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

Model Number	IGK1407
Medical Device Problem Codes	Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that during an aorto bifemoral bypass procedure, the graft does not appear to be tight along its entire length and ¿oozes¿ after fitting.The customer indicates that the consequences cannot be assessed in the long term.No harm to the patient was reported.
Additional Manufacturer Narrative
(10/3233) a non-implanted fragment of the graft which is contaminated with the patient's blood was sent to an external and independent laboratory for examination.The investigation is ongoing.(4109/213) the analysis of historical data indicated that no other complaint was reported for the same sterilization lot number 22l24.(4121/213) the device history records review concludes that no deviation was identified in relation with the reported event.(11/3233) one retention sample was selected from the same sterilization lot number with the same fabric type (knitted) and the same coating parameters as the involved product.A visual inspection and water permeability testing of the retention sample is ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
(10/213) a non-implanted fragment of the graft was examined by an external and independent laboratory.In conclusion, the macroscopic analysis of the fragment did not find any macroscopic defects in the textile structure.(11/213) one retention sample was selected from the same sterilization lot number with the same fabric type (knitted) and the same coating parameters as the involved product.A visual inspection of the retention sample was performed by a qualified quality control technician.It was concluded that the product is in compliance with the product specifications.The retention sample subsequently underwent a water permeability testing and the test result is within specification (<5ml/min/cm²).(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
Complaint # (b)(4).
Additional Manufacturer Narrative
Corrected data: the block h6, medical device ¿ problem code has been updated from "1506" to "2993" based on the investigation findings and the limited information provided as mentioned below.Additional manufacturer narrative: (4111/213) in order to identify the root cause of the reported event, additional information regarding the surgical procedure and the patient's conditions was requested to the customer from (b)(6) 2024.No further information was provided despite our efforts.The pharmacist has only indicated on (b)(6) 2024 that the surgeon is not a new user of this brand and has been using it for many years.Therefore, the investigation was concluded with the information available.(3331/213) additional manufacturing data on the rejection rate during the air permeability test was analyzed for the manufacturing period which includes the date of air permeability test performed for the involved device ((b)(6) 2022).No abnormal trends were observed regarding the rejection rate of the air test for the reference of product igk1407.Air permeability test is a non-destructive in process control performed on every product (100%).It provides further evidence that all coated products meet the expected performance.(410/213) occurrence of bleeding events are reviewed monthly during quality meeting.During last meeting ((b)(6) 2024) the bleeding events rates on intergard products family were within the maximum anticipated by the product risk assessment.(12/415) based on the analysis of the investigation findings and since no further information was provided by the customer upon our request, it is not possible to conclude on the exact origin of the cause of the adverse event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.To be noted that bleeding is an undesirable side-effect as indicated in the current product instructions for use, in the "undesirable side-effects" section.
Event or Problem Description
Complaint # (b)(4).

• Brand Name: INTERGARD KNITTED BIFURCATED GRAFT
• 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
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 20471075
• Report Number: 1640201-2024-0000015
• Device Sequence Number: 12665723
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: (01)00384401000471
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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 Model Number: IGK1407
• Device Catalogue Number: IGK1407
• Device Lot Number: 22L24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 11/20/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/13/2024; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown