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

Model Number	IGW0026-30
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.One retention sample from same sterilization lot as the involved device was visually inspected by the quality assurance supervisor.No stain/halo was found on the internal and external lids, which could be in relation with the event.The retention sample is in compliance with the specifications from a product/packaging point of view.The pictures sent by the customer were inspected by qa supervisor.Main elements of his assessment are as follows: the oily stains observed on the pictures sent by the customer on the inner lid look like glycerol stains that do not affect the quality of the product, since glycerol is an integral part of the product.This phenomenon of oozing could be accelerated depending on the final and intermediate storage conditions.This defect is known and acceptable.The conducted investigation indicates that the involved product complies with specifications.The observed glycerol stains do not constitute an unusual phenomenon and do not affect the product quality and performance.Device remains implanted.
Event or Problem Description
When opening the box, the physician noticed that there were stains on the cover of tray.The outer box was clean, so the physician did not realize the contamination before opening the box.Normally, the physician refuses to use devices with this kind of contamination.However, it was an emergent operation in midnight, and there was no substitute graft in the hospital, so the physician still inserted it in the patient.Patient status is stable currently.

• Brand Name: INTERGARD WOVEN STRAIGHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11284814
• Report Number: 1640201-2021-00005
• Device Sequence Number: 3843059
• Product Code: DSY
• UDI-Device Identifier: 00384401000228
• UDI-Public: 00384401000228
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: IGW0026-30
• Device Catalogue Number: IGW0026-30
• Device Lot Number: 20G23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1