l4-5 interspace.The remaining l4-5 disc was removed and the remaining l5 vertebral body was removed with a curette and pituitary while operating underneath the iliac vessels.In addition, the previously implanted pedicle screw at the l5 tip was visible.The l5 nerve root and thecal sac were identified as well.According to reports, the infected bone at l5 was removed.Neuromonitoring has remained stable.A metal cutting bur was also used to trim the tip of the left l5 pedicle screw to aid in the placement of the bone graft.This was done without difficulty.Antibiotic irrigation was applied copiously to the wound.L4 and s1 endplates were prepared for fusion.The defect's size was measured in situ.The structural bone graft was cut to the correct height and width.The bone graft was placed between the l5-s1 and l4-5 interspaces.The bone graft was pressed into place.The graft was well seated and could be seen going at a slight oblique angle with excellent approximation to the endplates.A lateral x-ray confirmed the bone graft's proper placement.Throughout, the neuromonitoring remained stable.The patient was extubated, had baseline strength in both lower extremities, and was transported to the post anesthesia care unit (pacu).

Manufacturer Narrative

Block h2: additional information blocks b5 (narrative), d1 (brand name), d2b (pro code), d4 (model number, lot number, catalog number, expiration date and udi), g6b (explant date), d7a (sud reprocessed and reused) and g4 (premarket/510k) has been updated based on the additional information received on march 10, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2017, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting facility and surgeon is: dr.(b)(6).The explanting facility and surgeons are: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1006 - bowel perforation, e0102 - brain damage, e2328 - ileus blockage, e1906 - infections, e1901 - bacterial infection, e2330 - pain, e2326 - inflammation, e050303 - pulmonary embolism, e010701 - disorientation, e083902 - loss of vision, e1401 - abnormal vaginal discharge, e1715 - scarring, e172001 - abscess.The following imdrf impact codes capture the reportable event of: f18 - physical therapy, f1901 - emergency surgery, f2303 - antibiotic medication for infection, f1202 - unable to complete simple activities of daily living, f1203 - patient reported to have brain damage, f08 - patient had stayed in the hospital approximately 50 days, f21 - loss of vision.

Manufacturer Narrative

Block h2: additional information blocks a2 (date of birth) and b5 (narrative) has been updated based on the additional information received on january 12, 2023.Correction: block b3 (date of event) has been corrected based on the additional information received on january 12, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2017, implant procedure date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting facility and physician is: dr.(b)(6), (b)(6) hospital (b)(6), united states (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1006 - bowel perforation e0102 - brain damage e2328 - ileus blockage e1906 - infections e1901 - bacterial infection e2330 - pain e2326 - inflammation e050303 - pulmonary embolism e010701 - disorientation e083902 - loss of vision e1401 - abnormal vaginal discharge the following imdrf impact codes capture the reportable event of: f18 - physical therapy f1901 - emergency surgery f2303 - antibiotic medication for infection f1202 - unable to complete simple activities of daily living f1203 - patient reported to have brain damage f08 - patient had stayed in the hospital approximately 50 days f21 - loss of vision.

