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

Model Number 850-200

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994)

Event Date 01/05/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage system was implanted during a transvaginal taping procedure performed on (b)(6) 2009 for the treatment of stress incontinence type three and hypersensitive urethra.The procedure was completed without complications and the patient was taken to the postoperative recovery room in stable condition for postoperative voiding trial prior to discharge.On (b)(6) 2017, the patient underwent a removal of mesh and transvaginal tape laparoscopic procedure due to pelvic pain from her left arm transvaginal tape.A piece of mesh was identified in the left lower quadrant area pushing through; however, not perforating the anterior peritoneum, inferior and medial to the inferior epigastric vessels.Using the harmonic ace the of retzius was opened and the tangle of mesh was identified along the left side wall.The medial border of the mesh was identified and after careful dissection, the entire piece of mesh was dissected and removed.The patient tolerated the procedure well and was awakened and taken to post-anesthesia care unit in stable condition.

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2017 was chosen as a best estimate based on the date of the removal surgery.Initial reporter: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6) the explanting surgeon is dr.(b)(6) (b)(4).

• Brand Name: ADVANTAGE 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: 15952668
• MDR Text Key: 305193668
• Report Number: 3005099803-2022-07024
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729719564
• UDI-Public: 08714729470274
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: 850-200
• Device Catalogue Number: 850-200
• Device Lot Number: 0ML9081701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2009
• 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; Other
• Patient Age: 49 YR
• Patient Sex: Female