MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Device Problems Material Separation (1562); Malposition of Device (2616); Folded (2630)

Patient Problem Incontinence (1928)

Event Type  Injury  

Event Description

It was reported that the patient was originally implanted with an elevate anterior graft in (b)(6) 2013.Immediately following the implant surgery, the patient experienced incontinence.The patient was referred to a uro-gynaecologist 10 days post operatively who performed surgery on an unknown date.During the surgery, the elevate anterior graft appeared bunched, torn in many small pieces, attached to the patient's bladder wall, and anteriorly was providing minimal vaginal wall support.The original graft arms were left in-situ and the rest of the graft was removed.A new elevate anterior was suture tied to the existing mesh arms and attached to the sacrospinous ligaments.Another continence sling was also implanted during the surgery to help manage the incontinence symptoms.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Device analysis: eight pieces of the graft mesh were returned embedded in tissue.The longest piece is approximately 3 cm long while most of the pieces are less than 1 cm in length.The edges of the mesh pieces appear both torn and cut.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• 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: 4320907
• MDR Text Key: 5132318
• Report Number: 2183959-2014-00550
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: ELEVATE POSTERIOR
• Patient Outcome(s): Hospitalization; Required Intervention