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); Incontinence (1928); Pain (1994); Scarring (2061); Ulceration (2116); Discomfort (2330); Prolapse (2475); Blood Loss (2597); Fibrosis (3167)

Event Date 11/16/2010

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and product problem.It was also reported that the plaintiff experienced worsening stress urinary incontinence, mesh exposure, fibrosis and rectocele.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00260.

Event Description

Additional information received indicated that the plaintiff experienced enterocele, vaginal vault prolapse, irritable bladder, diffuse ulcerations, pain, severe discomfort and scarring.It was also reported that the plaintiff allegedly experienced erosion, bleeding and bowel problems.

• 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: 5670789
• MDR Text Key: 45645092
• Report Number: 3011770902-2016-00261
• 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: 05/16/2016

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: 05/26/2011
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2010
• 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
• Patient Outcome(s): Death
• Patient Age: 79 YR