MAUDE Adverse Event Report: TELA BIO, INC. OVITEX1S ABSORBABLE MESH; MESH, SURGICAL

Device Problems Entrapment of Device (1212); Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Scar Tissue (2060); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2020

Event Type  Injury  

Event Description

Hiatal hernia surgery using ovitex 1s mesh, along with a tif procedure, (b)(6) 2020.When the time to eat solid food came, i was not able to swallow food.For 10 months had to eat soft or mainly liquids.The surgeon found mesh and sutures embedded inside my esophagus in (b)(6) 2020 during a fourth egd to dilate my esophagus.It was surgically removed, but still had problems swallowing.Had 4 tif fasteners removed (b)(6) 2021.Had barium swallow (b)(6) 2021 which showed no change in the ability to swallow food.I've had 2 surgeons report that the mesh has damaged my esophagus, and i need an esophagectomy.And one surgeon who says that i need to robotically have scar tissue removed and a toupet to completely reverse the tif procedure.This was absorbable mesh and silk sutures.I've had many tests and a total of 8 doctors trying to rectify this situation.The mesh is still inside of me as it is absorbable.Two different surgeons have found silk sutures inside my esophagus, one (b)(6) 2020, another (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: OVITEX1S ABSORBABLE MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TELA BIO, INC.
• MDR Report Key: 15043780
• MDR Text Key: 296171991
• Report Number: MW5110924
• Device Sequence Number: 1
• Product Code: FTM
• 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: 07/14/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2022
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; CENTRUM SILVER ; LEVOTHYROXINE; LISINOPRIL ; METOPROLOL ; NORTRIPTYLINE ; PANTOPRAZOLE; ROSUVASTATIN ; VITAMIN D
• Patient Outcome(s): Life Threatening; Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White