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

Model Number M0068318170

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

Patient Problems Micturition Urgency (1871); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Vomiting (2144); Discomfort (2330); Numbness (2415); Prolapse (2475); Dysuria (2684); No Code Available (3191); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was implanted during a vaginal anterior repair with mesh and cystoscopy procedure performed on (b)(6) 2016.As reported by the patient's attorney, post procedure, the patient's chronic pain was attended, and was given with ibuprofen as needed.She was also suffering with intermittent nausea and vomiting and was given anti-emetics.On (b)(6) 2016, the patient was receiving well with regards to anterior repair with uphold mesh.Furthermore, the patient was experiencing tenderness in her lower abdomen.She also experienced episodes of urinary urgency.On (b)(6) 2017, the patient underwent vaginal repair with revision of uphold mesh.She experienced occasional pelvic pain, and difficulty in initiating urinary stream but feels that she was able to empty her bladder effectively.She has no abnormal vaginal discharge or bleeding.She has attempted coitus and had some discomfort but was ot sexually active at this stage.On october 10, 2017, the patient reported that she experienced upset feeling of pelvic organ prolapse (pop) in the last weeks.The patient was in pain and it was observed that there was a descent of the anterior wall.

Manufacturer Narrative

Correction to blocks b5 and h6 - the event of prolapse was added to report recurrent prolapse as one of the patient's symptoms and urinary urgency was removed since this was pre-existing to the patient's surgery, and was not noted to be worsened.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: dr.(b)(6).Block h6: patient code e2330 captures the reportable event of pain.Impact code f19 captures the reportable event of 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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was implanted during a vaginal anterior repair with mesh and cystoscopy procedure performed on (b)(6) 2016.As reported by the patient's attorney, post procedure, the patient's chronic pain was attended, and was given with ibuprofen as needed.She was also suffering with intermittent nausea and vomiting and was given anti-emetics.On november 16, 2016, the patient was receiving well with regards to anterior repair with uphold mesh.Furthermore, the patient was experiencing tenderness in her lower abdomen.She also experienced episodes of urinary urgency, however, this was already pre-existing and was not worsened.On (b)(6) 2017, the patient underwent vaginal repair with revision of uphold mesh.She experienced occasional pelvic pain, and difficulty in initiating urinary stream but feels that she was able to empty her bladder effectively.She has no abnormal vaginal discharge or bleeding.She has attempted coitus and had some discomfort but was ot sexually active at this stage.On (b)(6) 2017, the patient reported that she experienced upset feeling of pelvic organ prolapse (pop) in the last weeks.The patient was in pain and it was observed that there was a descent of the anterior wall.

