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

BOSTON SCIENTIFIC CORPORATION PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

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Model Number M0068317170

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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); Urinary Frequency (2275); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 08/05/2019

Event Type Injury

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device was implanted and 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.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that solyx sis system and pfr kit uphold lite vaginal support system devices were implanted into the patient during an anterior colprrhapy with mesh, tvt-o urethral suspension and cystoscopy procedure performed on (b)(6)2013 for the treatment of stress urinary incontinence, cystocele and severe vaginal atrophy.Operative findings included extremely atrophic vaginal tissues and huge varicosities in the perivesical and periurethral space.A piece of light blue uphold mesh was placed and sutured on 4 comers in the anterior space.Dissection into the perivesical space was extremely perilous due to the large varicosities.Therefore, decision was made to stick with a local piece of mesh, rather than attempt to attach it to the sacrospinous ligaments bilaterally.After the procedure, the patient is continuing to have incontinence.The testing did reveal a low urethral opening pressure.On (b)(6) 2014, the patient underwent a detachment and removal of solyx mesh and tvt-o urethral suspension to treat recurring urinary incontinence, cystocele and severe vaginal atrophy.The patient had a complete detachment on the left side of the solyx mesh.Both sides were detached and barb ends were removed without difficulty.A non-bsc transobturator suburethral mesh was placed and pulled up to proper tension and cut off at proper length.Reportedly, there was approximately 100cc of blood loss observed.Good hemostasis and good approximation was noted during the procedure.The patient tolerated the procedure well and sent to recovery room in good condition.On (b)(6) 2019, the patient went to the hospital with the complaints of dysuria, urinary urgency, urinary frequency, and lower abdominal pain.The assessment was acute cystitis with hematuria.The patient was given an antibiotic to treat the symptoms and was advised to have a follow-up check up if the symptoms are not resolved.On (b)(6) 2019, the patient went to the hospital with the complaints of vaginal discharge, odor, color.The assessment was bacterial vaginosis.The patient was prescribed metrogel and advised to follow up with her gynecologist regarding her recurrent bacterial vaginosis.On (b)(6) 2020, the patient went to the hospital with a complaint of fatigue.The patient mentioned that she has been feeling significantly fatigued, lightheaded and dizzy on occasion.She also had a headache that was relieved by ibuprofen.On (b)(6) 2020, the patient went to the hospital with a complaint of flank pain.The patient also mentioned that she also had experienced some pressure with urination that is not relieved after urinating, urinary urgency, frequency, dark yellow colored urine, chills, and fatigue.Assessments revealed that the patient had a pyelonephritis.Subsequently, an antibiotic was prescribed to the patient to treat the symptoms.On (b)(6) 2020, the patient went to the hospital with the complaints of abdominal pain and continued dysuria.The patient added that she had maybe passed a stone on the same day.Reportedly, she had some sort of stone issue, meaning renal colic in 2018.Exam revealed central abdominal and suprapubic tenderness.Urinalysis showed no evidence of blood or infection.Abdominal and pelvis ct showed no significant pathology, no evidence of renal stone, pyelonephritis or bowel obstruction.The patient was treated with pain medication, anti-nausea medication, and an antibiotic for the abdominal pain likely from her resolving pyelonephritis.On (b)(6) 2020, the patient presents to the clinic with complaints of vaginal discomfort.The symptoms started a week ago with development of vaginal itching and external vaginal redness and discomfort.Subsequently, an antifungal medication was prescribed to the patient to treat yeast vaginitis.(b)(6) 2020, the patient presents to the clinic with complaint of abdominal pain.Patient stated that she is having a lot of difficulty eating because she ends up having abdominal pain every time she eats.The patient had also experienced vaginal dryness, fatigue, mass of left breast, migraine, post-hysterectomy menopause, and prurigo nodularis.On (b)(6) 2020, the patient had experienced an increasing abdominal discomfort.The patient reported that she had an abdominal pain if she eats any kind of food more or less right away.She also had experienced a diarrhea alternating constipation on the same day.The patient indicates this is all been progressive since she had a cholecystectomy in early (b)(6) 2020.A ct scan was done of the patient's abdomen and pelvis with iv contrast.It shows no pathology of the delivery triage, no evidence of pancreatic inflammation.No evidence of bowel obstruction or free fluid.An intravenous medication of haldol 5mg and 1000mg of tylenol was given to the patient an smear the abdominal wall with capsaicin 0.1% cream.On (b)(6) 2021, the patient presents to the clinic with severe pelvic/vaginal pain.The patient also mentioned that the pain is unbearable when moving and during sexual intercourse.Reportedly, the patient is currently undergoing a pelvic floor therapy and also taking bladder antispasmodic agent prescribed by a physician.She had previously seen a urogynecologist on (b)(6) 2021 where a cystoscopy was unremarkable, and the physician thought the patient had pelvic floor muscle spasms.On (b)(6) 2021, ct of the abdomen and pelvis were unremarkable.On (b)(6) 2021 mri of the pelvis showed changes suggestive of right hip impingement otherwise unremarkable and nothing seen to account for the left-sided pelvic pain.Exam revealed introitus and perineum without pain, mild pain discomfort with deep palpation of the posterior vagina, moderate pain of anterior vagina over which lays the bladder, and severe pain with superior 1/3 of left lateral aspect of vagina.No significant rectocele or cystocele and no leaking of urine noted.The assessment was vaginal pain secondary to pelvic muscle spasms.There was a consideration of whether the problem could be related to scar tissue from mesh procedures, but there were no findings on imaging and the patient was advised mesh removal attempt should only be performed by a urogynecologist if at all.The patient was advised to continue pelvic floor therapy as that was providing some beneficial results.

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) medical center.(b)(6).Block h6: patient codes e2328, e1301, e1405, e2330, e1720, e2326, e1310, e1901 and e1605 capture the reportable events of stone formation, dysuria, dyspareunia, pain, prurigo nodularis, cystitis, pyelonephritis, bacterial vaginosis, and spasms.Impact code f2303 captures the reportable event of medications given to the patient.Block h10: the complainant indicated that the device was implanted and 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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Brand Name

PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM

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

MDR Report Key

12379888

MDR Text Key

268667695

Report Number

3005099803-2021-04395

Device Sequence Number

Product Code

OTP

Combination Product (y/n)

PMA/PMN Number

K122459

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative,consum

Type of Report

Initial,Followup

Report Date

09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

08/27/2021

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

01/31/2015

Device Model Number

M0068317170

Device Catalogue Number

831-717

Device Lot Number

ML00000441

Was Device Available for Evaluation?

Date Manufacturer Received

08/30/2021

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

47 YR

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

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