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

Model Number	HEWAA3010080810/1
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
Device is not accessible for testing.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.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.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 or Problem Description
When the doctor open the package of this graft, there were several unknown yellow blots on the graft's surface.
Additional Manufacturer Narrative
(11/213) one retention sample from same sterilization lot coated on the same day and under the same conditions as the involved device was visually inspected.Here are the qa supervisor observations : " on the retention prosthesis, the visual inspection was performed this morning by a qc2 technician.No defect was found according to the (b)(4) list, neither in connection with the complaint"((b)(4) is the list of acceptance /rejection criteria) (67) no conclusion can be drawn since the involved product was not returned.However the conducted investigation suggests that the product was not defective at the time of manufacturing.
Event or Problem Description
Complaint reference (b)(4).

• 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: 9105561
• Report Number: 1640201-2019-00050
• Device Sequence Number: 16733845
• Product Code: DSY
• UDI-Device Identifier: 00384401010760
• UDI-Public: 00384401010760
• 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): 11/08/2019

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: 12/31/2020
• Device Model Number: HEWAA3010080810/1
• Device Catalogue Number: HEWAA3010080810/1
• Device Lot Number: 16A07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1