Event Description

It was reported to boston scientific corporation that an uphold (tm) lite with capio slim was implanted during an anterior vaginal wall repair with mesh (uphold lite) and cystoscopy procedure performed on (b)(6), 2016, for the treatment of recurrence of anterior vaginal wall prolapse.As reported by the patient's attorney, post procedure, the patient's chronic pain was attended, and was given with ibuprofen as needed.She was also suffering with intermittent nausea and vomiting and was given anti-emetics.On (b)(6), 2016, the patient was receiving well with regards to anterior repair with uphold mesh.Furthermore, the patient was experiencing tenderness in her lower abdomen.She also experienced episodes of urinary urgency; however, this was already pre-existing and was not worsened.On (b)(6), 2017, the patient underwent vaginal repair with revision of uphold mesh.She experienced occasional pelvic pain, and difficulty in initiating urinary stream but feels that she was able to empty her bladder effectively.She has no abnormal vaginal discharge or bleeding.She has attempted coitus and had some discomfort but was not sexually active at this stage.The patient was referred in (b)(6) 2017 to the neurosurgery clinic.She was seen by an advanced musculoskeletal physiotherapist within the neurosurgery outpatient clinic.On (b)(6), 2017, the patient reported that she experienced upset feeling of pelvic organ prolapse (pop) in the last weeks.The patient was in pain, and it was observed that there was a descent of the anterior wall.Her symptoms as of (b)(6), 2017, were that of vaginal prolapse, pressure and dragging sensation as well as pain that radiates into her legs.She also had described some vaginal pain and finds vaginal examination quite uncomfortable.The patient had not been sexually active because of the vaginal pain.Intermittently, she also had rectal pain, but it was noted that she has not had any posterior wall mesh prosthesis placed.In terms of urinary symptoms, she denied any voiding difficulty and had normal daytime and nighttime urinary frequency but has urge incontinence 2x to 3x/day every second day however with no stress incontinence.It was noted that she had previously tried some topical vaginal estrogens but was not able to tolerate it due to migraines.On examination, whilst the physician was unable to see any obvious erosions, there were some rough areas in the midline of vagina which could be a scar tissue.The physician was also able to palpate the upper edge of the mesh prosthesis and traced it along the lateral walls down towards the sacrospinous ligament which could be consistent with the mesh attaching to the sacrospinous ligament.The patient indicated that it was quite tender to palpate along this line.A sim's speculum examination demonstrated a small stage ii cystocele descending to 1cm above the introitus, a high rectocele which descended to the introitus but there was reasonable vault support.Considering these findings, urodynamics study was first recommended by the physician and it was sent off to msu for discussion of urge incontinence.Regarding her recurrent prolapse, vaginal pain and dyspareunia, the physician suggested a 3d ultrasound to image the mesh and examination under anesthesia with cystoscopy.It was also indicated that if the patient was keen to have the "band" of mesh excised, one of the risks would be increasing her risk of anterior wall recurrence and she will certainly take this into consideration but first they will perform their investigations.On (b)(6), 2017, the patient underwent examination under anesthesia and cystoscopy for the diagnosis of dyspareunia.The operative findings revealed excellent lower anterior support, vault prolapse with enterocele, and anterior wall with no areas of mesh erosion or tethering felt, however, the mesh arm was palpable below the level of enterocele tracking to sacrospinal ligament bilaterally which meant that the mesh was appropriately placed.Furthermore, there was no area of peri-urethral mesh or erosion palpable vaginally, and the cystoscopy and urethroscopy results were normal.Urodynamics done in (b)(6) 2018 showed that the patient had a stable detrusor muscle and was able to accommodate 500ml of filling in the bladder, but she did not demonstrate any normal desire at that volume.She had no leakage and no voiding dysfunction evident.The patient's main concern was trying to establish somewhat normal routine again.Her main symptom was really pain, specifically bottom pain that she described as sometimes debilitating but alternately some days were good.She was also concerned with her incontinence or prolapse symptoms.Additionally, she has quite a stoic personality and in the context of the pain, she is currently just putting up with these symptoms.It was noted that the patient was taking lyrica and panadol osteo for her pain and did have a history of other drug allergies.She had not yet seen a pain specialist and she came to discuss her pain management.The patient was also describing some incontinence of gas since her very first surgery and had never had a colonoscopy.Her mother died from advanced bowel cancer, and it sounds like she had been recommended to have a genetic testing t, but this has not been arranged yet.On (b)(6), 2018, the patient's current problems were vaginal pain, bowel pain, dyspareunia, recurrent prolapse and urinary incontinence.Her recent urine done in (b)(6) was