MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502110

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

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Scar Tissue (2060); Dyspareunia (4505)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; 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 advantage fit system was implanted into the patient for the treatment of cystocele, rectocele and stress urinary incontinence (sui) with urethral hypermobility during a mid-urethral sling implantation procedure performed on (b)(6) 2017.According to the complainant, the patient underwent a revision surgery on (b)(6) 2018 due to vaginal scarring and vaginal banding.She opted for the vaginal banding to be removed.During the procedure, underneath the vaginal mucosa, an area of scar tissue and banding was noted.The band located on the vaginal mucosa and anterior part was incised longitudinally and was released to prevent recurrence of banding.The procedure was successfully completed and the patient was in stable condition.

Manufacturer Narrative

Correction to b1, b5 and h6 - the adverse event/product problem field was updated to adverse event, and the event of dyspareunia was added as one of the patient's symptoms since it was mentioned in the medical records that the revision surgery which was removing the banding, was to check if it improves the patient's ability to have intercourse.E1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6)hospital, stone brook, ny by dr.(b)(6).H6: patient codes e1715, e2101, e0506, and e1405, capture the following reportable events of scar tissue, adhesions, hemorrhage and dyspareunia.Impact code f19 captures the reportable event of surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.H10: the complaint device is not expected to be returned for evaluation.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 corporatiion that an advantage fit system was implanted into the patient for the treatment of cystocele, rectocele and stress urinary incontinence (sui) with urethral hypermobility during a mid-urethral sling implantation procedure performed on (b)(6) 2017.According to the complainant, the patient underwent a revision surgery on (b)(6) 2018 due to vaginal scarring and vaginal banding.She opted for the vaginal banding to be removed, this is to check if it improved the patient's ability to have intercourse.During the procedure, underneath the vaginal mucosa, an area of scar tissue and banding was noted.The band located on the vaginal mucosa and anterior part was incised longitudinally and was released to prevent recurrence of banding.The procedure was successfully completed and the patient was in stable condition.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11409032
• MDR Text Key: 234650480
• Report Number: 3005099803-2021-00879
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0020787408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR