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 Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 that an uphold was implanted on (b)(6) 2014 and a solyx was implanted on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008 the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017 the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.Device 2 of 2.

Manufacturer Narrative

Blocks a1, b5 and d4 lot number have been updated based on the additional information received on november 17, 2022.Block b3 date of event: date of event was approximated to september 11, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeons are (b)(6) dr.(b)(6) dr.(b)(6) campus.Block h6: imdrf patient codes e2006, e2330, e1405 and e1401 capture the reportable events of erosion, pain, dyspareunia and abnormal vaginal discharge.Imdrf impact codes f19 capture the reportable event of surgical intervention.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a solyx sling procedure with cystoscopy + posterior vaginal repair with excision of old mesh from posterior vaginal wall + excision of previous monarc mesh performed on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; other pain: lower abdominal pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury surgical interventions: on (b)(6) 2017, the patient underwent further surgery regarding the pinnacle mesh implant under general anesthesia for the following purpose: excision.Nonsurgical treatments: on (b)(6) 2008, the patient commenced pain medication: panadol and nurofen for the treatment of: pain.Treatment duration: ongoing.On (b)(6) 2008, the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: incontinence.On (b)(6) 2017, the patient commenced topical treatment (including oestrogen cream): cream (eleuthrat and vagifem) and pessaries (two lots).Treatment duration: 4 years straight and previously sporadically.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12930744
• MDR Text Key: 286919431
• Report Number: 3005099803-2021-07392
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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: 01/18/2020
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0020177312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG