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

Model Number	HEK14/75CPUT (1)
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following incident was reported to intervascular that porosity of the device observed after the placement of a carotid patch during the intervention (left internal carotid) and this, at a distance from the prolene needles holes.Bleeding was observed across the "unsealed" patch.Consequences: diffuse bleeding despite hemostasis; protamine and manual compression by the operator ; extension of interventional and anesthetic times; application of an additional patch.Action(s) taken: injection of protamine to neutralize the heparin ; manual compression for several minutes to achieve hemostasis addition of surgicel.The patch has been implanted and another one has been added.The product will not be returned for inspection.
Additional Manufacturer Narrative
More information is being requested to the initial reporter in order to investigate and identify the root cause.(b)(4).
Additional Manufacturer Narrative
Corrected data: on block h6, based on the investigation conclusion, the initial problem code "3190" was updated to "4001" and "1420", additional manufacturer narrative: three attempts were sent to the initial reporter to obtain more information in order to investigate and identify the root cause.No response was received from the initial reporter.(4112/213) the case has been reviewed by our corporate medical department whose assessment is below: "the event which precipitated this complaint is described as an open surgical carotid procedure where an intergard carotid patch was implanted on the left internal carotid artery.The complainant reported diffuse bleeding through the patch itself (ie not along the suture line) which required manual compression for several minutes, protamine administration, use of surgicel and the application of an additional patch (on top of the original patch).These reported measures to achieve hemostasis prolonged the surgical procedure and anesthesia time for the patient.There were no other patient complaints or adverse outcomes mentioned.As the original patch was left in place, there is no product to be returned and analyzed.A review of the device history record did not reveal a nonconformance issue.A limited amount of graft blushing would not be unusual during a carotid endarterectomy procedure, however after reversal of heparin and manual compression, it would be expected that the blushing would dissipate.The cause could be multifactorial and may be related to coagulation parameters, however because of the limited information provided, it is impossible to comment further on possible causes for the bleeding." (4110/213) occurrence of bleeding events is reviewed monthly during quality meeting, as per our internal procedure.During last meeting ((b)(6) 2022), the bleeding rate on intergard / hemagard products was within the maximum anticipated by the product risk assessment.(4315 - 50) no conclusion can be drawn on the exact origin of the adverse event since the product remained implanted and that the defect could not be reproduced/confirmed through the analysis of a retention sample.The conducted investigation concludes that the product was not defective at the time of manufacturing.However, based on medical assessment, the cause of the bleeding could be multifactorial and may be related to patient's coagulation parameters.
Event or Problem Description
Complaint # (b)(4).

• Brand Name: INTERGARD/HEMAGARD HEMACAROTID KNITTED UT
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13822223
• Report Number: 1640201-2022-00009
• Device Sequence Number: 4348386
• Product Code: DSY
• UDI-Device Identifier: 00384401001508
• UDI-Public: (01)00384401001508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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 Expiration Date: 11/30/2022
• Device Model Number: HEK14/75CPUT (1)
• Device Catalogue Number: HEK14/75CPUT (1)
• Device Lot Number: 21M02
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown