MAUDE Adverse Event Report: GYRUS ACMI, INC DURAVENT VT TB 1.27MM TP (60/PK); TUBE, TYMPANOSTOMY

Model Number	245775
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at the time of initial procedure to place duravent tube was (b)(6).Patient age at time of device removal procedure was (b)(6).The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported one year, six months and 19 days after a duravent tube was placed during a bilateral myringotomy and tubes (bm-t) procedure, skin healed over the duravent tube requiring a surgical incision to be made to remove the device.Sequence of events as follows: (b)(6) 2019: tube bm-t.A duravent tube was placed.(b)(6) 2021: right inner ear foreign body removal.Duravent tube was surgically removed from inner ear.Procedure completed under anesthesia with microscope.Incision was required as skin healed over the duravent tube.There were no additional consequences to the patient as a result of this occurrence.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause could not be determined as the device was not made available for evaluation, failure can likely be attributed to the incision made for the implant.If the incision was too large, it would cause the flanges of the implant to not be positioned outside of the incision.The large incision would cause the skin to grow over the implant and migrate into the middle ear.Olympus will continue to monitor the field performance of this device.

• Brand Name: DURAVENT VT TB 1.27MM TP (60/PK)
• Common Device Name: TUBE, TYMPANOSTOMY
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11952047
• Report Number: 1037007-2021-00044
• Device Sequence Number: 19103935
• Product Code: ETD
• UDI-Device Identifier: 00821925018143
• UDI-Public: 00821925018143
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 245775
• Device Lot Number: ME823412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR