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

Model Number HEWROOT0030

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6431450
• MDR Text Key: 70769796
• Report Number: 1640201-2017-00006
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: 00384401013914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention