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

Model Number	HEK08/75CPUT(1)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(4117) based on the initial information received the involved device is not accessible for testing as it remained implanted in the patient.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 25b20.(3331/213) the device history records review concluded that there was no deviation in relation with the reported event.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that an excessive suture hole bleeding was noticed while implanting and suturing a hemacarotid patch ultrathin 8x75mm using prolene 6-0 c1 suture and needle.The bleeding was controlled using protamine, tachosil and by allowing time for bleeding to stop.
Event or Problem Description
Complaint # (b)(4).
Additional Manufacturer Narrative
Corrective data: on block h6, the medical device problem code "3190" was updated to "2993" following the investigation results.Additional manufacturer narrative: (4111) following our surgeon contact, the following information has been provided: the procedure was prolonged by 30 to 40 minutes, there is no consequence for the patient.The pre-operative medications provided to the patient was: platelet inhibitors, anticoagulants, heparin, ascal and clopidogrel (herparin before clamping and all medication as given to this patient is standard procedure) the vascular diagnosis: 7/6 tia bij stenose carotis, the procedure performed was a carotid endarterectomy , indication for surgery: tia , the amount of blood loss was 300cc, the patient did not required blood products, actions taken to stop the bleeding: protamine, tachosil and waiting the hemostasis, where was the patch implanted at the carotid bifurcation, the surgeon is not a new user intergard product.(4112/213) the case and its investigation have been reviewed by the medical affairs department who concluded that: "it is unclear if the bleeding can be attributed to the patient¿s coagulation profile or the patch.Needle hole bleeding is not uncommon and can be caused by surgical technique, altered coagulation profiles, or inherited bleeding disorders.While some bleeding was observed along the surface of the patch, the main concern reported was the needle hole bleeding.Needle hole bleeding would not likely be caused by the patch." (22/4310) as indicated in the medical assessment, needle hole bleeding is not uncommon and can be attributed to the surgical technique, altered coagulation profiles, or inherited bleeding disorders.While some bleeding was observed along the surface of the patch, the main concern reported was the needle hole bleeding.The adverse event would not likely be caused by the patch.The conducted investigation suggests that the product was not defective at the time of manufacturing.It should be noted that bleeding is an undesirable side effect as indicated in the current product instructions for use, in the "undesirable side effects" section.

• Brand Name: HEMACAROTID KNITTED ULTRATHIN
• 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: 22671540
• Report Number: 2242352-2025-00907
• Device Sequence Number: 11718607
• Product Code: DSY
• UDI-Device Identifier: 00384401001478
• UDI-Public: (01)00384401001478
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Importer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025
• Report Date (Section F): 11/24/2025

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: HEK08/75CPUT(1)
• Device Catalogue Number: HEK08/75CPUT(1)
• Device Lot Number: 25B20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLATELET INHIBITORS, ASCAL, CLOPIDOGREL, HEPARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/24/2025