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

Model Number IGW0030-30

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.A mismatch between the graft (diameter 8mm) and its labeling (diameter 30mm) was confirmed.It was noticed that both inner and outer blisters were open.Upon investigation and review of the complaint device history records, it appears that this discrepancy is related to an isolated human error which occured during a manufacturing steps.As a correction, the corresponding mislabeled product was found and immediately segregated.As a corrective action, a working group is currently conducting an analysis of the issue to prevent such incident from reoccurring.In addition, the manufacturing staff has been informed of the issue and will be retrained.

Event Description

While opening the graft before a surgery, a 8 mm diameter graft was found in the package whereas the product is labeled as a 30mm-diameter.The device was not used and placed back in the box.It was returned for evaluation.

Manufacturer Narrative

The segregated product has been returned as part of a recall.No other product was involved in this issue.Additional narrative and corrected data: this mdr is one of a series of four resubmissions.Indeed, following the fda's email dated june 24th, 2020 informing us on an issue about the initial mdr #16402201-2016-00008 which was not received, and the confirmation of an error of submission environment on july 6th, 2020, an internal non-conformity report was initiated on july 6th, 2020 in order to investigate the root cause of the issue and take appropriate corrective actions.In this context, the mdr # 16402201-2016-00008 was resent on july 10th, 2020 and three additional mdr's were identified as affected by the same discrepancy (original submission in the test environment instead of the production environment): initial mdr # 1640201-2016-00007, supplemental report 1 for mdr # 16402201-2016-00004 and supplemental report 2 for mdr # 16402201-2015-00024.It is why we are resubmitting today the present report with the original data.Only the contact part g1-2 was corrected to provide the updated contact information and h10 was supplemented to add details concerning the resubmission.We apologize for this issue.

• Brand Name: INTERGARD WOVEN GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5427141
• MDR Text Key: 37986151
• Report Number: 1640201-2016-00004
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000266
• UDI-Public: 00384401000266
• Combination Product (y/n): N
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: IGW0030-30
• Device Catalogue Number: IGW0030-30
• Device Lot Number: 15F18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2015
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: 03/08/2016
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1