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

Model Number M0068507000

Device Problem Defective Device (2588)

Patient Problems Erosion (1750); Purulent Discharge (1812); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Dyspareunia (4505)

Event Date 12/01/2009

Event Type  Injury  

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) medical center; (b)(6).Revision surgery surgeon: dr.(b)(6).(b)(6) hospital (b)(6); (b)(6).Block h6: imdrf patient codes e2006, e2328, e2330, e1310, e1405, e1715 and e2326 capture the reportable events of exposed mesh; foreign body in vagina; urethral lysis; pain; vaginal scarring and urethral scarring; inflammation; dyspareunia and infection.Imdrf impact codes f1903 and f1901 mesh removal and urethral lysis procedure.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-02337 for the uphold mesh device.It was reported to boston scientific corporation that an uphold vaginal support system and solyx sis system devices were implanted into the patient during a total vaginal hysterectomy + bilateral salpingo - oophorectomy + anterior vaginal repair + uphold graft insertion + solyx sis sling insertion + cystoscopy procedure performed on (b)(6) 2009 to treat incomplete uterovaginal prolapse and stress urinary incontinence.The patient was transferred to the recovery room in satisfactory condition.On (b)(6) 2016, the patient underwent bilateral paravaginal dissection, bilateral pararectal dissection, removal of uphold and solyx sling, urethral lysis, removal of mesh, dissection of the deep obturator muscles, anterior and posterior colporrhaphy due to vaginal pain, dyspareunia, vaginal scarring, exposed mesh, vaginal prolapse, urethral scarring and foreign body in vagina.The physician noted that this was a very complicated and difficult surgery.There was severe scarring from the grossly infected uphold mesh and the ligneous scarring from the chronic inflammation and exposure.The uphold mesh was eroded across the anterior apex and the mesh was black from the chronic exposure.The arms of the infected mesh had foul smelling debris in the tunnels.The mesh was cut in the midline and was dissected cephalad, caudad and laterally initially on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered, and the mesh was dissected laterally as far as possible.On the right, the uphold mesh was bunched up and corded and entering the paravaginal space was difficult due to the scarring from the mesh.The arm was dissected as far lateral as possible into the left vaginal pararectal space, initially on the right and the left and the mesh was dissected further laterally as far as possible deep into the levator muscles and the mesh arms were removed from the pelvic floor muscles initially on the right and then the left.Attention was then focused on the solyx sling.The dissection on the sling mesh was initiated and it was freed from the urethral scar tissue and cut in the midline.Severe urethral scarring was freed with sharp dissection performing a urethral lysis.The mesh was followed laterally, and the right paravaginal space and the mesh was dissected laterally as far as possible within the paravaginal space on the right and then the left.This dissected the solyx sling mesh as far laterally as possible into the obturator internus muscles initially on the right and then the left.With the vaginal paravaginal spaces opened, further dissection and visualization of the mesh trajectory permitted mobilization of the mesh arrowhead anchor within the obturator internus muscles bilaterally and both anchors were removed.The patient tolerated the procedure well and was transferred to the recovery room in excellent 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): BOSTON SCIENTIFIC CORPORATION; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16900292
• MDR Text Key: 314887333
• Report Number: 3005099803-2023-02364
• 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: Other
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• 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: 51 YR
• Patient Sex: Female