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

Model Number	INTERGARD WOVEN AORTIC ARCH
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(3331/213) 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.These tests include a 100% inner diameter measurement based on the international iso (b)(4) standard for vascular grafts.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(10/213) a fragment of the involved product was returned to intervascular and was inspected by the quality assurance (qa) manager.His observations are as follows: "the sample was packaged in a pill box.The measurement of the sample diameter of the product body was performed with the qa measurement set no.1 mes 12-078 the result was: 26.8mm for a specification of 26mm +/- 1mm.From a diameter perspective, the transmitted sample conforms to the specification." (67) the conducted investigation suggests that the product was not defective.
Event or Problem Description
According to the surgeon, the diameter of the prosthesis is not the one indicated on the packaging.It was later confirmed that the graft was implanted.The surgeon cut a piece of the graft and sent it to us for evaluation.

• Brand Name: STANDARD
• 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: 8873275
• Report Number: 1640201-2019-00037
• Device Sequence Number: 16791164
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: 00384401010746
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: 10/31/2023
• Device Model Number: INTERGARD WOVEN AORTIC ARCH
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 18L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1