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

Model Number HEWAA2810080810/1

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21b04.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

It was reported: "the cargo is damaged before placing in the warehouse of the airport (b)(6).The amount of damage determined at the warehouse of the recipient." (b)(4).

Event Description

See mfg report #1640201-2021-00039.Complaint #(b)(4).On december 16, 2021 we received additional information that the product could not be returned as it was requested by the hospital.The product was implanted.The patient's status is good.The hospital accepted damaged boxes as its only cardboard and the internal packaging was intact without any traces of damages.

Manufacturer Narrative

Corrected data: on block d9, it was initially stated that the product was available for evaluation.On december 16, 2021 we received the information that the product could not be returned as it was requested by the hospital.On block h6, the health effect ¿ impact codes "2645" was replaced by "2199" as we received the information that the product was implanted and the patient's status is good.(4117) device is not accessible for testing as it was implanted in the patient.The hospital accepted damaged boxes as its only cardboard and the internal packaging was intact without any traces of damages.(4112/3236) a visual inspection based on pictures received was performed by our quality assurance manager.His conclusion is as follows : "based on the attached photo, i do believe that the box was damaged during shipping." "in the photos, several products are clearly non-compliant due to the damaged box, there is a risk of damage to the sterile barrier." (18) please note that, as per the product 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.(4308) 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.H3 other text : 4117 - device implanted.

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• Type of Device: 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 gailard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12923785
• MDR Text Key: 286251280
• Report Number: 1640201-2021-00039
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 003844401010753
• UDI-Public: (01)003844401010753
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Model Number: HEWAA2810080810/1
• Device Catalogue Number: HEWAA2810080810/1
• Device Lot Number: 21G08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose