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 Erosion (1750); Death (1802); Emotional Changes (1831); Pain (1994); Scarring (2061); Thyroid Problems (2102); Urinary Retention (2119); Urinary Tract Infection (2120); Chronic Obstructive Pulmonary Disease (COPD) (2237); Disability (2371); Obstruction/Occlusion (2422); Respiratory Failure (2484); Dysuria (2684); Fibrosis (3167)

Event Date 03/01/2011

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, voiding difficulties and erosion.It was reported that in (b)(6) 2011, the plaintiff noted obstructive urinary symptoms with high post void residuals.The plaintiff underwent a revision surgery and the mesh was excised.The plaintiff also allegedly experienced recurrence of symptoms scarring and will continue to suffer, have pain, disability, impairment and loss of enjoyment of life, the inability to engage in chosen and necessary activities and other damages.Furthermore, it was reported that the plaintiff died.The causes of death were reported as acute respiratory failure, chronic obstructive pulmonary disease and pulmonary fibrosis secondary to hypothyroidism and urinary tract infections.Related to mfr # 3011770902-2016-00087.

• 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: 5454472
• MDR Text Key: 38810265
• Report Number: 3011770902-2016-00088
• 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: 06/27/2012

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: 08/02/2013
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2010
• 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
• Treatment: MINIARC
• Patient Outcome(s): Death
• Patient Age: 84 YR