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

Model Number	HEWROOT0026
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100 % visual inspection of the graft.Specifically, the review of the collagen coating records evidenced no anomaly.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
The hospital reported that the sealing collagen coat of the vascular graft detached spontaneously from the inner surface.
Additional Manufacturer Narrative
(10/3221) a visual inspection of the complaint device was performed by our quality assurance (qa) supervisor.The graft arrived in a very poor condition, completely turned inside out and flattened.Therefore, it was not possible to conclude whether the observed absence of collagen was native or generated by the manipulation of the product.(11/213) a second retention sample from same lot and coated on same period and under same conditions as the involved device was visually inspected by our qa supervisor.No collagen peel-off was found.This second retention sample also underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(4315) no conclusion can be drawn.The conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacture.However, the product, as it was received, does not conform to the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.
Additional Manufacturer Narrative
(3340/3345/213) one retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(11) the investigation is still ongoing as the involved product is to be sent for evaluation.A follow up report will be sent upon completion of the investigation.

• Brand Name: CARDIOROOT WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7446496
• Report Number: 1640201-2018-00014
• Device Sequence Number: 16586480
• Product Code: DSY
• UDI-Device Identifier: 00384401013891
• UDI-Public: 00384401013891
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2018

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: HEWROOT0026
• Device Catalogue Number: HEWROOT0026
• Device Lot Number: 15F18
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/02/2018; 06/28/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/30/2018; 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1