MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720191-01

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Injury (2348); Blood Loss (2597)

Event Date 07/02/2011

Event Type  Death  

Manufacturer Narrative

Unknown sling.Implant date: 2009.This was initially reported on the summary report dated 12/23/2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress, recurrence, bleeding, trouble with bowel movements, unspecified injuries and extrusion.The plaintiff experienced urinary tract infection, vaginal infection, mixed incontinence, vaginal atrophy, vaginal pain, mesh erosion, stress urinary incontinence, dyspareunia, urgency, frequency and nocturia.The plaintiff underwent excision of vaginal mesh.Furthermore, it was reported that the plaintiff died.No cause of death was reported.

Event Description

Additional information received indicated that the plaintiff allegedly experienced vaginal discharge and dryness.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5452382
• MDR Text Key: 38744312
• Report Number: 3011770902-2016-00080
• Device Sequence Number: 1
• Product Code: PAH
• 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,Followup
• Report Date: 09/05/2014

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: 04/20/2012
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2011
• 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
• Patient Age: 58 YR
• Patient Weight: 66