MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720046-01

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Erosion (1750); Congestive Heart Failure (1783); Death (1802); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Itching Sensation (1943); Pain (1994); Thyroid Problems (2102); Burning Sensation (2146); Chronic Obstructive Pulmonary Disease (COPD) (2237); Urinary Frequency (2275); Injury (2348); Blood Loss (2597)

Event Date 03/27/2013

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 08/30/2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, urinary problems, bowel problems, bleeding, emotional distress, other unspecified injuries and a product problem.It was also reported that the plaintiff experienced atrophy, vaginal mesh erosion, vaginal itch or burning, pelvic pain, urine leakage, urinary urgency and frequency, dullness in pelvic area, voiding dysfunction and mild vaginal pressure sensation.The plaintiff underwent a revision.The mesh was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as chronic obstructive pulmonary disease, congestive heart failure, oxygen dependent, atrial fibrillation, chronic kidney disease, mellitus and hypothyroidism.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 5812503
• MDR Text Key: 50117816
• Report Number: 3011770902-2016-00318
• Device Sequence Number: 1
• Product Code: PAH
• 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: 03/13/2013

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: 08/26/2012
• Device Catalogue Number: 720046-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2009
• 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
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 100