clear with no hematuria.The patient has had a perineal 2d and 3d ultrasounds done showing good placement of the anterior vaginal mesh with flat non-folded mesh.There was a possibility that a cystocele was seen sliding below the level of the mesh and no significant mesh movement.On (b)(6), 2019, the patient's main priority was for consideration of having all her previous transvaginal and vaginal meshes removed.She has a history of tvt-o (transobturator sling) for stress urinary incontinence inserted in 2010, and an anterior vaginal mesh (prosima a) was inserted as a concomitant procedure at the same time in 2010.She then underwent a native tissue repair without insertion of prosthesis in 2013, however, following recurrence of prolapse, she went on to have an anterior vaginal mesh in 2016 (uphold lite).The patient's primary symptoms include a variety of different pains including pain at the leg and groin bilaterally with difficult sitting for prolonged periods of time and difficulty moving to sit to stand and standing at times.She described sharp pain which can be generalized and can radiate down the legs at times as well as back pain and the pain in the back passage.In addition to this, she described some right-sided pain in the buttock which was predominant on the right as well as some nausea at times.On examination, she was tender over the right obturator region as well as the right sacrospinous ligament where the mesh can be palpated descending down to the right sacrospinous ligament.There was no folding or nodularity to the mesh on the anterior wall on examination; however, this would be better assessed under an anesthetic.Following on from this, the patient was still keen to pursue the possibility of full and total mesh excision.Other current issues included some mild stress urinary incontinence as well as urinary urgency.She has also had recurrent urinary tract infections from last year, although they appeared to have settled with a prolonged course of macrodantin.In addition to this, she has reasonably longstanding fecal and flatal incontinence which has been present since 2011.She did find that she did have some bowel actions without warning.Also, she had apareunia and was unable to be sexually active at the present time.The patient warrants another examination under anesthetic and cystoscopy with injection of local anesthetic and steroid into the areas that are most problematic.On (b)(6), 2019, the patient underwent examination under anesthesia, insertion of local anesthetic and steroid, and cystoscopy.It was observed that the upper limit of the anterior mesh was felt wherein the uphold was not under tension and can accommodate 3 fingers easily at the apex, and the sacrospinous ligament (ssl) bilaterally felt normal.Naropin 20 mls + depomedrone 40mg + 40 mls of normal saline were injected along the bilateral ssl, anterior wall, mid urethra, and tvto (obturator) path.On (b)(6), 2019, the patient was in for assessment with the diagnosis of longstanding lower back pain with non-radicular leg symptoms, and complex pain issues due to medical complications of prolapse surgery.The patient's main complaint was constant lower back pain, bilateral whole leg pain, numbness and swelling to the legs and arms, and back spasms.This pain limits her function significantly.Lumbar spine ct scans that were visualized on capital imaging from 2017 show degenerative changes affecting mainly the discs and facets at l4-l5 and l5-s1 and no significant canal stenosis or foraminal stenosis.On physical examination, the patient is overweight through the abdomen with slim legs and reduced gluteal bulk.She has limited range through her lumbar spine due to pain approximately 50%.She has normal neurological examination in both upper limbs and lower limbs at this point in time.She has full hip and knee range of movement with no pain.Lastly, the follow-up plan for the patient was to attend pain management services for which she was already enrolled, conservative management which mainly focused on chronic pain behaviors for her back pain, and discharge from the present clinic.

Manufacturer Narrative

Additional information to blocks b5, b7, e1: physician, and h6: patient codes.Block b3 date of event: date of event was approximated to june 27, 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: dr.(b)(6).Block h6: patient codes e1715, e1310, e2330, and e1405 capture the reportable events of scar tissue (cicatrix) (some rough areas in the midline of vagina), infection, urinary tract (recurrent), pain (pain that radiates into her legs, vaginal pain, rectal pain, bowel pain, lower back pain, leg symptoms, chronic pain), and dyspareunia, respectively.Impact codes f19, f22, f23, f2303, and f2203 capture the reportable events of surgical intervention, unexpected diagnostic intervention (examination under anesthesia insertion of local anesthetic & steroid cystoscopy), unexpected medical intervention (advanced musculoskeletal physiotherapist, pain management), medication required (topical vaginal estrogens, macrodantin for uti, lyrica and panadol osteo for her pain), and imaging required (lumbar spine ct scans, perineal 2d and 3d ultrasounds), respectively.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 failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 11139571
• MDR Text Key: 225876169
• Report Number: 3005099803-2021-00024
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female