MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGW0008-30

Device Problem Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The review of the complaint device history records concluded that there is no non-conformance / planned deviation in relation with the event reported.The review of historical data indicated that no other similar complaint was reported for the same lot number: 20j10.One retention sample was selected based on the following criteria: it was coming from the same sterilization lot and was coated on the same day and under the same conditions as the involved device.It was also inspected during manufacturing on the same day as the involved device.During the complaint investigation, this retention sample was visually inspected by the quality assurance supervisor.No visual defect, neither internal nor external, was found; the product is in compliance with the specifications.The involved product was returned to intervascular, and was inspected by the quality assurance supervisor for evaluation.Below are the main elements of the inspection results: the product reference matches with the product, the product has not been cut, the product is whole.There is a small deposit of collagen of about 5 mm inside the graft.It is similar to a collagen peel off with a risk of collagen detachment.This defect can be generated during the trimming step by making the collagen ¿crack¿ because there is a stretching of the product, or during the step of checking the diameter on the measuring cone.In addition, we have also observed a gray spot of the size of a pinhead coming from the inside but also visible externally, just after the deposit of collagen.It is either a mark left by the embossing mandrel or made by the hospital by wanting to look inside the prosthesis.This product should have been rejected during manufacturing at the qc step for the defect type, "lack of adhesion of the collagen layer¿.The conducted investigation would tend to indicate that the cause of the event is an isolated quality control deficiency.The graft should have been rejected during manufacturing at the qc step.Therefore, an internal non-conformity report has been initiated in order to confirm the root cause and take appropriate corrective actions if necessary.

Event Description

Complaint #: (b)(4).Before the implantation of the graft, the user recognized deposits on the inner layer of the graft.The problem was seen before the use, directly after opening the package, therefore no patient was involved.The surgery was not delayed.No details were provided by the user regarding the aspect of the deposits found on the inner layer of the graft.The product has been returned by the customer for further investigation.

• Brand Name: INTERGARD WOVEN STRAIGHT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• Manufacturer Contact: francoise gauduchon ; zone industrielle athelia i; la ciotat
• MDR Report Key: 10914011
• MDR Text Key: 219523622
• Report Number: 1640201-2020-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000037
• UDI-Public: 00384401000037
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/27/2020

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: Health Professional
• Device Model Number: IGW0008-30
• Device Catalogue Number: IGW0008-30
• Device Lot Number: 20J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1