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

Device Problem Positioning Problem (3009)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Dyspareunia (4505)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, procedure date, as no event date was reported.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(6).(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 identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains one of four devices used on the same patient: uphold device.It was reported to boston scientific corporation that an uphold vaginal support system (15447765), pinnacle pelvic floor repair kit (15447778), and a solyx sis system (15398181) were used during a laparoscopic hysterectomy, anterior and posterior repair with uphold and pinnacle procedures, retropubic urethropexy with solyx, cystoscopy, enterolysis, and sacrospinous ligament fixation; all performed on (b)(6) 2010 to treat a patient with symptomatic pelvic relaxation, genuine stress incontinence, mild endometriosis, dysmenorrhea, dyschezia and bowel adhesions to the left adnexal area.On (b)(6) 2012, the patient experienced stage 2 cystocele with separation of the mesh from the urethrovesical angle.Anterior repair with mesh and cystoscopy procedures were performed.The patient was taken to the operating room and was prepared for surgery.Foley catheter was placed and an inverted u incision was then performed after injection with an ampule of pitressin and 30 cc of normal saline.Dissection was then performed out to the arcus tendinous on either side was easily performed.The mesh was dissected away in total in the anterior vaginal wall and dissection in the deep pubocervical fascia was then performed.At this point, they decided to invert another uphold mesh and they were able to approximate the arcus tendinous on either side although it was more pronounced on the right than on the left.They were able to attach the uphold to that area and then tailor the uphold so that they could attach it to the mesh that was remaining posteriorly and more superiorly in the operating field.This was done without any complication and interrupted sutures of #2-0 prolene were used to attach this to the mesh that was already placed and then interrupted sutures of #2-0 polysorb was used to attach to the urethrovesical angle and to the anterior vaginal wall.This was done without significant complications and the patient tolerated this well.The area was then irrigated and drained multiple times.The arms of the mesh were cut back laterally and floseal was placed in bed.Running simple stitch of #2-0 polysorb was used to close the vagina after placing floseal into the wound site with good hemostasis being noted.Cystoscope was then performed.Bilateral ureteral jets were noted.Otherwise, normal bladder was noted.No evidence of trauma to the bladder and the mucosa were noted.Foley catheter was placed.Vaginal packing was placed in the vagina with metronidazole ointment.The patient was extubated and was then taken to the recovery room in stable condition.On (b)(6) 2014, the patient complained of dyspareunia and chronic pelvic pain.Upon examination, it was noted that there were banding of the uphold mesh from the anterior vagina to the sacrospinous ligament and banding from the posterior rectal vaginal mesh to the sacrospinous ligament on the left side.Vaginal exploration, mesh resection and cystoscopy procedures were performed.The patient was taken to the operating room and prepped for surgery.Locating the area of irritation having examined the patient a day prior the procedure, it was easy to locate the vagina at approximately 8 o'clock region approximately 2/3 of the way up to the top of the vagina.A vertical incision was then performed with blunt and sharp dissection down to the banding area using metzenbaum scissors.The mesh arms were then released.This was done twice with both sets of mesh.Good support was noted; regardless, the area was irrigated and drained multiple times.Palpation down to the sacrospinous ligament was also evaluated and release of pressure from the banding that was occurring was noted.Floseal was placed into the space down to the sacrospinous ligament on the right side and then a running simple stitch of #2-0 vicryl was used to close the incision in the vagina which was approximately three centimeters long.The vagina was then packed foley catheter having been placed earlier to help with hemostasis in the area.Metronidazole ointment was placed on the vaginal pack.The patient was extubated and was then taken to the recovery room.On (b)(6) 2015, the patient experienced dyspareunia and uphold right arm tethering from the mesh.Upon examination it was noted that the patient had bilateral ureteral jets with no evidence of encroachment into the bladder.A removal of mesh and fibrous tissue in the right sidewall of the vagina was planned by the physician.Vaginal exploration, mesh resection and cystoscopy procedures were then performed.The patient was taken to the operating room and was prepared for surgery.A foley catheter was placed and vaginal exploration along the right vaginal sidewall form the middle third was performed superiorly.The physician could feel the tethering about one centimeter below the vaginal mucosa and this was dissected cut.Portions of the mesh were removed and the area was transected.Good hemostasis was noted.The are was then irrigated and drained multiple times.A running simple stitch of #2-0 vicryl was used to close the area.A cystoscopy was then performed showing no evidence of encroachment into the bladder with the bilateral ureteral jetes.Rectal examination throughout the procedure was performed and it revealed no evidence of encroachment into the rectum during the procedure.The procedure took approximately an hour to dissect the area out and veriy that the dissection was okay.The patient was then taken to the recovery room in stable condition.A follow up check up was scheduled on friday after the procedure for removal of the vaginal packing.The patient was discharged and was prescribed with ciprofloxacin 500 mg one tablet, two times a day by mouth.A foley catheter leg bag as well as normal discharge precautions and medications were also prescribed.On (b)(6) 2018, the patient was experiencing chronic pelvic pain with complication of vaginal mesh graft.Although there were multiple areas of the vagina that were contracted on exam under anesthesia, they were able to identify the site that had been palpated in clinic as the most painful.At that location, they found vaginal mesh that was under tension.A vaginal mesh excision procedure was then performed which released the tension without injuring any of the underlying structures.This site was away from the bladder, quite lateral and away from the ureter and therefore, no cystoscopy was performed.The patient was brought to the operating site and was prepared for surgery.Good general anesthesia was induced.The area of concern was palpated once more and marked using a marking pen.A foley catheter was replaced simply to identify the bladder and bladder neck.The area on either side of the marked specimen was now grasped with a long allis and injected with lidocaine and bupivacaine solution.A two centimeter incision with a scalpel was made and they used a tonsil clamps to mobilize on either side of the incision.A finger was placed inside and they could feel that there was a sharp taut area.This was dissected out again using tonsils and metzenbaums with a right angle clamp placed behind.Using the clamp to protect the underlying structures, this was then divided with a long #15 blade scalpel and a popping effect was noted.Several small areas of mesh were now excised again taking care not to affect any of the underlying structures.At the end, they could feel no more sharp areas through the incision made.The incision was three centimeter at the end of the procedure and was closed with interrupted #2-0 vicryl.The patient was awakened and taken to the recovery room in stable condition.Specimen included vaginal mesh which was sent to pathology.There were no patient complications noted.The patient received two grams of ancef for prophylaxis before the incision.The patient also had dvt prophylaxis with scds.The vaginal foley was then removed at the end of the procedure.

• 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): 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: 15199810
• MDR Text Key: 297610202
• Report Number: 3005099803-2022-04458
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• 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): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female