MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS PERIGEE SYSTEM; SURGICAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Death (1802); Incontinence (1928); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Dysuria (2684); Multiple Organ Failure (3261)

Event Date 07/31/2008

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 allegedly experienced extreme pain, erosion, infection, organ perforation, recurrence, dyspareunia, neuromuscular problems and vaginal scarring.It was also reported that the plaintiff experienced dysuria, frequency urinary tract infections, frequency, hematuria, nocturia, urethral discharge, vaginal wall pain, pelvic pain, cystocele and enterocele.The plaintiff underwent a mesh revision.The device was fully explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as multisystem organ failure, acute hepatic failure and chronic hepatic failure.Related to manufacturer report #: 3011770902-2016-00259, 3011770902-2016-00257, 3011770902-2016-00256.

• Brand Name: AMS PERIGEE SYSTEM
• Type of Device: SURGICAL MESH
• 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: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5670792
• MDR Text Key: 45640640
• Report Number: 3011770902-2016-00258
• Device Sequence Number: 1
• Product Code: OTP
• 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: 11/01/2010

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Weight: 54