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

Catalog Number 72403656

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Death (1802); Dementia (1808); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Irritation (1941); Internal Organ Perforation (1987); Pain (1994); Pneumonia (2011); Scarring (2061); Sepsis (2067); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); Sleep Dysfunction (2517); Blood Loss (2597); Dysuria (2684)

Event Date 02/10/2014

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced recurrence of mixed urinary incontinence and vaginal vault prolapse, cystocele, rectocele, hypermobile urethra, failed mesh, urinary hesitancy, incomplete bladder emptying, vaginal atrophy, bladder and suprapubic pain, dysuria, urgency, frequency, nocturia, vulvar irritation, vaginal discharge and pyuria.It was also reported that the plaintiff allegedly experienced infection, organ perforation, bleeding, dyspareunia and vaginal scarring.The plaintiff underwent revision and the device was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as sepsis, aspiration pneumonia and dementia.Related to manufacturer report #: 3011770902-2016-00361.

• Brand Name: AMS SPARC 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: 5910760
• MDR Text Key: 53384753
• Report Number: 3011770902-2016-00362
• Device Sequence Number: 1
• Product Code: OTN
• 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: 07/15/2013

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: 06/14/2008
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2007
• 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: APOGEE
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 66