MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

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Model Number M0068318170

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Prolapse (2475); Dyspareunia (4505); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 02/27/2018

Event Type Injury

Event Description

Note: this manufacturer report pertains to the second of two devices implanted into the patient during the same procedure.It was reported to boston scientific corporation that an obtryx ii system - curved and an uphold lite with capio slim device were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unspecified injury.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the implantation.(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 received, a supplemental mdr will be filed.

Event Description

Manufacturer Narrative

Block h2: block a2, a3, b5, b7, h6 has been updated based on the additional information received on august 31, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of february 27, 2018, was chosen as a best estimate based on the date of the implantation.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6); (b)(6) hospital; (b)(6).Block h6: patient code e2330, e1309, e1310, e2006, e1404 capture the reported events of pain, urinary retention, urinary tract infection, erosion and dyspareunia.Impact code f2303 and f1901 capture the reported events of medication required and additional surgery.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 received, a supplemental mdr will be filed.

Manufacturer Narrative

Block h2: additional information.Blocks b5 (narrative) and h6 (patient code) has been updated based on the additional information received on november 4, 2022.Correction: block h6 (evaluation conclusion codes) has been corrected from cmc - appropriate term/code not available to cmc - conclusion not yet available.Block e2 (health professional?) has been corrected from yes to no.Block b3 date of event: the exact event onset date is unknown.The provided event date of february 27, 2018, was chosen as a best estimate based on the date of the implantation.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient code e2330, e1309, e1310, e1405, e0123 capture the reported events of pain, urinary retention, urinary tract infection, dyspareunia and nerve damage.Impact code f2303 and f1901 capture the reported events of medication required and additional surgery.

Event Description

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of the implantation.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain; e2311 - tenderness; e1705 - burning sensation; e2006 - vaginal mesh erosion at the vaginal wall; e1405 - dyspareunia; e1309 - incomplete bladder emptying; e1310 - urinary tract infection; e0123 - nerve damage; e2015 - atrophy; e020202 - depression.The following imdrf impact codes capture the reportable events of: f2303 - medication required; f1901 - additional surgery.

