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	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that one of the branches of the prosthesis was leaking blood, after waiting for a while, no more leaks were detected, and it continued to be used on the patient during the surgery.No impact on patient was reported.
Additional Manufacturer Narrative
(4117) device is not accessible for testing as it remained implanted in the patient.(4109/213) the analysis of historical data indicated that no other complaint was reported for the same sterilization lot number 23d06.(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 will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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: (4111/3221) 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 17-oct-2024 to 11-nov-2024.No further information was provided despite our good faith efforts.Therefore, the investigation was concluded with the information available.Should new information regarding the patient condition or the outcome of the procedure become available, the investigation and complaint will be reopened.(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).(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 (31-mar-2023).No abnormal trends were observed regarding the rejection rate of the air test for the product reference (b)(4).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.(4110/213) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In november 2024, the bleeding rate on intergard/hemagard grafts was below the maximum anticipated by the product risk assessment.(22/4315) based on the investigation findings, the inability to examine the involved product as it remained implanted and the lack of further information provided by the customer, no conclusion can be drawn on the exact origin of the reported adverse event.However, the conducted investigation and testing performed suggest 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: 20598645
• Report Number: 1640201-2024-0000026
• Device Sequence Number: 6550397
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: (01)00384401000471
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 23D06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown