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

Model Number	HEWROOT0030
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2017, during a cardiac surgery, the involved graft frayed.The surgeon was creating a bio bentall with the involved graft and a magna heart valve.The surgeon reported that it necessitated stopping twice to deal with the fraying of the graft.According to the surgeon, the patient was quite ill with ejection fraction 25% and the added cardiac ischemic time and cardiopulmonary bypass (cpb) time related to this graft issue was severely suboptimal.In the surgeon's estimation it extended his cardiac ischemic period of his already compromised heart by 10-15 minutes and also his cpb time if the graft had frayed any more.The surgery was completed with the involved graft, and no adverse outcome for the patient was reported.
Additional Manufacturer Narrative
(b)(4) the outcome of the investigation would tend to indicate that the product was not defective at the time of manufacturing (no failure detected).However, due to their intrinsic weaving pattern, woven grafts are prone to fraying.Considering the reported event (frayed graft at the time of use : out of specification), a non-conformance report has been initiated in order to investigate the root cause and take appropriate corrective actions.

• Brand Name: CARDIOROOT AORTIC GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6431450
• Report Number: 1640201-2017-00006
• Device Sequence Number: 16278699
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: 00384401013914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/30/2021
• Device Model Number: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 16G21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention