MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403656

Device Problem Insufficient Information (3190)

Patient Problems Atherosclerosis (1728); Death (1802); High Blood Pressure/ Hypertension (1908); Scar Tissue (2060); Prolapse (2475)

Event Date 01/03/2013

Event Type  Death  

Manufacturer Narrative

Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced posterior vaginal wall prolapse, recurrent enterocele, rectocele, and vaginal apical scar.Furthermore, it was reported that the plaintiff died.The cause of death reported were aortic dissection, hypertension, and atherosclerosis.Related to manufacturer report #: 2183959-2015-60254 and related to manufacturer report #: 2183959-2015-60135.

• Brand Name: AMS SPARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 5090662
• MDR Text Key: 26265768
• Report Number: 2183959-2015-60255
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 09/08/2015

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: 04/24/2007
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2006
• 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: UNKNOWN GRAFT
• Patient Outcome(s): Death
• Patient Age: 80 YR