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

Model Number	HEWROOT0028
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
((b)(4)) a review of the complaint device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.((b)(4)) 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.(b)(4).
Event or Problem Description
During an aortic repair valve replacement performed on (b)(6) 2015, suture hole bleeding was noticed, which required the use of hemostatic agent.The graft remained implanted.The patient was reported as processing well.

• Brand Name: CARDIOROOT
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5363396
• Report Number: 1640201-2015-00048
• Device Sequence Number: 691187
• Product Code: DSY
• UDI-Device Identifier: 00384401013907
• UDI-Public: 00384401013907
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/17/2015

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: 06/30/2020
• Device Model Number: HEWROOT0028
• Device Catalogue Number: HEWROOT0028
• Device Lot Number: 15G02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2016
• 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