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

Catalog Number 72403830

Device Problem Extrusion (2934)

Patient Problems Adhesion(s) (1695); Erosion (1750); Death (1802); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scarring (2061); Blood Loss (2597); Cancer (3262)

Event Date 11/24/2010

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, infection, vaginal scarring, urinary problems, adhesions, recurrence, emotional distress and a product problem.It was also reported that the plaintiff experienced apical mesh erosion, extruded vaginal mesh, and bleeding.The plaintiff underwent a series of revision surgeries.The device was completely explanted.Furthermore, it was reported that the plaintiff died.The cause of death was reported as metastatic small cell cancer.

• Brand Name: AMS MONARC 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: 5906633
• MDR Text Key: 53090801
• Report Number: 3011770902-2016-00353
• Device Sequence Number: 1
• Product Code: OTN
• 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: 07/01/2014

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: 09/24/2008
• Device Catalogue Number: 72403830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2007
• 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: GYNECARE
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 103