MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS APOGEE SYSTEM; SURGICAL MESH

Catalog Number 720002-01

Device Problems Extrusion (2934); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It was reported that the patient had an apogee graft implanted previously and the graft has extruded through the vaginal mucosa on the posterior side.It was indicated that this appears to be a "long-running issue." the patient originally was evaluated in (b)(6) 2011 complaining of increasing pelvic pain on left posterior side.At that time she was referred to physical therapy and also a specialist who recommended surgery and noted "banding on left side." the patient preferred not to undergo surgery.In (b)(6) 2014, the patient was evaluated by the physician who implanted her apogee.The patient reported pain "primarily on right side." the patient will undergo a revision surgery on (b)(6) 2014 to remove 5x10mm piece of mesh.No additional patient complications have been reported in relation to this event.

Event Description

Additional information received indicated that a revision surgery occurred on (b)(6) 2014.The physician did not take out the entire graft.He cut the apogee arms on the left and right sides of the graft where patient reported pain (especially on the right side) and surgeon had felt banding prior to surgery.No banding was felt by surgeon on either side proximally after he cut the arms.In addition, he cut out extruded part of the graft, which was in the graft's mid-section.The amount of mesh cut out was estimated by the surgeon to be 1 1/2 cm by 4 cm.Premarin cream was used post operatively.Patient will come in for a post-op visit in 2 weeks.No additional patient complications have been reported in relation to this event.

• Brand Name: AMS APOGEE SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3907253
• MDR Text Key: 4488232
• Report Number: 2183959-2014-00262
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2011
• Device Catalogue Number: 720002-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2008
• 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
• Patient Outcome(s): Hospitalization; Required Intervention