MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Perforation (2001); Scar Tissue (2060); Prolapse (2475); Dyspareunia (4505); Fecal Incontinence (4571)

Event Date 12/15/2010

Event Type  Injury  

Event Description

Patient history: the patient had a history of a total abdominal hysterectomy and left salpoophorectomy sometime in 2000.It was reported to boston scientific corporation that a solyx sis system was used during a solyx sis sling and posterior colporrhaphy procedures performed on (b)(6) 2010 to treat a patient with complaints of worsening stress urinary incontinence where the patient had bladder cystometrics performed in the clinic.The patient is also being treated for second-degree symptomatic rectocele which made it difficult for the patient to pass stool at times.On (b)(6) 2021, the patient was referred for vault prolapse with a cystocele and rectocele, some fecal incontinence and pain with intercourse.The patient was also referred due to left lower quadrant pain and colonoscopy findings.The patient agreed to have the adhesions freed on the left side of the pelvis, but did not opt for a mesh repair of her rectocele by concern that her incontinence would not resolve or might get worse.The physician freed all the adhesions along the patient's colon.It was noted that the patient had a very redundant sigmoid as well.Multiple pelvic adhesions were attached to the vaginal cuff.The colon was then freely mobilized and some areas of the scar were excised.The physician proceeded with an exposure of the promontory with a 30-degree down lens.A fair amount of fat in front of the promontory was noted which was easy to identify along with the prolapse.A peritoneal flap was elevated medially.The rectovaginal space was freed all the way down to the point where scarring was encountered due to prior posterior repair as confirmed on vaginal inspection.The dissection then was carried out anteriorly where the scar tissue was noted (part related to the hysterectomy and possibly some attempt at prior repair there as well).The anterior dissection was limited due to the dense scarring within the vaginal wall.The exposure was sufficient to place the mesh there.Bard mesh was prepared after being soaked in antibiotic solution.A two centimeter segment was selected anteriorly and five centimeter posteriorly with a width at four centimeter.The front and back segment of the mesh was secured together with a 2-0 prolene suture, and the extremity of each mesh segment was secured with a 2-0 vicryl suture.The mesh was configured in that fashion and was brought down through the assistant port.The back portion of the mesh was secured first to the back wall of the vagina and additional reinforcement proximally toward the vaginal cuff.After this was done, the front part of the mesh was secured to the front part of the anterior vaginal wall and cuff.When the mesh was well attached to the front and back vaginal apex, the upper part of the mesh was then secured to the promontory and the exposed anterior vertebral ligament earlier on.At that point, the mesh was retroperitonealized in an inverted t-shaped fashion.After the closure was done and the mesh was retroperitonealized, pressure was dropped in the pelvic cavity and they closed the area where scar tissue has been excised.When they were done with the robotic procedure, attention was focused to the vaginal area.They first noticed an excellent repair from the prolapse with no residual cystocele or rectocele visible.A midline posterior incision of the posterior vaginal wall was confirmed, suggesting that the patient underwent a prior posterior repair at some point.Interiorly, the mesh was palpable, but it was clearly seen by a vaginoscopy.Several clear fibers were exposed on the right side of the proximal urethral region.Cystoscopy was performed and at the end of the robotic procedure and again at the start of the mesh sling removal.The cystoscopy revealed no bladder injury during the robotic repair, and good efflux return from both ureteric orifices and a flattened urethra from the sling high up in the proximal region.A short transverse incision was made, and the proximal level of the sling was exposed.The exposed fibers were excised with the sling underneath.It was curled as shown on the preoperative ultrasound and going laterally to the obturator foramen.The sling was tracked to the inferior arch of the pubic symphysis, where it was divided there.After the right side was done, the left side was dissected in a similar fashion, although laterally and as lateral as they could safely go until the sling disappeared onto the obturator space.After the sling removal was completed, cystoscopy was repeated to ensure no urethral wall damaged, which was the case, and a wide open urethral lumen.There was no bleeding.Vaginal incision was closed.The vagina was packed with antibiotic-soaked gauze.The patient was awakened and was taken to the recovery room in good condition.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, implant date date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explant surgeon is: dr.(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.

Manufacturer Narrative

Block h2: correction.Block b5 narrative updated.Block h6 patient codes e2114 and e1405 for perforation and dyspareunia.Impact code f1901 for additional surgery.Block b3 date of event: date of event was approximated to december 15, 2010, 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.Michael sims (b)(6).The explant surgeon is: dr.(b)(6).Block h6: patient code e2101 captures the reportable event of adhesion.Patient code e1715 captures the reportable event of vaginal scarring.Patient code e2330 captures the reportable event of pain.Patient code e2006 captures the reportable event of erosion.Impact code f1905 captures the reportable event of revision or replacement.Impact code f1909 captures 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 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

Patient history: the patient had a history of a total abdominal hysterectomy and left salpoophorectomy sometime in 2000.It was reported to boston scientific corporation that a solyx sis system was used during a solyx sis sling and posterior colporrhaphy procedures performed on (b)(6) 2010 to treat a patient with complaints of worsening stress urinary incontinence where the patient had bladder cystometrics performed in the clinic.The patient is also being treated for second-degree symptomatic rectocele which made it difficult for the patient to pass stool at times.Following solyx placement, the vaginal vault was thoroughly inspected and a small 0.5cm tear or puncture was noted in the right vaginal sulcus on the right side.There was not evidence of any mesh extrusion though this area, and the area was oversewn with 2 figure-of-eight stitches of 2-0 vicryl to achieve hemostasis.On (b)(6) 2021, the patient underwent robotic adhesiolysis, robotic mesh sacrocolpopexy (non-bsc mesh), cystoscopy, transvaginal removal of exposed vaginal sling, and repeat cystoscopy for the preoperative diagnoses of vault prolapse, grade 2 cystocele, grade 2 rectocele, sigmoidocele, and exposed vaginal sling.The patient had been referred for vault prolapse with a cystocele and rectocele, some fecal incontinence and pain with intercourse.The patient was also referred due to left lower quadrant pain and colonoscopy findings.The patient agreed to have the adhesions freed on the left side of the pelvis but did not opt for a mesh repair of her rectocele by concern that her incontinence would not resolve or might get worse.The physician freed all the adhesions along the patient's colon.It was noted that the patient had a very redundant sigmoid as well.Multiple pelvic adhesions were attached to the vaginal cuff.The colon was then freely mobilized and some areas of the scar were excised.The physician proceeded with an exposure of the promontory with a 30-degree down lens.A fair amount of fat in front of the promontory was noted which was easy to identify along with the prolapse.A peritoneal flap was elevated medially.The rectovaginal space was freed all the way down to the point where scarring was encountered due to prior posterior repair as confirmed on vaginal inspection.The dissection then was carried out anteriorly where the scar tissue was noted (part related to the hysterectomy and possibly some attempt at prior repair there as well).The anterior dissection was limited due to the dense scarring within the vaginal wall.The exposure was sufficient to place the mesh there.Bard mesh was prepared after being soaked in antibiotic solution.A two centimeter segment was selected anteriorly and five centimeter posteriorly with a width at four centimeter.The front and back segment of the mesh was secured together with a 2-0 prolene suture, and the extremity of each mesh segment was secured with a 2-0 vicryl suture.The mesh was configured in that fashion and was brought down through the assistant port.The back portion of the mesh was secured first to the back wall of the vagina and additional reinforcement proximally toward the vaginal cuff.After this was done, the front part of the mesh was secured to the front part of the anterior vaginal wall and cuff.When the mesh was well attached to the front and back vaginal apex, the upper part of the mesh was then secured to the promontory and the exposed anterior vertebral ligament earlier on.At that point, the mesh was retroperitonealized in an inverted t-shaped fashion.After the closure was done and the mesh was retroperitonealized, pressure was dropped in the pelvic cavity and they closed the area where scar tissue has been excised.When they were done with the robotic procedure, attention was focused to the vaginal area.They first noticed an excellent repair from the prolapse with no residual cystocele or rectocele visible.A midline posterior incision of the posterior vaginal wall was confirmed, suggesting that the patient underwent a prior posterior repair at some point.Interiorly, the mesh was palpable, but it was clearly seen by a vaginoscopy.Several clear fibers were exposed on the right side of the proximal urethral region.Cystoscopy was performed and at the end of the robotic procedure and again at the start of the mesh sling removal.The cystoscopy revealed no bladder injury during the robotic repair, and good efflux return from both ureteric orifices and a flattened urethra from the sling high up in the proximal region.A short transverse incision was made, and the proximal level of the sling was exposed.The exposed fibers were excised with the sling underneath.It was curled as shown on the preoperative ultrasound and going laterally to the obturator foramen.The sling was tracked to the inferior arch of the pubic symphysis, where it was divided there.After the right side was done, the left side was dissected in a similar fashion, although laterally and as lateral as they could safely go until the sling disappeared onto the obturator space.After the sling removal was completed, cystoscopy was repeated to ensure no urethral wall damaged, which was the case, and a wide open urethral lumen.There was no bleeding.Vaginal incision was closed.The vagina was packed with antibiotic-soaked gauze.The patient was awakened and was taken to the recovery room in good condition.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 15075163
• MDR Text Key: 296310569
• Report Number: 3005099803-2022-03993
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML0071501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female