Event Description

Manufacturer Narrative

Block h2: correction block b5 (narrative) has been corrected.Block d7a (sud reprocessed and reused?) has been corrected.Block h6 (patient code - 9004: adhesions) has been added to capture the reported event of adhesions.Block b3 date of event: date of event was approximated to april 3, 2017, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting facility and surgeon is: (b)(6).The explanting facility and surgeons are: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1006 - bowel perforation e0102 - brain damage e2328 - ileus blockage e1906 - infections e1901 - bacterial infection e2330 - pain e2326 - inflammation e050303 - pulmonary embolism e010701 - disorientation e083902 - loss of vision e1401 - abnormal vaginal discharge e1715 - scarring e172001 - abscess e2101 - adhesions.The following imdrf impact codes capture the reportable event of: f18 - physical therapy f1901 - emergency surgery f2303 - antibiotic medication for infection f1202 - unable to complete simple activities of daily living f1203 - patient reported to have brain damage f08 - patient had stayed in the hospital approximately 50 days f21 - loss of vision.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2022-07429 for the associated device.It was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a procedure performed on (b)(6) 2017 for the treatment of pelvic organ prolapse.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.Furthermore, complications arose after the patient was discharged.Within a few months, the patient began experiencing vaginal discharge and returned to the surgeon on many times over the next few months, but to no avail.On or around (b)(6) 2020, the patient began experiencing severe lower back pain, for which she received an x-ray in (b)(6) 2020.Her primary physician also suggested to undergo magnetic resonance imaging (mri).Furthermore, prior to her mri on (b)(6) 2021, the patient visited a chiropractor.The chiropractor manipulated the patient's back, and as a result, the patient started to have floaters in her left eye.On (b)(6) 2021, the patient went to see a doctor to have her eye inspected for probable permanent vision loss and was urged to go to the emergency room immediately.The patient's vision had worsened to the point where she did not feel comfortable driving, and her back pain limited her ability to walk, so her daughter drove her to the hospital that evening.After being examined, the patient was told to return later for further evaluation and was discharged.According to reports, the patient returned for several visits, but the physicians were unable to determine what was wrong with her eye.By this point, the patient had entirely lost vision in her left eye, and her back pain had spread to her hips and down her legs, preventing her from getting out of bed.The patient was admitted on (b)(6) 2021, and an mri revealed osteomyelitis.The patient underwent three spinal procedures to remove the infection and determine its origin after being moved to another facility.On (b)(6) 2021, the patient also underwent a spinal debridement procedure.During the procedure, an inferior vena cava was put in place to control the pulmonary embolism and several other clots throughout the patient's body.On (b)(6) 2021, the patient underwent her second spinal debridement surgery.On (b)(6) 2021, the patient underwent her third spinal surgery.During the procedure, rods and screws were inserted into the patient's back.Moreover, the doctor determined that the patient's mesh implant was the cause of the infection.While removing the implant, the doctor also discovered an additional bacterial infection, including in the patient's brain.Additionally, the patient underwent a bone graft during this procedure using hip bone to replace the spinal bone that was removed due to infection.Following this third surgery, the patient was treated for the infections with antibiotics injected directly into her eye by needle.On (b)(6) 2021, the patient began experiencing severe episodes of vomiting.An abdominal x-ray was performed, showing an ileus blockage which required an enema and was followed by uncontrollable defecation in bed.On (b)(6) 2021, the patient started experiencing severe disorientation and continued to vomit nonstop.Additionally, a perforation in the patient's bowel was found, and her condition started to deteriorate quickly.The patient had emergency abdominal cavity cleanout surgery later that day because of the bowel perforation.A ct scan was conducted after this emergency surgery, and physicians believed the patient had suffered brain damage during the procedure.The hospital then informed the patient's family to visit and say their final goodbyes to her.Later brain scans, though, revealed that the brain had recovered.On (b)(6) 2021, the patient had to undergo another procedure to repair the bowel perforation.On (b)(6) 2021, the patient underwent yet another surgery to clean out her abdomen.Reportedly, the multiple emergency surgeries to clean out the patient's bowel resulted in the placement of three drainage tubes, two colostomy bags, and an open wound requiring a wound vac.Furthermore, after around fifty (50) days in the hospital, the patient was discharged.The patient is living with one of her daughters as she continues physical therapy.She is unable to complete simple activities of daily living, including unassisted walking, and has complete vision loss in her left eye, which she is highly unlikely to regain.Additional information was received on january 12, 2023: it was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy, robotic assisted laparoscopic sacrocolpopexy, retropubic midurethral sling placement, posterior vaginal repair and cystoscopy procedure performed on (b)(6) 2017 for the treatment of pelvic organ prolapse and stress urinary incontinence with urethral hypermobility.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.The following were identified throughout the procedures: laparoscopic findings included a bilaterally normal adnexa.Cystoscopy results include intact bladder mucosa with no cystotomy, sutures, mesh, lacerations, or lesions.Urine efflux from bilateral ureteral openings is normal.Normal urethra.Nevertheless, the patient tolerated the procedure well, was woken, and sent to the recovery room in stable condition.Additional information was received on march 10, 2023: on (b)(6) 2021, the patient presented with lumbosacral (l4-5 and l5-s1) diskitis osteomyelitis, lumbar epidural abscess, and thoracolumbar intradural abscess extending to the thoracolumbar junction.The patient also had been found to have an infection of her left eye, as well as cerebral abscesses.The patient has a mesh graft that was placed years ago.This extends to the front of the l5-s1 interspace and is likely the source of continued infection.The patient had previously undergone the following procedures in two stages: stage i- partial t12, complete l1, l2, l3, l4, and l5 laminectomy; l4-5 and l5-s1 left diskectomy and evacuation of diskitis; evacuation of epidural abscess l4-5 and l5-s1; intradural exploration and evacuation of the intradural abscess t12-l5; and microsurgical technique utilizing the operating room microscope; stage ii- posterior thoracolumbar wound washout; irrigation and debridement of l4-5 and l5-s1 interspace with continued pus tracking from the retroperitoneal space at l5-s1; intradural exploration left l4-5 to l5-s1 with evacuation of intradural abscess, release of arachnoid adhesions; and microsurgical technique utilizing the operating room microscope.She was advised that she would need to remove the mesh for source control.Given that surgery will extend to the anterior lumbosacral spine, the patient was advised that she should undergo lumbosacral fusion as this is her best opportunity for an anterior approach.The infection has cause significant osteomyelitis in addition to the diskitis and fusion is recommended.Moreover, the following procedures were performed: stage iii: part a: posterior thoracolumbar wound washout insertion of posterior segmental instrumentation l4-s1 harvest of bilateral posterior iliac crest autograft placement of bilateral iliac fixation posterior arthrodesis l4-s1 with iliac crest autograft and bmp part b: harvest of structural left iliac crest autograft l4-5 and l5-s1 diskectomies with complete 100% l5 corpectomy, anterior arthrodesis l4-s1 with structural iliac crest autograft additional procedures performed by other services: cardiology transesophageal echocardiogram urology cystoscopy placement of bilateral ureteral catheters gynecology removal of infected pelvic mesh the surgeon performed a pelvic exploration and resection of the implanted mesh, which extended to the anterior sacrum, during the procedure.Once the mesh was removed, the surgeon performed anterior lumbosacral spine exposure.Due to significant scarring from the abscess, exposure was limited, and a retractor was utilized to aid in visualization.An additional exposure at l4-l5 and l5-s1 was required.Infection had destroyed the disc space at l5-s1, and further disc material had been removed.Infection had partially destroyed l5's vertebral body.A cobb elevator was used to remove the cartilaginous endplate from the bony endplate of l4 after an incision was made in the l4-5 interspace.The remaining l4-5 disc was removed and the remaining l5 vertebral body was removed with a curette and pituitary while operating underneath the iliac vessels.In addition, the previously implanted pedicle screw at the l5 tip was visible.The l5 nerve root and thecal sac were identified as well.According to reports, the infected bone at l5 was removed.Neuromonitoring has remained stable.A metal cutting bur was also used to trim the tip of the left l5 pedicle screw to aid in the placement of the bone graft.This was done without difficulty.Antibiotic irrigation was applied copiously to the wound.L4 and s1 endplates were prepared for fusion.The defect's size was measured in situ.The structural bone graft was cut to the correct height and width.The bone graft was placed between the l5-s1 and l4-5 interspaces.The bone graft was pressed into place.The graft was well seated and could be seen going at a slightly oblique angle with excellent approximation to the endplates.A lateral x-ray confirmed the bone graft's proper placement.Throughout, the neuromonitoring remained stable.The patient was extubated, had baseline strength in both lower extremities, and was transported to the post anesthesia care unit (pacu).Additional information was received on january 31, 2024: on (b)(6) 2021, the patient presented at the clinic with a six-week history of back pain.Upon examination, she was diagnosed with osteomyelitis of the l4-s1 vertebrae, an epidural abscess, and a brain abscess.Notably, a sagittal view on computed tomography (ct) of the abdomen/pelvis revealed an inflammatory tract extending from l5-s1 down to the cervical stump, precisely following the path of the sacrocolpopexy mesh.Given the presence of purulent discharge and the confirmed osteomyelitis at the l5/s1 level, it is suspected that the mesh may be the source of the patient's infection.Consequently, the patient was advised