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

Model Number UNK13

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

Patient Problems Death (1802); Pain (1994)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 system tension-free vaginal tape (tvt) device was placed in a patient on an unknown date.According to the complainant, on (b)(6) 2017, the patient experienced pelvic pain.It was reported that, subsequently the patient underwent ¿total laparoscopic and vaginal removal of tvt.¿ it was reported that the patient has died.The cause of the patient¿s death, and the relationship (if any) to the device or the procedure have yet to be ascertained.

Event Description

It was reported to boston scientific corporation that an advantage system tension-free vaginal tape (tvt) device was placed in a patient on an unknown date.According to the complainant, on (b)(6) 2017, the patient experienced pelvic pain.It was reported that, subsequently the patient underwent ¿total laparoscopic and vaginal removal of tvt.¿ it was reported that the patient has died.The cause of the patient¿s death, and the relationship (if any) to the device or the procedure have yet to be ascertained.Additional information received from on january 22,2018: the event did not lead to death.

• Brand Name: ADVANTAGE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7179390
• MDR Text Key: 96879119
• Report Number: 3005099803-2017-03945
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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 Model Number: UNK13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Required Intervention