MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HEWAA2410080810/1
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20m24.Based on the picture provided by the customer, the product damage was confirmed.It appears to be caused by a bad handling of the product box, which may have occurred during storage/transport.The conducted investigation confirmed that the product was defective when received by the customer, due to an handling issue of the product box, which may have occurred during storage/transport.Therefore, an internal non-conformity report has been initiated in order to investigate the root cause and to take appropriate corrective actions if necessary.Please note the presence of the following mention on the instructions for use: "contents sterile unless package is opened or damaged.Do not use if sterile barrier is damaged.If damage is found, call your local distributor or getinge representative.".
Event or Problem Description
When the customer (distributor) checked the received goods, he found a product box damaged.According to the customer, the shipping box outside was intact.Complaint # (b)(4).

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11715363
• Report Number: 1640201-2021-00009
• Device Sequence Number: 17101967
• Product Code: DSY
• UDI-Device Identifier: 00384401010739
• UDI-Public: 01003844010107391120122417251130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2025
• Device Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 20M24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1