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

Model Number IGK1206

Device Problems Off-Label Use (1494); Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported to intervascular that after the graft implantation, a leak in the graft was observed while testing.It was indicated that the product should be returned for examination.No further information has been provided to date.Complaint (b)(4).Additional information provided by the initial reporter indicates the graft was used during a bifurcated subclavian to femoral surgery.The graft was cannulated for testing and the leak was observed at the graft's bifurcation.The patient was on bypass, and the patient's coagulation parameters were normal.The patient experienced blood loss and the quantity is unknown.No other consequences for the patient were reported.The surgery was not delayed.

Manufacturer Narrative

Blocks b5 was updated with additional information provided by the initial reporter.(4111/4248) in order to clarify the event additional information was requested and received from the initial reporter.It was revealed that the graft was cannulated for testing, and the patient was on bypass.The information provided suggests that it is an off-label use that led to bleeding during the surgery.A meeting between the medical affairs team and the surgeon is scheduled in order to evaluate the case.(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 the retention sample was performed by a qualified quality control technician, which concluded that the product 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 of the investigation.(10/3233) it was reported that the graft is available and should be returned for inspection.(4111/3233) additional information was 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 22l10.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(11/3233) 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 and water permeability test 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.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(4111/4248) a meeting was held between the medical affairs team and the surgeon on 1st november 2023 in order to evaluate and better understand the adverse event.The following information was provided : a patient that was considered high-risk by the surgeon, with a history of renal failure presented with an acute aortic dissection (debakey iiib) was emergently operated.An intergard knitted bifurcated graft (14 x 7 x 7) was used off label to connect the right axillary artery and the femoral artery to the heart lung machine.Towards the end of the aortic repair the surgeon noticed that the graft had been bleeding constantly in localized fashion at the crotch of the graft.This can be seen clearly in a video clip provided by the surgical team.The bleeding was localized, but constant and was a considerable amount of bleeding over the course of a 2-to-3-hour surgical procedure.The exact amount of blood was not recorded.The patient died the day after the surgery.The graft has been sent to geprovas for analysis.During the call dr.Jain mentioned that he has used bifurcated grafts in this fashion before.(10/213/3233) the involved device has been sent to an external and independent laboratory for analysis (geprovas).The involved graft underwent a macroscopic analysis before cleaning, which did not reveal any macroscopic degradation on the pet membrane except surjet of blue monofilament evoking a location of leakage at the bifurcation.Further microscopic analysis after cleaning 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) further macroscopic and microscopic analysis of the involved graft after enzymatic cleaning of biological tissues was carried out by an external and independent laboratory.The results of the macroscopic and microscopic analysis of the grafts does not reveal any degradation of the textile structure.Microscopic analysis revealed no small holes.Based on the observations, there is no textile defects including microholes that could explaint the bleeding observed by the surgeon.(4112/4248) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "a high-risk patient (per the surgeon) with a history of renal failure presented with an acute aortic dissection (debakey iiib) was emergently operated by dr.(b)(6) in (b)(6) india on (b)(6) 2023.An intergard knitted bifurcated graft (14 x 7 x 7) was used off label to connect the right axillary artery and the femoral artery to the heart lung machine.During a call between dr.(b)(6) and the medical affairs team held on 1 nov 2023, dr.(b)(6) described the incident further.Towards the end of the aortic repair the surgeon noticed that the graft had been bleeding continuously in localized fashion at the crotch of the graft.This can be seen clearly in a video clip provided by the surgical team.The bleeding was described as localized, but constant and was thought to be a considerable amount of bleeding over the course of a 2-to-3-hour surgical procedure.The exact amount of blood was not recorded.The patient died the day after the surgery.The graft was analyzed at geprovas and found to have no evidence degradation of the textile structure macroscopically.Blue polypropylene sutures were present corresponding with the location where bleeding was observed in the crotch of the graft.Microscopic inspection did not reveal holes in the crotch.The retention sample was inspected and found to be withing specifications.Water permeability testing of the retention sample was performed and found to be within specifications.A review of historical data indicated that no similar complaint was reported for the same sterilization lot.The use of intergard knitted vascular grafts is contraindicated for use as a perfusion branch during extracorporeal circulation (excerpt from contraindications of product ifu).This use may result in excessive bleeding.During the call dr.(b)(6) mentioned that he has used bifurcated grafts in this fashion before, and that this use is not uncommon.Care should be taken to avoid excessive tension in sewn areas of bifurcated grafts, or the crotch of the graft (excerpt from warnings of product ifu).Damage of the collagen coating may result in excessive bleeding.There is no evidence that the graft was defective.The device was used off label for extracorporeal circulation and the crotch of the graft would appear to have been subjected to excessive tension by being placed in a configuration that spreads the limbs of the graft in order to bridge the distance between the right axillary artery and the right femoral artery.The higher pressures encountered during use of the device as a perfusion limb, together with the damage that may have occurred in the crotch of the graft potentially affecting the suture and the collagen coating may have caused the protracted bleeding that occurred during the procedure." (4110/213) occurrence of bleeding events and off-label use (olu) bleeding events are reviewed monthly during quality meeting, as per internal procedure.During last meeting ((b)(6) 2024), the bleeding events and olu bleeding events rates on intergard/hemagard products were within the maximum anticipated by the product risk assessment.(24) the investigation concluded that it was not possible to identify the exact origin of the adverse event.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.As mentioned in the medical assessment, the device was used off-label for extracorporeal circulation and the graft's crotch would appear to have been subjected to excessive tension during its use as a perfusion limb.This suggests that the cause of the bleeding may be linked to crotch damage potentially affecting the collagen coating.To be noted that as per the product instructions for use, intergard/hemagard knitted vascular grafts are not intended for use as perfusion branch during extracorporeal circulation, as this may lead to excessive bleeding.Indeed, intergard/hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of the abdominal aorta and peripheral arteries, when open surgical operation is required.

Event Description

Complaint # (b)(4).

• Brand Name: INTERGARD 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: 18073245
• MDR Text Key: 327400108
• Report Number: 2242352-2023-00920
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000464
• UDI-Public: (01)00384401000464
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024,02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGK1206
• Device Catalogue Number: IGK1206
• Device Lot Number: 22L10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2024
• Distributor Facility Aware Date: 01/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2024
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male