MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Septic Shock (2068); Injury (2348); Multiple Organ Failure (3261)

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 04/07/2016.

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced an unspecified injury.The device remains implanted.Furthermore, it was reported that the plaintiff died.The cause of death reported was septic shock and multi-organ failure.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• 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: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5660298
• MDR Text Key: 45321117
• Report Number: 3011770902-2016-00244
• Device Sequence Number: 1
• Product Code: OTP
• 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
• Report Date: 02/24/2016

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: 09/03/2013
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2010
• 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