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

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Chronic Obstructive Pulmonary Disease (COPD) (2237); Injury (2348); Respiratory Failure (2484); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced an unspecified injury.The device remains implanted.Furthermore, it was reported that the plaintiff died.The causes of death were chronic obstructive pulmonary disease, cardiopulmonary arrest, respiratory failure and lung cancer.Related to manufacturer report #: 3011770902-2016-00308.

• Brand Name: AMS ELEVATE POSTERIOR 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5804825
• MDR Text Key: 49879759
• Report Number: 3011770902-2016-00307
• 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: 08/24/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: INTEXEN
• Patient Outcome(s): Death