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 Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831)

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 10/31/2014 (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and a product problem.The mesh remains implanted.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00315.

• 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5808286
• MDR Text Key: 49969137
• Report Number: 3011770902-2016-00314
• 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
• Report Date: 12/31/2013

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: 05/09/2015
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• 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): Death
• Patient Weight: 80