MAUDE Adverse Event Report: AROA BIOSURGERY LTD. RESTELLA; MESH, SURGICAL

Model Number R20253-1018G

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Dhr review: restella resorbable polymer batch ert-9e01 was fabricated on 01 may 2019.The completed batch record was reviewed to assist this investigation.Forty-four devices were manufactured and released for sale.Qc release testing for the final batches were reviewed.All tests were carried out as per established testing procedures, the individual results from the required test were all within aroa's specification.Batch was approved to release based on the completion of correct manufacturing processes and satisfactory results of the quality testing on the final devices.This batch was released for commercial sale from may 2019.There are no other device complaints received from any other customers for this batch.Based on the investigation, there is no evidence showing a suspected association between the patient developing skin necrosis and infection and the use of the device from this restella batch.

Event Description

A patient underwent a unilateral (right) mastectomy, after which a 500cc allergan expander was implanted.Before implantation, the pocket was irrigated with chlorpactin and the skinflap treated with betadyne.Two restella 10x18.5cm resorbable contours were sewn together with 3-0 monocryl and attached to the expander tabs.The expander tabs and some of the restella were attached to the chest wall.A blake drain was placed medially and along the imf and the skin flap closed.The incision was covered with gauze and tegraderm.On (b)(6) 2019 the expander and restella were removed due to dehiscence/exposure.There was noted skin necrosis and infection.

• Brand Name: RESTELLA
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 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: tina obrien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 8984595
• MDR Text Key: 159678034
• Report Number: 3007321028-2019-00014
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421905067058
• UDI-Public: 09421905067058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: R20253-1018G
• Device Lot Number: ERT-9E01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention