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 Problem Malposition of Device (2616)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 12/29/2010

Event Type  malfunction  

Event Description

It was reported that following the implantation of an elevate anterior, the patient had her graft removed during the surgery as it did not hold tension.A second elevate anterior was opened and placed.It was also reported that the patient experienced pain and pudendal nerve damage.If additional information is received, a follow up report will be sent.Related to manufacturer report #: 3011770902-2016-00289.

• 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 LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer Contact: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5772918
• MDR Text Key: 48880093
• Report Number: 3011770902-2016-00290
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2013
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• 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: ELEVATE ANTERIOR
• Patient Outcome(s): Required Intervention