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

Model Number HEWAA3010080810/1

Device Problem Product Quality Problem (1506)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

(4109/213) the review of historical data indicated that one other complaint for unusual color of product was reported for the same lot number 17a26.However, this other complaint was for a different product type (silver patch, product coated differently) and the unusual color reported was described as a depigmentation (absence of color).Therefore, there is no similar complaint as (b)(4) on the sterilization lot 17a26.(3331/213) the device history records review concluded that there was no nonconformance / planned deviation in relation with the event reported.(10/3233) product has been returned to the manufacturer.Visual inspection is pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

The hospital found some yellow blots on the surface of graft and inner package.Therefore, the hospital returned the product to the distributor.This product was initially sent to hospital around one year ago.There was no delayed surgery due to this event.The hospital used another graft instead.The complaint has been logged under number (b)(4).

Event Description

See initial mfg report #: 1640201-2021-00022.Complaint # (b)(4).

Manufacturer Narrative

Corrected data : in block h6, codes 10/193 were selected.Following the closure of the non-conformity report, it should be 10/111 instead.(10/111) during the inspection of the product, it was pointed out that on the inner lid several yellowish/orange spots and that root cause was unclear and could be related to inappropriate storage conditions by logistic actors.However the non-conformity report 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.Additional manufacturer narrative: (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 #: 1640201-2021-00022.Complaint # (b)(4).

Manufacturer Narrative

One retention sample from another lot was selected as representative of the packaging type.However, this retention sample is expired; indeed, there was no other retention sample with the same packaging model available for manufacturing period.A visual inspection have been performed by the qa department for information only.Please note that the result of the visual inspection is not usable as the retention product is 17 months expired.(10/193) the defective product was visually inspected by the qa supervisor on (b)(6) 2021.Results are as follows: ¿it appears on the inner lid several yellowish/orange spots but the appearance of the outer lid and the box is normal, no visible spots of color or other on the graft." ¿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 and that root cause is unclear and could be related to inappropriate storage conditions by logistic actors.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.An internal non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.

• 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: 12141839
• MDR Text Key: 261059404
• Report Number: 1640201-2021-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010760
• UDI-Public: (01)00384401010760
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: HEWAA3010080810/1
• Device Catalogue Number: HEWAA3010080810/1
• Device Lot Number: 17A26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1