MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; 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 Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests, including a 100% visual inspection.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 blots on the graft's surface.
Event or Problem Description
See mfr initial report for complaint reference (b)(4).
Additional Manufacturer Narrative
(10/213) the involved product was returned to intervascular and was inspected by our quality assurance (qa) supervisor for an evaluation of the device.His observations are as follows: "the product arrived in its box but damaged.The external and internal lids were not open.There is a match between the product, the labelling of the box and the patient set.[.] ¿ the product does not have any apparent excess collagen defect type "internal and external collagen excess" corresponding to pqsd1050 ¿(list of standards for acceptation and rejection).The qa manager also reviewed the case and concluded that the product is not defective.(67) the conducted investigation indicated that the product was not defective.

• Brand Name: INTERGARD WOVEN
• 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: 9107001
• Report Number: 1640201-2019-00049
• Device Sequence Number: 13898923
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: No Information
• 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: 10/21/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1