MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number IGW0028-15

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that, during implantation, when sutures were placed into the graft, a collagen flake was noticed inside the graft.The suspected graft was not used and another prosthesis was implanted without any consequence for the patient.

Manufacturer Narrative

(b)(4) a review of the device history records indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable qa inspections and tests including a 100% visual inspection.No anomaly was found.(b)(4) an examination of the complaint device confirmed the presence of a small isolated flake that most probably comes from the graft coating itself.(b)(4) the most probable root cause is an isolated human error.This anomaly should have been evidenced during quality control inspections.A corrective action is initiated.

• Brand Name: INTERGARD WOVEN GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 4472654
• MDR Text Key: 5398781
• Report Number: 1640201-2015-00003
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 14E29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Patient Age: 82 YR