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 Injury (2348); No Code Available (3191); Urethral Stenosis/Stricture (4501); Insufficient Information (4580)

Event Date 10/16/2013

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(4).The removed mesh 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 during a cystoscopy, posterior vaginal repair, retropubic sling advantage placement, vault suspension, sacrospinous fixation, and bilateral procedure performed on (b)(6) 2013.As reported by the patient's attorney, on (b)(6) 2014, the patient underwent minor mesh excision due to voiding dysfunction.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted into the patient during a cystoscopy, posterior vaginal repair, retropubic sling advantage placement, vault suspension, sacrospinous fixation, and bilateral procedure performed on (b)(6) 2013.On (b)(6) 2014, the patient underwent minor mesh excision due to voiding dysfunction.Cystoscopy revealed some trabeculations, but no perforation was noted.

Manufacturer Narrative

Block b5 has been updated based on the additional information received on october 13, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant/mesh excision surgeon is: dr.(b)(6); (b)(6) hospital.Block h6: patient codes e1307 and e2401capture the reportable events of trabeculations and voiding dysfunction.Impact code f1905 captures the event of mesh excision.

• 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
• 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: 11138550
• MDR Text Key: 225718328
• Report Number: 3005099803-2020-06588
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: ML00001603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female