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

Model Number	HEWAA2810080810/1
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that one other similar complaints was reported for the same sterilization lot.The investigation is ongoing.The device history records review concludes that there is no non-conformance/planned deviation in relation with the event reported.It was reported that the product is available for investigation, it should be returned to intervascular for examination.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
When the doctor open the package of this graft, there were several unknown yellow bolts on the surface.(picture provided shows stain on the product surface).
Additional Manufacturer Narrative
4109/213) the review of historical data indicated that one other similar complaint was reported for the same sterilization lot (complaint # (b)(4).For this other similar complaint, the investigation concluded that the product was not defective.So the conclusion of the historical data review is finally that a problem was not found.(10/213) the involved product was returned to intervascular and was inspected by our quality supervisor.Results are as follows : "after visual inspection of the defective product, i can see that there are some stains which are more yellow than others but which are in agreement with our product specifications and therefore acceptable because there is no visible overthickness at these places." (67) the conducted investigation suggests that the product was not defective.
Event or Problem Description
See mfr initial report # 1640201-2019-00084.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
• MDR Report Key: 9336816
• Report Number: 1640201-2019-00084
• Device Sequence Number: 16612496
• Product Code: DSY
• UDI-Device Identifier: 00384401010753
• UDI-Public: 00384401010753
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 02/28/2022
• Device Model Number: HEWAA2810080810/1
• Device Catalogue Number: HEWAA2810080810/1
• Device Lot Number: 17C09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1