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

Model Number	HEWAA2810080810/1
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
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, they found the graft is much shorter than usual.
Additional Manufacturer Narrative
(10/213) the involved device was returned to intervascular for examination and was inspected by our quality assurance (qa) supervisor for dimension evaluation.His observations are as follows: "the product arrived on a damaged packaging and with unopened blister lids." "the product is in compliance with dimension specification." (67) the conducted investigation suggests that the product was not defective.
Event or Problem Description
When the doctor open the package of this graft, they found the graft is much shorter than usual.

• 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: 9099015
• Report Number: 1640201-2019-00048
• Device Sequence Number: 16810377
• 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): 10/31/2019

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: 11/30/2023
• Device Model Number: HEWAA2810080810/1
• Device Catalogue Number: HEWAA2810080810/1
• Device Lot Number: 18M20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1