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

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Emotional Changes (1831); Micturition Urgency (1871); Hemorrhage, Subarachnoid (1893); Incontinence (1928); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Hydrocephalus (3272)

Event Date 08/13/2007

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 allegedly experienced emotional distress and a product problem.It was also reported that the plaintiff experienced urinary retention, urgency, nocturia, fecal incontinence, dysuria, urinary tract infection, recurrent cystocele and malpositioned sling.The plaintiff underwent a revision surgery.The mesh was partially explanted.Furthermore, it was reported that the plaintiff died.The cause of death was reported as acute hydrocephalus and subarachnoid hemorrhage.Related to manufacturer report #: 3011770902-2016-00287 and 3011770902-2016-00288.

• Brand Name: AMS APOGEE 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5755759
• MDR Text Key: 48352905
• Report Number: 3011770902-2016-00286
• 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: 02/13/2013

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 06/28/2016
• 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: SPARC
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 59