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

Catalog Number 720046-01

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cardiac Arrest (1762); Death (1802); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360)

Event Date 08/16/2010

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 6/30/2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain and suffering, mental anguish, emotional distress, disfigurement, physical impairment, embarrassment and humiliation, psychological injury, a reasonable and traumatic fear of an increased risk of additional injuries, progression of existing conditions and other serious injury, loss and a product problem.It was also reported that the plaintiff experienced persistent irritative voiding symptoms and penetration of sling mesh into the bladder lumen.The plaintiff underwent a revision surgery.The mesh was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as cardiac arrest, coronary artery disease and hypertension.

• Brand Name: AMS MINIARC 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: 5782617
• MDR Text Key: 49178588
• Report Number: 3011770902-2016-00292
• 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: 10/10/2013

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: 08/11/2012
• Device Catalogue Number: 720046-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2009
• 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: 55 YR