MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403831

Device Problem Extrusion (2934)

Patient Problems Atherosclerosis (1728); Death (1802); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Prolapse (2475)

Event Date 01/03/2013

Event Type  Death  

Manufacturer Narrative

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 experienced recurrent stress urinary incontinence, mesh exposure, recurrent cystocele, and mass in introitus.The plaintiff underwent mesh revision and the device was completely explanted.Furthermore, it was reported that the plaintiff died.The cause of death reported was hypertensive atherosclerotic cardiovascular disease.Related to mfr # 2183959-2015-00587.

Manufacturer Narrative

Corrected data.

• Brand Name: AMS MONARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5298949
• MDR Text Key: 33550464
• Report Number: 2183959-2015-00586
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 02/28/2014
• Device Catalogue Number: 72403831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• 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: 67 YR