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

Model Number HEWAA2610080810/1

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the product is available for investigation; it is in the process of being returned to intervascular for examination.The device history records review is in progress, conclusion is pending.The review of historical data indicated that one other similar complaint, for yellow stains on the inner lid, was reported for the same type of product and same sterilization lot number.For this older complaint, the conducted investigation suggested that the device was not defective at the time of manufacturing.However, the product, as it was returned to the manufacturer, was confirmed as not conform to the specification.The root cause was unclear but probably related to inappropriate storage conditions by logistical actors.Please note that, according to manufacturing records of both involved products, coating was not performed the same day for both products, and the coating dispersions used were different.One retention sample from another lot was selected, based on the type of product and the coating date.A visual inspection by the qa department will be performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

The physicians found the outer box worn and there are yellowish stains on the inner layer of the cover of tray.The product package does not meet the hospital¿s requirements.The issue was found during inspection, before surgery.The product has not been used on a patient.

Event Description

See initial mfr report #: 1640201-2021-00020.Complaint # (b)(4).

Manufacturer Narrative

(3331/213) the device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.(4102/213) the selected retention sample was inspected by the qa supervisor.His conclusions are as follows:"the inspection of the retention product including the control of the packaging components has been completed.We can confirm that on the inner and outer primary packaging components no stain/halo is apparent that would be related to complaint # (b)(4).This retention sample is compliant from a product/packaging perspective." (10/3233) the defective product has been received by intervascular.The examination is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/111) the involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.The result are as follows: "there are several yellowish/orange stains on the inner lid, but the outer lid and the box look normal, with no visible stains of color or otherwise on the product." "the products, being non-conforming and coming from a customer, are physically rejected.¿ the product is not compliant with our list of standards for acceptation and rejection for packaging.Following the visual inspection a non conformity report has been initiated in order to identify the root cause.It concludes that root cause could be related to packaging design inducing a prolonged contact between product and tyvek lid resulting in glycerol stains on the lid.Please not that glycerol is an integral part of the product.(67) the outcome of the investigation which included all available information and the inspection performed on the returned product would tend to indicate that the issue was related to packaging design inducing a prolonged contact between product and internal tyvek lid resulting in glycerol stains on the lid.However, the observed glycerol traces are not an unusual phenomenon and do not affect the product quality and performance and constitutes a cosmetic defect.

Event Description

See initial mfg report #: 1640201-2021-00020.Complaint # (b)(4).

• 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
• MDR Report Key: 12016244
• MDR Text Key: 256797248
• Report Number: 1640201-2021-00020
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: (01)00384401010746
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: HEWAA2610080810/1
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 17J21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 07/22/2021
• Patient Sequence Number: 1