to undergo a follow-up vaginal culture and to continue antibiotic treatment over the weekend.Furthermore, if the patient does not show clinical improvement by (b)(6) 2021, a reevaluation will be conducted to consider the possibility of mesh removal surgery.On (b)(6) 2021, the patient sought a consultation for further evaluation of osteomyelitis and fluid collection related to an epidural abscess.The patient had been experiencing lower back pain for the past six weeks.During this time, there were no fevers, chills, new onset weakness, or bowel/bladder dysfunction reported.The patient underwent an irrigation and debridement procedure for the epidural abscess at the t12-l5 level on (b)(6) 2021, performed by the neurosurgery team.Following this, the patient developed left foot weakness, prompting a washout procedure at the l5-s1 level on (b)(6) 2021, due to concerns about residual fluid infection.During the same hospital admission, the patient was diagnosed with vitreous hemorrhage, which was subsequently evaluated by ophthalmology.Additionally, a ct imaging revealed an acute thrombosis within the inferior vena cava (ivc) and bilateral common iliac veins.As a result, an ivc filter was placed.Further management included a blood culture, which tested positive for streptococcus intermedius.A neurosurgery was planned for a potential surgical intervention involving additional spinal procedures and the possible removal of mesh (likely related to the epidural abscess) in collaboration with gynecology.Plastic surgeons were also consulted to evaluate the possibility of spinal wound closure.The patient's medical history includes feculent peritonitis, which was secondary to sigmoid perforation.The following interventions were performed: (b)(6) 2021: a washout procedure was carried out.(b)(6) 2021: the patient underwent a sigmoidectomy along with another washout.(b)(6) 2021: a comprehensive procedure involving washout, end colostomy, and abdominal wall debridement was performed.Additionally, the patient had complications related to a pseudomonas infection, which led to an abscess.The following interventions were undertaken: (b)(6) 2021: an interventional radiology drain was inserted.(b)(6) 2021: the drain was upsized.(b)(6) 2021: the patient experienced feculent drainage from the rectal stump, necessitating an additional drain.(b)(6) 2021: a large pelvic collection sip drain was removed.To manage the situation, the patient has been on suppressive amoxicillin due to the presence of spinal hardware.On (b)(6) 2021, a patient came in with two new abdominal abscesses.This patient had a complex medical history going back several years.Around (b)(6) 2017, she started experiencing persistent vaginal discharge, but she didn't seek medical attention until (b)(6) 2020, when she developed low back pain and severe fatigue.An mri revealed lumbar spinal diskitis osteomyelitis and multiple abscesses in her spine, abdomen, and pelvis.These abscesses were caused by vaginal mesh infections and disintegration.She underwent several surgeries, including spinal debridement/reconstruction, removal of the infected mesh, and treatment for bowel perforation.She also had a deep vein thrombosis in her leg, which required an ivc filter.The patient experienced abdominal pain for six weeks, especially during exercise.She took amoxicillin for infection prevention related to her spinal hardware.She also noticed redness and induration on her lower abdomen.A ct venogram confirmed the presence of new abscesses.On (b)(6) 2022, the patient experienced a sudden foot drop on the left side, which she attributed to a deep vein thrombosis (dvt) in her lower left extremity.She also reported pain across her lower back and down her tight lower extremities.As a result, the patient faces significant functional limitations: standing and ambulation: the patient cannot stand or walk for extended periods.She can only stand for approximately 10 to 15 minutes at a time and relies on a railing for negotiating steps.Lifting and carrying: the patient is unable to lift groceries and laundry, especially when carrying them upstairs.Driving: due to her condition, the patient is unable to drive.In addition to the foot drop and dvt, the patient presents with myofascial restrictions, hypertrophy of the paraspinal, and mild to moderate strength deficits throughout her left lower extremities.To address these challenges, the patient requires skilled therapy aimed at restoring her prior level of function.The patient actively participated in creating the current goals after extensive education regarding diagnosis, prognosis, and treatment options.On (b)(6) 2023, the patient went for a follow up consultation due to metastatic endophthalmitis left eye (os) secondary to an infected bladder mesh support.The patient's initial examination on (b)(6) 2021 revealed vision acuity of 20/25+100 in the right eye and hand motion (hm) in the left eye (os).She had panuveitis os with a large white retinal lesion temporally.B-scan imaging showed vitritis, an incomplete posterior vitreous opacity (pvo), and an elevated retinal lesion in the inferotemporal periphery with mixed hyperlucencies.The combination of leukocytosis, normocytic anemia, thrombocytosis, elevated alkaline phosphatase, and transaminemia raised the possibility of a leukemic process.Lymphoma was less likely, and primary vitreoretinal lymphoma was extremely unlikely due to the lesion's size and location.Toxoplasmosis was a possibility, but the lesion was unusually large.Sarcoidosis was also unlikely.The patient needed urgent evaluation by a hematologist.An anterior chamber tap was performed without complications, and the sample was sent for ocular virus toxo pcr.She started prednisolone acetate 1% eye drops 8 times a day and cyclopentolate 2% eye drops twice a day os.She was referred in ocular oncology.Pcr from the aqueous humor on (b)(6) 2021 was negative for hsv-1/2, vzv, cmv, and toxoplasma gondii.The patient later developed difficulty walking and severe leg pain, leading to admission to on (b)(6) 2021.The workup revealed a pulmonary embolism (pe), multiple emboli, brain lesions, and spinal infection caused by three different bacteria.The primary source was suspected to be infected mesh from a prior bladder suspension procedure.Moreover, the patient underwent a cardiac echo, which ruled out endocarditis.A basket was also placed in the inferior vena cava (ivc) to reduce the risk of further pulmonary emboli.The patient's daughter was informed that she would be seen back in the retina service once she could leave the hospital.On (b)(6) 2021, the patient reported mild aching in the left eye, which was improving.She was eventually discharged from the hospital in (b)(6) 2021.Although her abdominal drain was removed, she still had an ostomy and required a wheelchair.Her central nervous system (cns) abscess had cleared.During an exam on (b)(6) 2021, the right eye remained asymptomatic, but the left eye had occasional periorbital aching and chronic redness.The exam showed visual acuity of 20/25-200 and light perception (lp) in the left eye, with an intraocular pressure (iop) of 1000 and 12 mmhg.B-scan imaging revealed a funnel retinal detachment in the left eye, and surgery was deferred due to poor visual prognosis and overall health.The persistent anterior uveitis was attributed to the chronic retinal detachment (schwartz-matsuo syndrome).She had dense nuclear sclerosis cataracts in the left eye and mild nuclear sclerosis in the right eye.Treatment included atropine 1% eye drops twice a day and prednisolone acetate 1% eye drops every other day.On (b)(6) 2021 she had no symptoms, and the left eye was pain-free.Her general health included a bout of gastroenteritis in late (b)(6) 2021, which required a 2-day hospital stay for hydration.Serial ct scans remained stable, and no new antibiotic therapy or drainage was recommended; she continued amoxicillin (likely through (b)(6) 2021).Additionally, the patient was in physical therapy (pt) three times a week, and her lower extremity weakness was gradually improving.She still required braces and a rolling walker.Her exam on (b)(6) 2021 showed visual acuity (va) of 20/25 with no significant neurological issues (phni) in the right eye.The left eye had light perception (lp) with intraocular pressure (iop) of 15 mmhg and 2+ cells.The panuveitis was inactive in the left eye (os).There was a non-operable retinal detachment (ro) in the left eye (os).She tapered prednisolone acetate 1% eye drops to twice a day (bid) os and atropine 1% eye drops to once a day (q day) os.When seen on (b)(6) 2021, the right eye remained asymptomatic.The blind left eye had no pain.She was being considered for take-down of the colostomy and then the ileostomy 6 weeks later.She was able to ambulate using a cane.Her exam on (b)(6) 2021 showed va of 20/30-1 with no significant neurological issues (phni) in the left eye (os).The panuveitis was inactive in the left eye (os).There was a non-operable retinal detachment (ro) in the left eye (os).There was a white cataract and total retinal detachment (ro) in the left eye (os) for which surgery was not indicated.She tapered prednisolone acetate 1% eye drops to twice a day (bid) os and atropine 1% eye drops to once a day (q day) os.When seen on (b)(6) 2022, the right eye was asymptomatic.The left eye had no pain.Her general health was good.Her exam on (b)(6) 2022 showed va of 20/25-300 and no light perception (nlp) in the left eye (os).The right eye showed some small vitreous floaters and 1-2+ nuclear sclerosis cataract with cup-to-disc ratio (c: 0.3), no cystoid macular edema (cme), and stable chorioretinal scarring at 5:00.The left eye had vortex corneal epitheliopathy, absent anterior chamber cells, dense pseudophakic scarring, and brunescent cataract.There was no view of the fundus in the left eye (os).Optical coherence tomography (oct) showed no cme and central subfield thickness (cst) of 243 microns (00).No surgical intervention was indicated for the total retinal detachment (rd) in the left eye (os).She continued atropine 1% eye drops once a day (q day) os and prednisolone acetate 1% eye drops twice a day (bid) os.A 6-month follow-up was planned.She had take-down of her colostomy on (b)(6) 2022 and then closure of the ileostomy in (b)(6) 2022.Her exam on (b)(6) 2022 showed va of 20/40+3 with no significant neurological issues (phni) in the left eye (os).The panuveitis was suppressed in the left eye (os).She continued prednisolone acetate 1% eye drops twice a day (bid) os and atropine 1% eye drops once a day (q day) os for comfort.The patient had mild nuclear sclerosis cataract and no cystoid macular edema (cme) in the right eye.A 6-month follow-up was planned.When seen on (b)(6) 2023, she was doing well with new progressive lenses from (b)(6) 2023 (after the initial prescription was changed).She had no pain, floaters, or photopsias.The left eye had no pain.Her general health was good.She was off eliquis, and her inferior vena cava (ivc) filter was removed.Review of systems (ros): negative for recent constitutional, ent, pulmonary, cardiac, gi, gu, hematologic, neurologic, rheumatologic, endocrine, allergic, or psychiatric issues.No known drug allergies (nkda).

Manufacturer Narrative

Block h2: correction: block b5 has been updated.Block b3 date of event: date of event was approximated to (b)(6) 2017, the date when the patient started experiencing symptoms.Block e1: this event was reported by the patient's legal representation.The implanting facility and surgeon are: dr.(b)(6).(b)(6) hospital.(b)(6).The explanting facility and surgeons are: dr.(b)(6).Dr.(b)(6).(b)(6) health (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1006 - bowel perforation, e0102 - brain damage, e2328 - ileus blockage, e1906 - infections, e1901 - bacterial infection, e2330 - pain, e2326 - inflammation, e050303 - pulmonary embolism, e010701 - disorientation, e083902 - loss of vision, e1401 - abnormal vaginal discharge, e1715 - scarring, e172001 - abscess, e2101 - adhesions, e1621 - muscle weakness, e0123 - nerve damage, e231501 - purulent discharge, e0514 - deep vein thrombosis.The following imdrf impact codes capture the reportable event of: f18 - physical therapy, f1901 - emergency surgery, f2303 - antibiotic medication for infection, f1202 - unable to complete simple activities of daily living, f1203 - patient reported to have brain damage, f08 - patient had stayed in the hospital approximately 50 days, f21 - loss of vision.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2022-07429 for the associated device.It was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a procedure performed on (b)(6) 2017 for the treatment of pelvic organ prolapse.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.Furthermore, complications arose after the patient was discharged.Within a few months, the patient began experiencing vaginal discharge and returned to the surgeon on many times over the next few months, but to no avail.On or around (b)(6) 2020, the patient began experiencing severe lower back pain, for which she received an x-ray in (b)(6) 2020.Her primary physician also suggested to undergo magnetic resonance imaging (mri).Furthermore, prior to her mri on (b)(6) 2021, the patient visited a chiropractor.The chiropractor manipulated the patient's back, and as a result, the patient started to have floaters in her left eye.On (b)(6) 2021, the patient went to see a doctor to have her eye inspected for probable permanent vision loss and was urged to go to the emergency room immediately.The patient's vision had worsened to the point where she did not feel comfortable driving, and her back pain limited her ability to walk, so her daughter drove her to the hospital that evening.After being examined, the patient was told to return later for further evaluation and was discharged.According to reports, the patient returned for several visits, but the physicians were unable to determine what was wrong with her eye.By this point, the patient had entirely lost vision in her left eye, and her back pain had spread to her hips and down her legs, preventing her from getting out of bed.The patient was admitted on (b)(6) 2021, and an mri revealed osteomyelitis.The patient underwent three spinal procedures to remove the infection and determine its origin after being moved to another facility.On (b)(6) 2021, the patient also underwent a spinal debridement procedure.During the procedure, an inferior vena cava was put in place to control the pulmonary embolism and several other clots throughout the patient's body.On (b)(6) 2021, the patient underwent her second spinal debridement surgery.On (b)(6) 2021, the patient underwent her third spinal surgery.During the procedure, rods and screws were inserted into the patient's back.Moreover, the doctor determined that the patient's mesh implant was the cause of the infection.While removing the implant, the doctor also discovered an additional bacterial infection, including in the patient's brain.Additionally, the patient underwent a bone graft during this procedure using hip bone to replace the spinal bone that was removed due to infection.Following this third surgery, the patient was treated for the infections with antibiotics injected directly into her eye by needle.On (b)(6) 2021, the patient began experiencing severe episodes of vomiting.An abdominal x-ray was performed, showing an ileus blockage which required an enema and was followed by uncontrollable defecation in bed.On (b)(6) 2021, the patient started experiencing severe disorientation and continued to vomit nonstop.Additionally, a perforation in the patient's bowel was found, and her condition started to deteriorate quickly.The patient had emergency abdominal cavity cleanout surgery later that day because of the bowel perforation.A ct scan was conducted after this emergency surgery, and physicians believed the patient had suffered brain damage during the procedure.The hospital then informed the patient's family to visit and say their final goodbyes to her.Later brain scans, though, revealed that the brain had recovered.On (b)(6) 2021, the patient had to undergo another procedure to repair the bowel perforation.On (b)(6) 2021, the patient underwent yet another surgery to clean out her abdomen.Reportedly, the multiple emergency surgeries to clean out the patient's bowel resulted in the placement of three drainage tubes, two colostomy bags, and an open wound requiring a wound vac.Furthermore, after around fifty (50) days in the hospital, the patient was discharged.The patient is living with one of her daughters as she continues physical therapy.She is unable to complete simple activities of daily living, including unassisted walking, and has complete vision loss in her left eye, which she is highly unlikely to regain.***additional information was received on january 12, 2023*** it was reported to boston scientific corporation that an advantage fit system and upsylon y-mesh, was implanted into the patient during a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy, robotic assisted laparoscopic sacrocolpopexy, retropubic midurethral sling placement, posterior vaginal repair and cystoscopy procedure performed on (b)(6) 2017 for the treatment of pelvic organ prolapse and stress urinary incontinence with urethral hypermobility.According to reports, the patient had no knowledge of having stress urinary incontinence at the time; however, the physician recommended that she have a sling placed to prevent stress urinary incontinence that may develop after her pelvic organ prolapse repair.The following were identified throughout the procedures: laparoscopic findings included a bilaterally normal adnexa.Cystoscopy results include intact bladder mucosa with no cystotomy, sutures, mesh, lacerations, or lesions.Urine efflux from bilateral ureteral openings is normal.Normal urethra.Nevertheless, the patient tolerated the procedure well, was woken, and sent to the recovery room in stable condition.***additional information was received on march 10, 2023*** on (b)(6) 2021, the patient presented with lumbosacral (l4-5 and l5-s1) diskitis osteomyelitis, lumbar epidural abscess, and thoracolumbar intradural abscess extending to the thoracolumbar junction.The patient also had been found to have an infection of her left eye, as well as cerebral abscesses.The patient has a mesh graft that was placed years ago.This extends to the front of the l5-s1 interspace and is likely the source of continued infection.The patient had previously undergone the following procedures in two stages: stage i- partial t12, complete l1, l2, l3, l4, and l5 laminectomy; l4-5 and l5-s1 left diskectomy and evacuation of diskitis; evacuation of epidural abscess l4-5 and l5-s1; intradural exploration and evacuation of the intradural abscess t12-l5; and microsurgical technique utilizing the operating room microscope; stage ii- posterior thoracolumbar wound washout; irrigation and debridement of l4-5 and l5-s1 interspace with continued pus tracking from the retroperitoneal space at l5-s1; intradural exploration left l4-5 to l5-s1 with evacuation of intradural abscess, release of arachnoid adhesions; and microsurgical technique utilizing the operating room microscope.She was advised that she would need to remove the mesh for source control.Given that surgery will extend to the anterior lumbosacral spine, the patient was advised that she should undergo lumbosacral fusion as this is her best opportunity for an anterior approach.The infection has cause significant osteomyelitis in addition to the diskitis and fusion is recommended.Moreover, the following procedures were performed: stage iii: part a: posterior thoracolumbar wound washout, insertion of posterior segmental instrumentation l4-s1, harvest of bilateral posterior iliac crest autograft, placement of bilateral iliac fixation, posterior arthrodesis l4-s1 with iliac crest autograft and bmp.Part b: harvest of structural left iliac crest autograft, l4-5 and l5-s1 diskectomies with complete 100% l5 corpectomy, anterior arthrodesis l4-s1 with structural iliac crest autograft.Additional procedures performed by other services: cardiology transesophageal echocardiogram, urology cystoscopy placement of bilateral ureteral catheters, gynecology removal of infected pelvic mesh.The surgeon performed a pelvic exploration and resection of the implanted mesh, which extended to the anterior sacrum, during the procedure.Once the mesh was removed, the surgeon performed anterior lumbosacral spine exposure.Due to significant scarring from the abscess, exposure was limited, and a retractor was utilized to aid in visualization.An additional exposure at l4-l5 and l5-s1 was required.Infection had destroyed the disc space at l5-s1, and further disc material had been removed.Infection had partially destroyed l5's vertebral body.A cobb elevator was used to remove the cartilaginous endplate from the bony endplate of l4 after an incision was made in the l4-5 interspace.The remaining l4-5 disc was removed and the remaining l5 vertebral body was removed with a curette and pituitary while operating underneath the iliac vessels.In addition, the previously implanted pedicle screw at the l5 tip was visible.The l5 nerve root and thecal sac were identified as well.According to reports, the infected bone at l5 was removed.Neuromonitoring has remained stable.A metal cutting bur was also used to trim the tip of the left l5 pedicle screw to aid in the placement of the bone graft.This was done without difficulty.Antibiotic irrigation was applied copiously to the wound.L4 and s1 endplates were prepared for fusion.The defect's size was measured in situ.The structural bone graft was cut to the correct height and width.The bone graft was placed between the l5-s1 and l4-5 interspaces.The bone graft was pressed into place.The graft was well seated and could be seen going at a slightly oblique angle with excellent approximation to the endplates.A lateral x-ray confirmed the bone graft's proper placement.Throughout, the neuromonitoring remained stable.The patient was extubated, had baseline strength in both lower extremities, and was transported to the post anesthesia care unit (pacu).***additional information was received on january 31, 2024*** on (b)(6) 2021, the patient presented at the clinic with a six-week history of back pain.Upon examination, she was diagnosed with osteomyelitis of the l4-s1 vertebrae, an epidural abscess, and a brain abscess.Notably, a sagittal view on computed tomography (ct) of the abdomen/pelvis revealed an inflammatory tract extending from l5-s1 down to the cervical stump, precisely following the path of the sacrocolpopexy mesh.Given the presence of purulent discharge and the confirmed osteomyelitis at the l5/s1 level, it is suspected that the mesh may be the source of the patient's infection.Consequently, the patient was advised to undergo a follow-up vaginal culture and to continue antibiotic treatment over the weekend.Furthermore, if the patient does not show clinical improvement by (b)(6) 2021, a reevaluation will be conducted to consider the possibility of mesh removal surgery on (b)(6) 2021, the patient sought a consultation for further evaluation of osteomyelitis and fluid collection related to an epidural abscess.The patient had been experiencing lower back pain for the past six weeks.During this time, there were no fevers, chills, new onset weakness, or bowel/bladder dysfunction reported.The patient underwent an irrigation and debridement procedure for the epidural abscess at the t12-l5 level on (b)(6) 2021, performed by the neurosurgery team.Following this, the patient developed left foot weakness, prompting a washout procedure at the l5-s1 level on (b)(6) 2021, due to concerns about residual fluid infection.During the same hospital admission, the patient was diagnosed with vitreous hemorrhage, which was subsequently evaluated by ophthalmology.Additionally, a ct imaging revealed an acute thrombosis within the inferior vena cava (ivc) and bilateral common iliac veins.As a result, an ivc filter was placed.Further management included a blood culture, which tested positive for streptococcus intermedius.A neurosurgery was planned for a potential surgical intervention involving additional spinal procedures and the possible removal of mesh (likely related to the epidural abscess) in collaboration with gynecology.Plastic surgeons were also consulted to evaluate the possibility of spinal wound closure.The patient's medical history includes feculent peritonitis, which was secondary to sigmoid perforation.The following interventions were performed: (b)(6) 2021: a washout procedure was carried out.(b)(6) 2021: the patient underwent a sigmoidectomy along with another washout.(b)(6) 2021: a comprehensive procedure involving washout, end colostomy, and abdominal wall debridement was performed.Additionally, the patient had complications related to a pseudomonas infection, which led to an abscess.The following interventions were undertaken: (b)(6) 2021: an interventional radiology drain was inserted.(b)(6) 2021: the drain was upsized.(b)(6) 2021: the patient experienced feculent drainage from the rectal stump, necessitating an additional drain.(b)(6) 2021: a large pelvic collection sip drain was removed.To manage the situation, the patient has been on suppressive amoxicillin due to the presence of spinal hardware.On (b)(6) 2021, a patient came in with two new abdominal abscesses.This patient had a complex medical history going back several years.Around (b)(6) 2017, she started experiencing persistent vaginal discharge, but she didn't seek medical attention until (b)(6) 2020, when she developed low back pain and severe fatigue.An mri revealed lumbar spinal diskitis osteomyelitis and multiple abscesses in her spine, abdomen, and pelvis.These abscesses were caused by vaginal mesh infections and disintegration.She underwent several surgeries, including spinal debridement/reconstruction, removal of the infected mesh, and treatment for bowel perforation.She also had a deep vein thrombosis in her leg, which required an ivc filter.The patient experienced abdominal pain for six weeks, especially during exercise.She took amoxicillin for infection prevention related to her spinal hardware.She also noticed redness and induration on her lower abdomen.A ct venogram confirmed the presence of new abscesses.On (b)(6) 2022, the patient experienced a sudden foot drop on the left side, which she attributed to a deep vein thrombosis (dvt) in her lower left extremity.She also reported pain across her lower back and down her tight lower extremities.As a result, the patient faces significant functional limitations: standing and ambulation: the patient cannot stand or walk for extended periods.She can only stand for approximately 10 to 15 minutes at a time and relies on a railing for negotiating steps.Lifting and carrying: the patient is unable to lift groceries and laundry, especially when carrying them upstairs.Driving: due to her condition, the patient is unable to drive.In addition to the foot drop and dvt, the patient presents with myofascial restrictions, hypertrophy of the paraspinal, and mild to moderate strength deficits throughout her left lower extremities.To address these challenges, the patient requires skilled therapy aimed at restoring her prior level of function.The patient actively participated in creating the current goals after extensive education regarding diagnosis, prognosis, and treatment options.

