MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. ELEVATE/AMS TRANSVAGINAL MESH IMPLANT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Device Problem Migration (4003)

Patient Problems Erosion (1750); Failure of Implant (1924); Pain (1994); Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Elevate/ams transvaginal mesh device (b)(6) 2010 elevate/ams transvaginal mesh implanted.In (b)(6) 2022 pelvic pain, vaginal piercing sensation (b)(6) 2022 pcp visit, referred to gynecologist (b)(6); (b)(6) 2022 biopsy confirmed mesh erosion (b)(6) 2022 (b)(6) diagnosis mesh erosion with possible migration -surgery scheduled for (b)(6) 2022; 2010 operative notes, (b)(6) 2022 biopsy report, (b)(6) 2022 (b)(6) evaluation all available as pdf.Surgery required to cease further perforation/erosion/migration.Surgery scheduled 8/11/2022.Fda safety report id# (b)(4).

• Brand Name: ELEVATE/AMS TRANSVAGINAL MESH IMPLANT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 14633117
• MDR Text Key: 293693890
• Report Number: MW5110190
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/04/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2022
• Patient Sequence Number: 1
• Treatment: EZETIMIBE 10 MG PM; AREDS 2; ASPIRIN 81 MG/PM; CARVEDILOL 12.5 MG AM/PM; ESCITALOPRAM 5 MG PM ; ESTRACE CREAM 4/WK/PM ; FUROSEMIDE 20 MG AM ; HUMALOG 100 MG ; INSULIN PUMP ; LOSARTAN 50 MG AM ; MULTIVITAMIN ; PANTOPRAZOLE 40 MG AM/PM ; PRUE'S RXS ; RX: #0637166-15674 LEVOTHYROXINE .025 MCG AM ; SIMVASTATIN 40 MG PM; SPIRONOLACTONE 25 MG AM
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White