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

Model Number HGK1608

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/22/2023

Event Type  Injury  

Event Description

It was reported to intervascular that when the patient with infrarenal aaa and aortoiliac occlusive disease underwent an open aaa repair and aorto-bifemoral bypass with the involved graft, the surgeon noticed that blood was soaking through the device.The surgeon linked this to a possible defect in the graft's porosity or the collagen coating.Indeed, heavy bleeding from the limbs of the graft was reported.The surgeon reported that he pulled the graft back out of the retroperitoneal tunnel to see if there was a tear in it, and there was not.Currently, the majority of the graft is implanted in the patient at the aorto-bifemoral position and the remaining part of the graft will be returned to the manufacturer for analysis.The adverse outcome was significantly more blood loss and transfusion required.Patient is recovering to this point without apparent complication.

Manufacturer Narrative

(10/3233) it was reported that the fragment of the graft that was not implanted in the patient is available.It will be returned for inspection.(4111/3233) more information has been requested to the initial reporter in order to clarify the event.Responses are pending.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22j08.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(11/213) one retention sample from the same sterilization lot number was selected based on the same fabric type (knitted) and the same coating date and parameters as the involved product.A visual inspection of retention sample was performed by two quality control technicians, the production supervisor and the quality assurance supervisor, it is concluded that the retention sample is in compliance with the specifications.A water permeability testing was also performed on the retention sample.The test result is within specification.(11) the investigation is still ongoing.A follow up report will be sent upon completion.

Event Description

Complaint # (b)(4).Additional information provided by the surgeon indicates that the surgical procedure was prolonged by 30 min and the patient lost 300 cc of blood.The bleeding was noticed after the aortic anastomosis and throughout the graft (blushing).The surgeon re-clamped the graft in order to stop the bleeding.No consequence on the patient was reported.

Manufacturer Narrative

(4111) blocks b5 and b7 were updated with additional information provided by the surgeon regarding the reported bleeding event and the patient's medical history.(10/3233) three fragments of the product were returned for inspection to an external and independent laboratory for examination.The results of the macroscopic analysis revealed no degradation on the fabric structure.Further microscopic analysis is being performed, results are pending.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Manufacturer Narrative

(10/213) following a macroscopic analysis of the device fragments involved, a macroscopic and microscopic analysis after cleaning biological tissues was performed by the same external and independent laboratory.Their conclusions is as follows: ¿ the macroscopic analysis of the prosthesis does not reveal any degradation of the textile structure.There is no small microholes seen during the microscopic analysis.However, a local loosening of the textile mesh can be assumed." the laboratory report was reviewed by the textile manager with regard to the textile loosening.After reviewing the microscopic pictures, they concluded that no visible degradation, such as fiber tearing, missing wires, or holes, that could explain a loss of performance, was observed.Moreover, it was highlighted that intergard/ hemagard knitted prostheses are composed of two layers, one knitted and one made using the reverse lock knit technique (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint (b)(4).

Manufacturer Narrative

(4112/213) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint refers to a case of bleeding during an abdominal aortic aneurism repair.A hemagard knitted aorto bifemoral graft was implanted on (b)(6) 2023 into a 71 y/o woman with a history of hypertension, hypercholesterolemia, atrial fibrillation, and a prior femoral popliteal bypass.After creation of the aortic anastomosis the surgeon observed bleeding from the limbs of the graft that prompted him to remove the graft from the retroperitoneal tunnel.The surgeon remarked that the bleeding reminded him of older knitted grafts that required preclotting.Upon observing the bleeding, the surgeon reclamped the aorta and removed the distal portion of the graft including the limbs, sewing in a different graft to complete the procedure.Approximately 300 ccs of blood were lost and there was no consequence to the patient.The portion of the graft that was removed was sent to geprovas, an independent and external laboratory, for analysis and showed no macroscopic degradation of the pet.The surgeon is not a new user of hemagard products.Different patients may bleed more depending on how the graft is handled, anticoagulation, prior medical history, and blood pressure.A definitive conclusion of the cause of bleeding cannot be reached.The results of the microscopic analysis performed at the laboratory did not show microholes, but a local loosening of the textile mesh is possible as suggested by the residual blood impregnation shown in the report, that corresponds with the location where the surgeon described the bleeding to occur.It is unclear if this potential loosening of the textile mesh was preexistent of occurred during the procedure." (4110/213) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In (b)(6) 2023, the bleeding rate on intergard/hemagard grafts was below the maximum anticipated by the product risk assessment.(67) based on the investigation findings and the medical review, 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.The examination results of returned fragments did not reveal any degradation of the textile structure, that could explain a loss of performance.The root cause of reported bleeding is potentially linked to different factors such as the manner in which the graft is handled and the patient's conditions.A definitive conclusion on the root cause of the reported bleeding cannot be reached.(22) to be noted that bleeding is an undesirable side-effect as indicated in the product instructions for use.

Event Description

Complaint # (b)(4).

• Brand Name: HEMAGARD KNITTED BIFURCATED
• Type of Device: 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: 17342842
• MDR Text Key: 319325181
• Report Number: 1640201-2023-00019
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014027
• UDI-Public: (01)00384401014027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HGK1608
• Device Catalogue Number: HGK1608
• Device Lot Number: 22J08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 11/06/2023; 12/04/2023
• Supplement Dates FDA Received: 09/25/2023; 12/01/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APIXIBAN, LIPITOR, LISINIPRIL AND PAXIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 75 KG