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

Model Number IGK0008-70

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported to intervascular that following the placement of the involved device, oozing occurred along its entire length.The oozing was abnormal and copious, resulting in significant blood loss.Additional information received from the initial reporter indicates that the device was used to connect the axillary artery to the artery line of extra corporeal circulation in aortic dissection type a.The patient was affected by valve aortic endocarditis, pre-op coagulating tests was normal.The act was > 400.The patient was under heparin, and antibiotics for the endocarditis.The surgeon replaced the already implanted prothesis with another of the same brand and dimensions just a few minutes later after the implantation.The amount of blood loss is unknown.Only one intervention on the patient was necessary.The intra and post operative course was uneventful.After that, the patient was fine.The surgeon linked this to a possible defect on the collagen coating.The device was explanted and will be returned to the manufacturer for examination.

Manufacturer Narrative

(10/3233) it was reported that the graft that was explanted and it is available.It will be returned for inspection.(4111/4248) additional information was requested and received from the initial reporter in order to clarify the event.It was revealed that the surgeon used the device to connect the axillary artery to the artery line of extra corporeal circulation in aortic dissection type a.To be noted that, as per the product instruction for use, intergard vascular grafts are not intended for use during extracorporeal circulation, as it may lead to bleeding.Therefore, it is an off-label use that could lead to bleeding during surgery as anticipated in the product risk assessment.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 23d20.(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 and water permeability test of the retention sample will be performed.((b)(4)) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(11/213) one retention sample from the same sterilization lot number with the same fabric type (knitted), the same coating date and coating parameters as the involved product was selected.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.

Manufacturer Narrative

(10/213/3233) the involved graft was returned to an external and independent laboratory for examination.The results of the macroscopic analysis of the graft did not reveal any macroscopic degradation on the textile membrane.Further macroscopic and microscopic analyses after cleaning biological tissues are being performed, results are pending.(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

(10/213) a macroscopic and microscopic analysis of the involved prosthesis after enzymatic cleaning of biological tissues was carried out by an external and independent laboratory.The laboratory concluded that the macroscopic and microscopic analysis of the prosthesis does not reveal any degradation of the textile structure.Microscopic analysis revealed no small holes.(4109/213) as part of the investigation, a review of historical data was conducted on sterilization lot number 23d27.There was no complaint reported on the same sterilization lot number 23d27.In conclusion, no other similar complaint was reported for both sterilization lot numbers 23d20 and 23d27 related to the involved prosthesis and its replacement, respectively.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).Additional information provided by the initial reporter indicated that the surgeon used a similar product referenced as intergard knitted straight (ref: (b)(4)) from another sterilization lot number 23d27.However, no information on the serial number was provided.

Manufacturer Narrative

(4112/4248) the case and its investigation have been assessed by the medical affairs department whose conclusion is below: the use of intergard/hemagard knitted vascular grafts for extracorporeal circulation is contraindicated as mentioned in the instructions for use.The investigation performed as well as the review of manufacturing records did not show any evidence that this graft was defective.Off label use of intergard/hemagard knitted vascular grafts for extracorporeal circulation may result in excessive bleeding.The replacement graft did not present bleeding as did the first device used.There is no additional information to understand the difference in performance of the two theoretically identical grafts.The pressures and hemostatic state of the patient were not provided.A definitive answer to why the grafts performed differently cannot be proven.(4111/3233) as part of the investigation, it was decided to schedule a meeting between the medical affairs team and the surgeon to better understand the reported event.A final medical assessment with the outcomes of this discussion 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

(4111/4112/4248) the case was escalated to the intervascular management team.Below is the final medical assessment conclusion following this escalation: "during the meeting the complaint was reviewed as well as the medical assessment.The outstanding topic that merited the medical escalation was the different performance observed by the surgeon between two seemingly identical grafts that were implanted in the same patient, in the same configuration, under what were described as the same circumstances.Of note, the grafts were used off-label as described within the text of the medical assessment.Multiple good faith attempts were made to communicate with the surgeon to determine if there was any possible explanation for this discrepancy.Unfortunately, medical affairs was not able to communicate with the surgeon.If there are any future communications between getinge and the surgeon; the medical assessment will be updated to reflect that exchange and complete this investigation." (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 (april 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.To be noted that as indicated in the contraindicaation section of 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 STRAIGHT
• 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: 17610037
• MDR Text Key: 321805262
• Report Number: 1640201-2023-00025
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000372
• UDI-Public: (01)00384401000372
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGK0008-70
• Device Catalogue Number: IGK0008-70
• Device Lot Number: 23D20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THE PATIENT WAS UNDER HEPARIN AND ANTIBIOTICS
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR