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

Model Number HEWROOT0032

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to established procedures and no anomaly was found.Specifically, the review of the mechanical test results (suture retention testing strength at 45° and 90°, and longitudinal tensile strength) obtained on the same fabric as the complaint device indicated values within product specifications.No conclusion can be drawn.However, the investigation performed would tend to indicate that the device was not defective.

Event Description

During a surgery performed on (b)(6) 2015, it was noted that the graft frayed at its proximal extremity.The graft was not implanted.The surgery was completed with another graft and without outcome for the patient.

Manufacturer Narrative

(10/38/213) the returned device was inspected by the qa/qc manager.The device shows signs of being unpacked and manipulated.There is no sign of a defective textile structure.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: CARDIOROOT GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• 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: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 4925185
• MDR Text Key: 22524894
• Report Number: 1640201-2015-00026
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 06/22/2015

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
• Device Operator: Other
• Device Expiration Date: 08/01/2016
• Device Model Number: HEWROOT0032
• Device Catalogue Number: HEWROOT0032
• Device Lot Number: 11H25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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