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

Model Number	HEWROOT0030
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not accessible for testing.A review of the complaint device history records is ongoing, results are pending.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that the graft had thread unraveling on its end.The surgeon cut the clean area and used the graft.No patient injury.
Additional Manufacturer Narrative
(3331/213) 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.(67) no conclusion can be drawn since the defective portion of the product was not returned for examination.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.Please note that, due to their intrinsic weaving pattern, woven grafts are prone to fraying.As indicated in the product instructions for use, a low-temperature disposable cautery should be used to minimize fraying when cutting this graft.

• 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: 8406450
• Report Number: 1640201-2019-00019
• Device Sequence Number: 16687024
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: 00384401013914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 04/30/2022
• Device Model Number: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 17E04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/10/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1