Manufacturer Narrative

Block h2: additional information.Blocks b5 (narrative), b7 (other relevant history), h6 (patient codes) has been updated based on the additional information received on january 31, 2024.Correction: block b3 (event date) has been corrected based on the additional information received.Block b3 date of event: date of event was approximated to (b)(6) 2017, the date when the patient started experiencing symptoms.Block e1: this event was reported by the patient's legal representation.The implanting facility and surgeon is: (b)(6).The explanting facility and surgeons are: (b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e1006 - bowel perforation, e0102 - brain damage, e2328 - ileus blockage, e1906 - infections, e1901 - bacterial infection, e2330 - pain, e2326 - inflammation, e050303 - pulmonary embolism, e010701 - disorientation, e083902 - loss of vision, e1401 - abnormal vaginal discharge, e1715 - scarring, e172001 - abscess, e2101 - adhesions, e1621 - muscle weakness, e0123 - nerve damage, e231501 - purulent discharge, e0514 - deep vein thrombosis.The following imdrf impact codes capture the reportable event of: f18 - physical therapy, f1901 - emergency surgery, f2303 - antibiotic medication for infection, f1202 - unable to complete simple activities of daily living, f1203 - patient reported to have brain damage, f08 - patient had stayed in the hospital approximately 50 days, f21 - loss of vision.

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Brand Name

UPSYLON

Type of Device

MESH, SURGICAL, SYNTHETIC

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

PROXY BIOMEDICAL LIMITED

coilleach spiddal

galway

Manufacturer Contact

farshad fahimi

4100 hamline avenue north

building c

saint paul, MN 55112

5086834015

MDR Report Key

16034219

MDR Text Key

305995514

Report Number

3005099803-2022-07427

Device Sequence Number

Product Code

OTO

UDI-Device Identifier

08714729839217

UDI-Public

08714729839217

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K122794

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

12/22/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

11/30/2019

Device Model Number

M0068318200

Device Catalogue Number

831-820

Device Lot Number

C003168

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

03/04/2024

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

11/23/2016

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Disability; Life Threatening; Hospitalization;

Patient Age

61 YR

Patient Sex

Female

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

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