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

Model Number M0068317080

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

Patient Problems Erosion (1750); Fever (1858); Fistula (1862); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Renal Impairment (4499); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 04/26/2011

Event Type  Injury  

Manufacturer Narrative

The patient's weight at the time of the event was (b)(6) kilograms.This event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Devices were removed by: (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 (bsc) that an uphold vaginal support system was implanted during a total vaginal hysterectomy + bilateral salpingo-oophorectomy + uphold anterior and posterior sacrospinous repair procedure performed on (b)(6) 2011, to treat symptomatic uterine prolapse, cystocele, and rectocele.On (b)(6) 2011, the patient underwent tension free vaginal taping using a non-bsc device through the obturator and excision of vaginal mesh due to stress urinary incontinence and mesh erosion at the vaginal apex.During the procedure, a small area of mesh erosion was noticed at the vaginal apex that was about 1.5 centimeter in length and about 4 millimeter was protruding.The eroded mesh was removed.On (b)(6) 2019, patient underwent a bilateral cystoscopy, retrograde pyelogram, cystoscopy with removal of bladder stones.During cystoscopy procedure, it was discovered that the stones were attached to suture and mesh material underneath the bladder base behind the trigone.Reportedly, patient had a urinary tract infection.On (b)(6) 2020, patient underwent a cystoscopy, bilateral ureteral stent placement, removal of mid-urethral, urethroplasty, removal of transvaginal mesh, closure of cystotomy, martius flap, and repair of ureterotomy due to an eroded mid urethral sling into the urethra and two areas of mesh erosion in the bladder.All visible mesh that eroded into the bladder was completely excised.The mesh that was attached to the right ureter was able to be removed.A small urethrotomy was made and the ureter was repaired and stented.On (b)(6) 2020, patient underwent cystoscopy, bilateral ureteral pyelograms, right ureteral reimplantation, right distal ureterectomy, rectus fascia pubovaginal sling repair of ureterovaginal fistula due to right ureterovaginal fistula and severe stress urinary incontinence.On (b)(6) 2020, the patient was admitted due to pyuria, acute kidney injury, fever, postoperative infection, and sepsis.She was started on broad spectrum antibiotics as treatment.The patient was stable upon discharge.On (b)(6) 2020, patient underwent wound exploration and placement of wound vacuum due to chronic abdominal wound infection.The patient abdominal wall has fluid collection that is persistent and has become infected.Reportedly, the patient was transferred to post anesthesia recovery unit in a stable condition.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted during a total vaginal hysterectomy + bilateral salpingo-oophorectomy + uphold anterior and posterior sacrospinous repair procedure performed on (b)(6) , 2011, to treat symptomatic uterine prolapse, cystocele, and rectocele.On (b)(6) , 2011, the patient underwent tension free vaginal taping using a non-bsc device through the obturator and excision of vaginal mesh due to stress urinary incontinence and mesh erosion at the vaginal apex.During the procedure, a small area of mesh erosion was noticed at the vaginal apex that was about 1.5 centimeter in length and about 4 millimeter was protruding.The eroded mesh was removed.On (b)(6) , 2019, patient underwent a bilateral cystoscopy, retrograde pyelogram, cystoscopy with removal of bladder stones.Reportedly, the patient had experienced recurrent urinary tract infections prior to identification of bladder stones via ct.During cystoscopy procedure, it was discovered that the stones were attached to suture and mesh material underneath the bladder base behind the trigone.On (b)(6) , 2020, patient underwent a cystoscopy, bilateral ureteral stent placement, removal of mid-urethral sling, urethroplasty, removal of transvaginal mesh, closure of cystotomy, martius flap, and repair of ureterotomy due to an eroded mid urethral sling into the urethra and two areas of mesh erosion in the bladder.There were calcification in the bladder attached to the mesh.All visible mesh that eroded into the bladder was completely excised.The mesh that was attached to the right ureter was able to be removed.A small ureterotomy was made and the ureter was repaired and stented.Reportedly, a 300cc of blood loss was estimated during this procedure.On (b)(6) 2020, patient underwent cystoscopy, bilateral ureteral pyelograms, right ureteral reimplantation, right distal ureterectomy, rectus fascia pubovaginal sling repair of ureterovaginal fistula due to right ureterovaginal fistula and severe stress urinary incontinence.On (b)(6) , 2020, the patient was admitted due to pyuria, acute kidney injury, fever, postoperative infection, and sepsis.She was started on broad spectrum antibiotics as treatment.Pain was well controlled with oral medication.The patient was stable upon discharge.On (b)(6) , 2020, patient underwent wound exploration and placement of wound vacuum due to chronic abdominal wound infection.The patient's abdominal wall had fluid collection that was persistent and had become infected.Wound culture showed multiple organisms, but predominantly showed e.Coli.Local wound care was unsuccessful, so she was referred for further treatment at which time she underwent wound exploration under anesthesia with placement of the wound vac.Reportedly, the patient was transferred to post anesthesia recovery unit in a stable condition.She was to follow up as an outpatient.

Manufacturer Narrative

Correction to blocks b5 and h6 - the events of extrusion and fistula were added.Additionally, renal impairment will be used instead of injury, not otherwise specified (nos) to better capture acute kidney disease and urinary urgency was removed.Block a4: the patient's weight at the time of the event was 79.4 kilograms.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.Bryan k.Perkins indiana surgery center south devices were removed by: dr.Victor w.Nitti ronald reagan ucla medical center block h6: patient codes e0306, e2006, e1305, e1310, e2115, e1906, e0506, e2314, e2328, and e2330 capture the reportable events of sepsis, erosion/extrusion, acute kidney disease, urinary tract infection, post-operative wound infection, pyelonephritis, hemorrhage, fistula, ureter/urethral obstruction, and pain.Impact code f19 capture the reportable event of 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 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 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: 11410281
• MDR Text Key: 234610052
• Report Number: 3005099803-2021-00903
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 1ML0111102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR