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

Model Number HEWROOT0034

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4): a review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to established procedures and no anomaly was found.Specifically, the review of the mechanical test results obtained on the same fabric as the complaint device indicated values within product specifications.(b)(4): no conclusion can be drawn.However, the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.(b)(4): please note that precautions when cutting the graft are clearly mentioned in the warning section of the instructions for use "due to their intrinsic weaving pattern, woven grafts are more prone to fraying when cut with scissors.As with all woven products, a low-temperature disposable cautery should be used to minimize fraying when cutting this graft".Therefore, it is considered as probable that an user error has contributed to this event.

Event Description

The hospital reported that during a cardioroot graft procedure, surgeon experienced some graft fraying at the point where he used scissors to trim the graft for length.No negative patient outcome was reported.The graft was implanted.

• Brand Name: CARDIOROOT WOVEN
• 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 athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6493157
• MDR Text Key: 72804132
• Report Number: 1640201-2017-00007
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013938
• UDI-Public: 00384401013938
• 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,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2017

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
• Device Operator: No Information
• Device Expiration Date: 08/31/2019
• Device Model Number: HEWROOT0034
• Device Catalogue Number: HEWROOT0034
• Device Lot Number: 14J11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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