MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ADVANCE XP SLING SYSTEM; SURGICAL MESH

Catalog Number 720163-01

Device Problem Malposition of Device (2616)

Patient Problem Erosion (1750)

Event Type  Injury  

Event Description

It was reported that following the implantation of an advance xp sling, the patient experienced "erosion of the urethra due to extra tension of the sling".The sling was removed and then another continence device was implanted on (b)(6) 2016.No further patient complications were reported in relation with this event.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath MN ; EI
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 6700120
• MDR Text Key: 79569445
• Report Number: 2183959-2017-00061
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2015
• Device Catalogue Number: 720163-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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): Hospitalization; Required Intervention