MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720093-01

Device Problems Extrusion (2934); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 01/31/2016

Event Type  Injury  

Event Description

It was reported that following the implantation of an elevate anterior, the patient experienced de-novo dyspareunia.It was also reported that the left anchor "pulled out" and exposed the mesh in the anterior vagina.It was noted that the patient's partner experienced pain during intercourse.The patient had the mesh trimmed, in an in office procedure, on (b)(6) 2016.The event was considered resolved/recovered with no sequelae on (b)(6) 2016.There were no further patient complications reported in relation to this event.Related to mfr # 3011770902-2016-00056.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5413359
• MDR Text Key: 37559496
• Report Number: 3011770902-2016-00055
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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
• Treatment: MONARC
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR