MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD SURGICAL MESH

Model Number 2S PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Respiratory Failure (2484)

Event Type  Death  

Manufacturer Narrative

The cause of death was reported as respiratory failure. There is no suspected association between the death and the use of the product. A manufacturing review was performed and found no evidence of a manufacturing related cause for the event. Device not returned to the manufacturer.

Event Description

It was reported that a male patient passed away following an emergency ventral hernia repair surgery performed on (b)(6) 2016. Prior to surgery on (b)(6) 2016, the physician performed a component separation which was unsuccessful in achieving primary closure. The defect was not repaired at that time and the patient was placed in the icu. Ovitex 2s permanent reinforced bioscaffold was used to bridge the defect in the ventral hernia repair surgery performed on (b)(6) 2016; there were no reported complications encountered during the surgical procedure. One week post-op, (b)(6) 2016, the physician's assistant reported that the patient was "doing well. The incision is healing and he is slowly recovering. " the patient passed away sometime between (b)(6) 2016; the exact date of death is unknown. The cause of death was reported as respiratory failure. There is no suspected association between the death and the use of the product.

• Brand Name: OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• Manufacturer Contact: yasmin rai ; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022 ; 498693035
• MDR Report Key: 5995600
• MDR Text Key: 56341409
• Report Number: 3007321028-2016-00001
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: 2S PERMANENT
• Device Catalogue Number: SEE ATTACHED FILE
• Device Lot Number: SEE ATTACHED FILE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/03/2016 Patient Sequence Number: 1