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 Erosion (1750); Injury (2348); Unspecified Tissue Injury (4559)

Event Date 03/28/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to march 28, 2015, implant date, as no event date was reported.Two lot numbers are provided by the customer and it is unknown which one was implanted into the patient.See details below.Brand name: advantage fit system upn: m0068502110 lot #: ml00002333 manufacture date: 05/08/2014 use before date/expiration: 05/31/2017 brand name: advantage fit system upn: m0068502110 lot #: ml00002313 manufacture date: 05/01/2014 use before date/expiration: 05/31/2017 this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Patient code (b)(4) captures the reportable event of unknown injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.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

Note: this manufacturer report pertains to the first of two devices used during the procedure.It was reported to boston scientific corporation that an advantage fit system device and an upsylon y-mesh kit was implanted into the patient during a robotic adhesiolysis and sacrocolpopexy + removal of mesh exposure (non-bsc mesh) + midurethral sling (advantage fit tape) placement + cystoscopy + fitting a vaginal support device performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Block h2: additional information.Blocks b2 (outcomes attrib to adv event), b5 (narrative), d6b (explant date), e1 (initial reporter) and h6 (patient anf impact codes) has been updated based on the additional information received february 10, 2023.Correction: blocks g2 (report source) and h6 (evaluation conclusion codes) has been corrected.Block b3 date of event: date of event was approximated to march 28, 2015, implant date, as no event date was reported.Blocks d4, h4: two lot numbers are provided by the customer and it is unknown which one was implanted into the patient.See details below.Brand name: advantage fit system.Upn: m0068502110.Lot #: ml00002333.Manufacture date: 05/08/2014.Use before date/expiration: 05/31/2017.Brand name: advantage fit system.Upn: m0068502110.Lot #: ml00002313.Manufacture date: 05/01/2014.Use before date/expiration: 05/31/2017.Block e1: this event was reported by the patient's legal representation.The implant and explant surgeon is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2015 - capture the reportable event of vaginal atrophy.E2006 - capture the reportable event of mesh exposure.The following imdrf impact code capture the reportable event of: f1905 - capture the reportable event of patient had to undergo revision surgery to address the reported complications.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the procedure.Please refer to mfr report 3005099803-2021-00053 for the associated device.It was reported to boston scientific corporation that an advantage fit system and an upsylon y-mesh kit device was implanted into the patient during a robotic adhesiolysis and sacrocolpopexy + removal of mesh exposure (non-bsc mesh) + midurethral sling (advantage fit tape) placement + cystoscopy + fitting a vaginal support device performed on (b)(6) 2015.The findings of the procedure are as follows: 1.The patient had a very shortened vagina.2.Adhesions of the bowel to the vaginal vault, the anterior abdominal wall, the vault, and the left round ligament remnant.3.Adhesiolysis has to be completed before the laparoscopic sacrocolpopexy dissection could begin (lscp).4.The bladder was so badly adhered to the vault that dissecting it from the vault was challenging.5.Y-shaped upsylon mesh was used for the scp.6.The mesh was secured to the sacral promontory's anterior longitudinal ligament.7.At the end, the vaginal apex, posterior, and anterior walls were all extremely well supported.8.Lower posterior vaginal and perineal repair was deemed to be necessary.9.The cystoscopy was ordinary.On (b)(6) 2019, the patient underwent an exam under anesthesia, removal of mesh exposure, cystoscopy and injection of botox.The findings of the procedure are as follows: 1.Examination under anesthetic showed a very small mesh exposure area at the very top of the vault.2.The vagina is extremely atrophic.3.Vaginal compartments are very well supported.4.The exposed mesh was removed and sent to pathology 5.The fascia had been closed.6.Cystoscopy and an intravesical injection of botox were performed.The standard procedure was a 30-degree cystoscopy and an intravenous injection of 100iu sparing the trigone area.

• 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: 11164595
• MDR Text Key: 226647638
• Report Number: 3005099803-2021-00052
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• 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; Other
• Patient Age: 58 YR
• Patient Sex: Female