Event Description

Note: this manufacturer report pertains to the second of three devices implanted into the patient during the same procedure, uphold lite.Please refer to mfr report 3005099803-2022-01321, 3005099803-2022-01320, 3005099803-2022-05509 for the associated devices.It was reported to boston scientific corporation that an obtryx ii system - curved, uphold lite and graft materials - xenform device were implanted into the patient during a cystocele repair with uphold graft, bilateral sacrospinous ligament vaginal vault suspension, rectocele and enterocele repair with 6x10 xenform graft, transobturator tape sling placement, cystoscopy and perineoplasty procedure performed on (b)(6) 2018 for the treatment of pelvic organ prolapse, symptomatic rectocele and cystocele, stress urinary incontinence, uterovaginal prolapse, and large enterocele.Reportedly, the patient was taken to the recovery room in a normal, stable manner.The patient complains of vaginal pain at the introitus following the procedure.It's "crampy," she says.Because of the prolapse, she is unable to engage in sexual activity.She also claims that the pain has been present for over a year and that she does not have vaginal dryness.Furthermore, the patient visits the clinic on (b)(6) 2020, for a preoperative visit in preparation for her upcoming total laparoscopic hysterectomy and uterosacral vaginal vault suspension for uterovaginal prolapse.During her visit, a urinalysis was also performed, and the results confirmed that the patient had an acute lower urinary tract infection due to poor bladder emptying, vaginal atrophy, and uterine prolapse.To address symptomatic uterine prolapse and pelvic pain, the patient underwent a total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, bilateral uterosacral ligament vaginal suspension, and cystoscopy on (b)(6) 2020.The majority of the patient's prolapse, according to the surgeon, is due to cervical elongation, but it continues to bother her, and the possibility of performing a large loop excision of the transformation zone (lletz) procedure to remove the excess cervix was discussed at length.However, the patient desired a definitive treatment.Furthermore, the findings of the procedures performed are as follows: 1.The patient had bilateral atrophic ovaries.2.She had a very small atrophic uterus.3.She had a significant amount of uterine prolapse, in which the cervix prolapses approximately 1 cm outside the introitus while under anesthesia.4.There was an absence of the uterosacral ligaments bilaterally.5.She had a normal-appearing liver, and they were unable to visualize the gallbladder.6.There was good support of the anterior vaginal wall and urethra.7.The anterior polypropylene graft was identified during colpotomy.According to reports, the patient tolerated the procedures well and was taken to the recovery room in a sterile manner.On (b)(6) 2021, the patient comes in for a consultation with the chief complaint of pelvic pain in the context of prior pelvic reconstructive surgery.She describes burning vaginal pain that is relieved slightly by urinating.There is no bleeding or discharge.She has been suffering from this for several months, and it has gotten worse in the last five months.Her vaginal pain worsens with activity.It's important to note that she felt this way before her second surgery.Her urogynecologist discovered her vaginal mesh exposure during her most recent visit in (b)(6) 2021.She was given vaginal suppositories as well as oral estrogen.Tramadol has also been prescribed for her pain, which has been helpful.The patient notes a possible vaginal bulge inside the vagina.Additionally, she notes urgency and urge incontinence.She also mentions the sensation of an incomplete bladder emptying with a slow stream.During the consultation, the surgeon discussed with the patient his exam findings, which revealed that she had a mesh/suture exposure.It was near the anterior side of the apex and could be the uterosacral suspension's uphold mesh or permanent suture.She also has pain in the left arm of the transobturator sling, as well as an elevated pelvic vaginal repair, which could be due to sling obstruction.The surgeon discussed the possibility of an outpatient mesh and sling revision with removal of the exposed material at the apex and removal of the right sling arm.He advised her that removal of a portion of the sling may not necessarily cause a recurrence of her stress incontinence and that they would reassess her symptoms postoperatively.The patient was advised to start using vaginal estrogen cream three nights a week as this could improve her small apical exposure without the need for surgical revision.However, this may not alleviate her sling-related symptoms.Additionally, the patient will need urodynamic testing to further evaluate her voiding dysfunction.He advised her that removing a section of the sling would not necessarily result in a recurrence of her stress incontinence and that they would reevaluate her symptoms after surgery.The patient was advised to begin taking vaginal estrogen cream three nights per week in order to address her limited apical exposure without requiring surgical revision.This, however, may not relieve her sling-related discomfort.Urodynamic tests will also be required to further analyze the patient's voiding dysfunction.Boston scientific received an additional information on november 4, 2022 as follows: the patient seeks telemedicine advice after complaining of severe pain in her sit bone on (b)(6) 2022.She claimed that she experienced a burning sensation in the region, which became worse when she sat.Additionally, the patient experiences significant hesitancy and pain after urinating.She has also had nocturia three times.The patient claims she does not experience pain during bowel movements.She also claims that she avoided sexual activity due to severe pain.The patient, according to the doctor, had severe pudendal pain following her previous surgeries.Boston scientific received an additional information on january 24, 2023 as follows: on (b)(6) 2021, the patient had her second postoperative visit.During physical examination, it was found that the patient had an anterior vaginal mesh erosion.The patient presents on (b)(6) 2021, with symptoms of depression, anxiety, and headache.The patient was prescribed lithium and zoloft, according to the report, but she no longer takes them since they caused her side effects.She is, however, solely on gabapentin, which calms her down and helps with her depression but does not help with the headaches.She has a chin tremor that she believes is caused by lithium.She was also taking xanax from her psychiatrist, which was quite beneficial.She takes it on an as-needed basis, generally once a day.She suffers pelvic pain as a result of a bladder tack and some mesh that's not working.On (b)(6) 2021, the patient seeks telemedicine as a result of surgery on (b)(6) 2020.Since the procedure, the patient claims she has experienced horrible or burning pain with any activity, such as lifting in the pelvic or vaginal area.She rated pain a 7 out of 10.There was neither vaginal discharge nor spotting.The patient was informed that the mesh was slightly protruding and was given medicines and vaginal cream, both of which were ineffective.The patient can still urinate.She hasn't had sex since the procedure, though.On (b)(6) 2021, the patient returns the clinic with pelvic pain that she believes is caused by the mesh.According to the report, the patient is seeing her uro-gynecologist, but she needs pain relief in the meantime.Furthermore, the patient is taking 60 mg of ibuprofen, but it is not alleviating the pain.During her clinic visit, the following issues were on the patient's active concern list: patient active problem list during her clinic visit: benign essential tremor; major depressive disorder, recurrent episode.The patient presents to the clinic on (b)(6) 2021, with vaginal mesh exposure, recurring stage 2 anterior prolapse, incomplete bladder emptying, vaginal pain, urgency frequency, and urge incontinence.The patient was last seen on (b)(6) 2021, and was told to take estrogen cream and to return for urodynamic tests and a cystoscopy.She has been taking the estrogen cream on a regular basis since her last appointment.She is still experiencing vaginal and pelvic pain, particularly while ambulating.The physical exam findings are as follows: vagina: atrophic; persistent 5-mm area of mesh or suture exposure at the apex with surrounding granulation tissue; interval improvement in sacrospinous tenderness; bilateral sling arms prominent and tender to palpation without exposure (from left to right).Her exam is essentially the same as before, with the exception of some slight improvement in tissue tenderness.She still has an apical mesh or suture exposure, which causes her pain.The doctor suggested that the vaginal wall mesh be revised (apical and bilateral sling arms).

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Brand Name

UPHOLD LITE

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

FREUDENBERG MEDICAL MIS INC

2301 centennial boulevard

jeffersonville IN 47130

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

13787734

MDR Text Key

287910558

Report Number

3005099803-2022-01321

Device Sequence Number

Product Code

OTP

UDI-Device Identifier

08714729839200

UDI-Public

08714729839200

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K122459

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

03/16/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

01/16/2020

Device Model Number

M0068318170

Device Catalogue Number

831-817

Device Lot Number

0000053304

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

01/24/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

01/16/2017

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

64 YR

Patient Sex

Female

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

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