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	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On date of event, the event date was set on (b)(6) 2021, as is was the day the product damaged was received by the customer.The damage to the products occurred between the day of shipment and the day of receipt, which is between (b)(6) 2021.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21k07.As the defects appear obvious on the pictures provided, a visual inspection based on pictures received was performed by our qa supervisor.His conclusion is as follows : " based on the pictures, i confirm that the product in the state is not in conformity.A damage during transportation seems to be the most probable root cause." the most probable root cause of this event is an improper handling of the package during transport.An internal non-conformity report has been initiated in order to take appropriate action.
Event or Problem Description
Article hewaa2410080810 / 1 (b)(4).Packaging arrived damaged, customer wants to return goods.(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
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12880458
• Report Number: 1640201-2021-00036
• Device Sequence Number: 4906758
• Product Code: DSY
• UDI-Device Identifier: 00384401010739
• UDI-Public: (01)00384401010739
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 21K07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown