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

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Erosion (1750); Failure of Implant (1924); Unspecified Infection (1930); Nerve Damage (1979); Scarring (2061)

Event Date 08/22/2007

Event Type  Injury  

Event Description

Related to mfr report number 2183959-2015-00151.It was reported by the patient, that following the implant of her perigee graft for pelvic organ prolapse in 2006, she has "had eight surgeries to address the devices eroding, scarring, and maiming" her.The most recent surgery in 2014, the surgeon "was able to remove 98.9% of the initial mesh, however, the mesh was taken out in 15 pieces." the mesh was "all over" her pelvic floor, "inserted into the muscle and major nerves, both pudendal and obturator nerves are affected" and there was "severe scarring in every space and segment of the pelvic floor." she reported she has "yet to fully heal.The nerve damage may very well be permanent." the patient has been unable to have intercourse due to the "vaginal canal becoming shortened because the device crumbled, bunched up, and corded." there were "also parts of the device coming apart inside" of her.She had a "foreign body reaction, numerous infection, and untold hours, days, years, missing out on daily living." she reported it is now "impossible" to sit and she "cannot get out of bed." there were no further patient complications reported as a result of this event.

Manufacturer Narrative

Implant date: implanted 2006.Explant date: explanted 2014.Concomitant product: therapy date 2006.

• Brand Name: AMS PERIGEE 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: 4690792
• MDR Text Key: 22246470
• Report Number: 2183959-2015-00150
• 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: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• 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
• Date Manufacturer Received: 03/23/2015
• 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 SLING
• Patient Outcome(s): Hospitalization; Required Intervention