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 Defective Device (2588)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Perforation (2001); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 12/23/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009 was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Physician in-charged of revision surgery: dr.(b)(6).The following imdrf patient codes capture the reportable event of: e2006 - extrusion, e2114 - suspected right ureteral injury, e2330 - pain, e2326 - inflammation, e2401 - bladder lesion, e1405 - dyspareunia.The following imdrf impact codes capture the reportable event of: f1905 - device revision or replacement, f1903 - device explantation, f1901 - additional surgery.

Event Description

It was reported to boston scientific corporation that uphold vaginal support system was implanted into the patient during an uphold vaginal suspension with insertion of mesh, anterior and posterior repair, perineorrhaphy procedures, and tvt midureteral suspension with an unknown boston scientific device on (b)(6) 2009 for the treatment of cystocele, rectocele and enterocele.There were no reported complications throughout the procedure, and an excellent hemostasis was observed.Following the procedure, the patient had postcoital bleeding, dyspareunia, vaginal atrophy/atrophic vaginitis, and a partial extrusion of an edge of the uphold mesh through the vaginal mucosa, which bled on palpation.Subsequently, the patient underwent a partial excision of uphold mesh on (b)(6) 2012.An examination under anesthesia during the surgery reveals a well-supported apex,no cystocele or rectocele, and vaginal atrophy.There was a 4mm superior/inferior and 2cm transversally extruded mesh erosion.Furthermore, using a scalpel and metzenbaum scissors, the mesh was grasped and sharply dissected from the vaginal mucosa.Superiorly and inferiorly, the vaginal mucosa was undermined.To the greatest extent, 4mm of mesh were excised.The vaginal mucosa was further undermined in order to allow for free flaps for coverage.There was excellent hemostasis.There were no palpable areas of mesh prior to or after closure.In addition, the patient had vaginal mesh erosion, pain due to mesh, a narrow vaginal introitus, and posterior vaginal puckering.Further testing revealed stress leakage in office studies, urodynamics, and cystourethroscopy.A bladder lesion was noted on preoperative cystoscopy.The patient desired surgical management and was counseled on the risks, benefits, and alternatives.To address the complications, the patient underwent vaginal mesh removal, left uterosacral ligament suspension, vaginal flap advancement, cystourethroscopy, perineoplasty, and ureteral stent placement and removal on (b)(6) 2016.The vaginal mesh was clearly visible on the anterior aspect of the vagina during the surgery.Moreover, the vaginal introitus was found to be very tight.The mesh's lateral edges, especially on the left side, were causing puckering and inversion of the vaginal tissue.Moreover, the fibromuscular layer was dissected free from the mesh using sharp dissection with mayo scissors.The mesh was notably contracted and able to accommodate a right angle clamp around it.After that, a right-angle clamp was carefully placed behind the mesh and opened to clear off an area of mesh in order to incise the mesh in the midline.Two kocher clamps were then used to secure the mesh.The mesh was then cut through the middle.The mesh on the right side was first sharply dissected away from the vaginal mucosa with metzenbaum scissors.After mobilizing this, blunt dissection was used to palpate along the length of the mesh to the insertion on the sacrospinous ligament.The mesh was found to be diving down towards the sacrospinous ligament.After dissecting as much mesh as possible, the curved mayo scissors were used to cut the mesh as proximally as possible.On the left side, a similar dissection took place.The vaginal epithelium was then found to be folded over itself, and sharp dissection was used to try to release some of the puckering and tethering.Care was taken to preserve as much vaginal tissue as possible.The peritoneal cavity was then clearly identified and entered sharply.The bladder was notably close to the dissection but was not injured.A cystourethroscopy was performed to ensure that there was no damage to the bladder or urethra.Just above and lateral to the right ureteral opening, a small papillary bladder lesion was observed.While the uterosacral ligaments were held in tension, there was a strong left ureteral efflux but no efflux from the right.The uterosacral ligaments were then released, but no ureteral efflux was observed on the right.The bladder was then completely empty, and the vault sutures on the right were removed.Repeat cystoscopy revealed no right ureteral efflux and no trauma at the sidewall where these had been.After removing the internal mccall's culdoplasty stitch, lasix 5mg iv was administered.Yet, there was no efflux on the right side.After positioning the 30-degree scope, a pollack catheter was inserted into the right ureteral orifice.The right ureter appeared to be coursing away from where the most of the mesh dissection had occurred upon palpation of the catheter.A retrograde pyelogram was then conducted after consulting with urology, and it revealed a minimal filling of extravasation into the retroperitoneum in the distal right ureter.In the area next to the ureter, the bladder was thin.According to reports, the patient's family was given the option of immediate repair, nephrostomy tube placement, or delayed repair.The decision was made to proceed with the delayed repair, minimally invasively in conjunction with the pubovaginal sling.The anterior vaginal wall was closed using a continuous, running, locked 2-0 vicryl suture.The vaginal vault suspension sutures were then elevated and tied down to obtain elevation and length for the vagina.Another cystourethroscopy was performed to confirm strong left ureteral efflux.The right ureteral orifice was somewhat erythematous at this point, and the lesion was almost nonexistent, likely due to several attempts at catheterization by the pollack catheter.The tails of the vaginal vault sutures were trimmed in the vagina.Furthermore, the patient tolerated the procedure well.The patient was then taken to recovery room in stable condition.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16649193
• MDR Text Key: 312409850
• Report Number: 3005099803-2023-01606
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female