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

Catalog Number 72403656

Device Problem Extrusion (2934)

Patient Problems Adhesion(s) (1695); Death (1802); Fistula (1862); Hypoxia (1918); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Urinary Frequency (2275); Sleep Dysfunction (2517); Hematuria (2558); Blood Loss (2597)

Event Date 12/17/2003

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, extrusion, bladder pain, recurrent urinary tract infection, infection, bowel problems, dyspareunia, and vaginal scarring.It was also reported that the plaintiff experienced suprapubic and vaginal pain, vaginal discharge, recurrent bladder stone, stress and urge incontinence, urinary frequency, adhesions, nocturia, vaginal fistula, retention of urine, intrinsic sphincter deficiency, vaginal stenosis, atrophic introitus, vaginal bleeding and gross hematuria.The plaintiff underwent a series of revision surgeries.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as acute respiratory distress failure, hypoxia, pulmonary hypertension and chronic obstructive pulmonary disease.Related to manufacturer report #: 3011770902-2016-00331, 3011770902-2016-00332.

• 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: 5823250
• MDR Text Key: 50478762
• Report Number: 3011770902-2016-00333
• 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: 01/07/2015

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
• Device Expiration Date: 12/03/2003
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2003
• 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
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 65