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

Catalog Number 720191-01

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Edema (1820); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Irritation (1941); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684)

Event Date 12/14/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Total number of events summarized - 269.Ams miniarc precise single-incision sling system - 94.Ams miniarc sling system - 175.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced mixed incontinence, hematuria, mild chronic cystitis, urethral stricture, urinary retention, frequency, nocturia, vaginal irritation, urgency, suprapubic and rectal pain, lower abdomen and lower back pain, urinary tract infections, urethral erosion, ureteral obstruction, scarring, edema around the mesh material, extrusion, overactive bladder, decreased detrusor contractility, vaginal dryness, urinary tract infection, intrinsic sphincter deficiency, atonic or neurogenic bladder, dysuria, and low bladder capacity.The device was partially explanted.No further complications have been reported in relation to this event.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION 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: 5856539
• MDR Text Key: 51474049
• Report Number: 3011770902-2016-12496
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/09/2016

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: 09/29/2011
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2010
• 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: SPARC SLING SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 78 YR
• Patient Weight: 76