MAUDE Adverse Event Report: INTERVASCULAR SAS CARDIOROOT; VASCULAR POLYESTER GRAFT

Model Number	HEWROOT0026
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records, indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests including a 100 % visual inspection.No anomaly was found.A visual inspection of the complaint device was performed by our quality assurance manager.The returned product was impregnated by an uncolored and odorless liquid.On the inner side, at one end of the graft, yellow substance and light yellow areas can be observed.This phenomenon corresponds to a collagen peel-off.The other end and the external side of the graft do not present any abnormality.No conclusion can be drown.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacturing.However, the product, as it was received, does not conform to the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.
Event or Problem Description
The hospital reported that during an ascending aorta dissection procedure, a cardioroot graft was being implanted and had to be removed because of a yellow substance on the interior part of the graft.No patient effect was reported.

• Brand Name: CARDIOROOT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6618110
• Report Number: 1640201-2017-00017
• Device Sequence Number: 13572002
• Product Code: DSY
• UDI-Device Identifier: 00384401013891
• UDI-Public: 00384401013891
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• 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
• Report Date (Section B): 06/07/2017

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: 01/31/2021
• Device Model Number: HEWROOT0026
• Device Catalogue Number: HEWROOT0026
• Device Lot Number: 16B25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1