MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE; SURGICAL MESH

Catalog Number 72404212

Device Problem Extrusion (2934)

Patient Problems Atherosclerosis (1728); Erosion (1750); Death (1802); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Multiple Organ Failure (3261)

Event Date 09/10/2007

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 08/30/2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced pain in groin, pain in her pubic region, back and hip, yeast infection, stress urinary incontinence, leakage with strong cough, occasional post void dribbling, frequency, urgency, pressure, bladder pain, severe dysuria, postmenopausal atrophic vaginitis, vaginal prolapse, vaginal pain, extrusion, mild cystocele, urinary tract infection.It was also reported that the plaintiff allegedly experienced erosion, infection, urinary problems, bowel problems, neuromuscular problems, vaginal scarring, and also a product problem.The plaintiff underwent a revision surgery.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as multisystem organ failure, bowel infarction and generalized atherosclerosis.Related to manufacturer report #: 3011770902-2016-00359, 3011770902-2016-00360.

• Brand Name: AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
• 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5910582
• MDR Text Key: 53374965
• Report Number: 3011770902-2016-00358
• 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: 08/06/2013

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: 04/30/2008
• Device Catalogue Number: 72404212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2007
• 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: PERIGEE
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 68