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 Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Injury (2348); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)

Event Date 01/27/2012

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.(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 during ablation and advantage fit sling procedures performed on (b)(6) 2012 to treat persistent menorrhagia and stress incontinence.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Additional information: blocks a1, a4, b2, b5, section e, and h6: patient codes and impact codes have been updated based on the additional information received on september 8, 2022.Block b3 date of event: date of event was approximated to january 27, 2012, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient codes e2330 and e1405 capture the reportable events of pain and dyspareunia.Impact code f2303 captures non-surgical medication.Block h11: block g2 report source has been corrected.

Event Description

It was reported that an advantage fit system was implanted into the patient during ablation and advantage fit sling procedures performed on january 27, 2012 to treat persistent menorrhagia and stress incontinence.As reported by the patient's attorney, after the implantation, the patient had experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.---additional information received on september 8, 2022--- it was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a removal mirena + hysteroscopy dilatation and curettage + novasure endometrial ablation (non-bsc device) + advantage fit mid-urethral sling procedure performed on january 27, 2012 due to persistent menorrhagia and stress incontinence.After the procedure, the patient experienced complications and received nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; other pain (right leg); painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; psychiatric injury nonsurgical treatments: the patient was treated with pain medication: pentadol, poseen, pandol.The patient was treated with psychological medication: amitriptyline.On (b)(6) 2016 the patient commenced physiotherapy treatment (including pelvic floor exercises or training).

• 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: 11175543
• MDR Text Key: 227061358
• Report Number: 3005099803-2021-00046
• 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: 10/06/2022

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: 09/30/2014
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: ML00000319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2011
• 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): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 120 KG