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

Model Number HEWROOT0034

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

The review of the device history records, performed by our quality assurance supervisor, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

Event Description

During a tiron-david vascular surgery performed for aortic dissection, suture hole bleeding started after declamping the aorta.The staff tried to stop the bleeding, and after the patient was transferred in intensive care unit.It was reported that the patient died in icu due to hemorrhage.The graft remained implanted.No information regarding the dates of implantation and patient death is available at the date of this report.

• Brand Name: CARDIOROOT
• 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: 5719796
• MDR Text Key: 47202148
• Report Number: 1640201-2016-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013938
• UDI-Public: 00384401013938
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2019
• Device Model Number: HEWROOT0034
• Device Catalogue Number: HEWROOT0034
• Device Lot Number: 14L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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
• Treatment: ANTIBIOTICS
• Patient Outcome(s): Death
• Patient Age: 45 YR
• Patient Weight: 50