MAUDE Adverse Event Report: Intervascular SAS Intergard Standard Knitted bifurcated graft; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Model Number	IGK1809
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to intervascular that during the surgical procedure, porosity of the graft was identified at several locations, resulting in bleeding from multiple positions.The bleeding stopped spontaneously and the patient is currently in good condition.The patient is well and stable.Complaint (b)(4).
Event or Problem Description
Complaint (b)(4).
Additional Manufacturer Narrative
(4111) as part of the investigation, procedure and patient information has been requested to the surgeon to better understand the reported event.The following information has been provided on august-20th-2026: the patient underwent an aortic aneurysm resection and aortobifemoral bypass using an 18 × 9 mm dacron graft for the treatment of a tasc ii type d lesion associated with an abdominal aortic aneurysm (aaa) and leriche syndrome.The patient's medical history included hypertension, hypercholesterolemia, cardiomyopathy, and myocardial infarction (mi).The patient was receiving antiplatelet therapy preoperatively.Pre-operative coagulation parameters were pt 13.1 seconds, aptt 25.2 seconds, and inr 1.09.After declamping, diffuse bleeding occurred through the graft and graft porosity.The bleeding lasted approximately 2 to 3 minutes and ceased spontaneously.The estimated intraoperative blood loss was 300-400 ml.The procedure was prolonged by approximately 5 minutes.A transfusion of packed red blood cells (prbcs) was required.The length of hospital stay was prolonged by 1 day.(11/ 213) one retention sample from same sterilization lot number was selected based on the same coating and same textile parameters as the involved device.A water permeability testing was performed on the retention sample.The test result indicated a value which is within product specifications (< 5 ml/cm²/min).(3331/3233) the device history records review is still ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
Corrected data: h3 - added information about device remaining implanted in the patient.H4 - added manufacture date.H5 - added labeled for single use "yes." h6 - type of investigation added codes 4117 and 4109.(4111) as part of the investigation, procedure and patient information has been requested to the surgeon to better understand the reported event.The following information has been provided on august 20th 2026: the patient underwent an aortic aneurysm resection and aortobifemoral bypass using an 18 × 9 mm dacron graft for the treatment of a tasc ii type d lesion associated with an abdominal aortic aneurysm (aaa) and leriche syndrome.The patient's medical history included hypertension, hypercholesterolemia, cardiomyopathy, and myocardial infarction (mi) and benign prostatic hyperplasia (bph).The patient was receiving platelet inhibitors, statins, antihypertensive, tamsulosin and aspirin therapy preoperatively.Pre-operative coagulation parameters were pt 13.1 seconds, aptt 25.2 seconds, and inr 1.09.After declamping due to porosity of the graft there was bleeding for around 300-400ml which lasted around 2-3 minutes and ceased spontaneusly.The procedure was prolonged by approximately 5 minutes.A transfusion of packed red blood cells (prbcs) was required.The length of hospital stay was prolonged by 1 day.

• Brand Name: Intergard Standard 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 ; +033()442084646
• MDR Report Key: 50591580
• Report Number: 2242352-2026-00012
• Device Sequence Number: 21349074
• Product Code: DSY
• UDI-Device Identifier: 00384401000495
• UDI-Public: (01)00384401000495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Importer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026
• Report Date (Section F): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IGK1809
• Device Catalogue Number: IGK1809
• Device Lot Number: 22G21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/08/2026