MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720093-01

Device Problem Disconnection (1171)

Patient Problems Pulmonary Embolism (1498); Cardiopulmonary Arrest (1765); Death (1802); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Urinary Retention (2119); Injury (2348); Prolapse (2475)

Event Date 07/05/2010

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 12/31/2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain and suffering, mental anguish, emotional distress, disfigurement, physical impairment, psychological injury, embarrassment and humiliation, progression of existing conditions and a product problem.The plaintiff also experienced anterior components of the mesh pull out from the obturator muscle resulting in a recurrence, enterocele, cystocele, incomplete bladder emptying and some mild perivaginal defects.Furthermore, it was reported that the plaintiff died.The causes of death were reported as cardiopulmonary arrest, pulmonary embolism and hypertension.Related to mfr #2183959-2015-00576.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• 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: 5286190
• MDR Text Key: 33183681
• Report Number: 2183959-2015-00571
• Device Sequence Number: 1
• Product Code: OTP
• 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: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2012
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2009
• 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: SPARC
• Patient Outcome(s): Death
• Patient Age: 57 YR