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

Model Number	HEWROOT0034
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Blood Loss (2597)
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5719796
• Report Number: 1640201-2016-00015
• Device Sequence Number: 10804541
• Product Code: DSY
• UDI-Device Identifier: 00384401013938
• UDI-Public: 00384401013938
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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: 10/31/2019
• Device Model Number: HEWROOT0034
• Device Catalogue Number: HEWROOT0034
• Device Lot Number: 14L20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2016
• Initial Report FDA Received Date: 06/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTICS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 45 YR
• Patient Weight: 50