MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Incontinence (1928); Internal Organ Perforation (1987); Scarring (2061); Septic Shock (2068); Respiratory Failure (2484)

Event Date 08/09/2012

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated december 23, 2014 under exemption (b)(4).Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced worsening of stress incontinence, scarring and bladder perforation.It was also reported that the plaintiff underwent a removal surgery.The device was completely explanted.Furthermore, it was reported that the plaintiff died.The cause of death reported was cardiac arrest, respiratory failure and septic shock.Related to manufacturer report #: 2183959-2014-73096, related to manufacturer report #: 2183959-2014-73079.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 5055806
• MDR Text Key: 24988095
• Report Number: 2183959-2014-73078
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2014
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• 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
• Treatment: ELEVATE POSTERIOR
• Patient Outcome(s): Death
• Patient Age: 66 YR