MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HEWAA2010080810/1

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2023

Event Type  Injury  

Manufacturer Narrative

(4117) the device is not available for testing.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 18g12.(3331/3233) a review of the device history records is pending.(11/3233) one retention sample from the same sterilization lot number, coated on the same day and under the same coating parameters as the involved device was selected.A visual inspection and water permeability testing will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Product not available for testing.

Event Description

It was reported to intervascular that during surgery bleeding occurred at the time of venting the graft after vascular anastomosis.It was observed locally and along a suture line.About 50 cc of blood was lost.The pre-operative coagulation parameters of the patient were inr0.96/pt12/ptt27.No blood transfusion and bleeding was stopped using coreseal glue.The surgeon decided to replace the involved graft by a hemashield platinum aortic arch (m00202175924p0) to complete the surgery.No consequence for the patient was reported.

Manufacturer Narrative

Corrected data: the block d7a has been corrected.Additional manufacturer narrative: (4111) in order to better understand the event, complementary information was received: the bleeding occurred on the side branch at of the manufacturer's anastomosis line.The "side branch" refers to the upper proximal branch.Although the bleeding was stopped using coreseal glue, the graft was replaced because the surgeon was concerned that it would still bleed when the patient returned to the ward.The surgeon is a regular user of hemashield and intergard products.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(11/213) one retention sample from same lot number was selected based on the same coating parameters and same fabric type as the involved device.A visual inspection and a waterpermeability testing were performed.The visual inspection performed by a quality control technician and the production supervisor concluded that the product is in compliance with the specification.A water permeability testing was also performed, the test result is within specification (< 5 ml/cm²/min).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(4112/3233) the case and its preliminary investigation results have been reviewed by the medical affairs department whose initial assessment is below: "this complaint concerns an incident of bleeding reported on (b)(6) 2023 from beijing anzhen hospital in china during the implantation of an intergard woven aortic arch.While venting the graft, the surgeon noticed bleeding from the "proximal upper branch" after completing the vascular anastomosis.The bleeding was localized and presented along the manufactured anastomotic line of the branch.Blood loss was estimated to be approximately 50 ccs.Initially, coseal was used to stop the bleeding; but the surgeon ultimately decided to replace the intergard woven aortic arch with a hemashield platinum aortic arch.The explanted graft was not returned for analysis.The patient's coagulation profile was normal.There was no other information regarding the patient or the procedure.The local representative stated that the surgeon uses both intergard and hemashield grafts.The area that was bleeding was described as the proximal upper limb.An image from the procedure shows what would appear to be a stream of blood coursing down the body.Due to the lack of information provided and the inability to communicate directly with the surgeon, a definitive conclusion cannot be reached regarding the cause of the bleeding.Due to the description of localized bleeding at the area of the anastomosis of one specific branch of the device, medical affairs would like to request a formal escalation to better assess this event." (3331/3233) upon the request of the medical affairs department, an internal non-conformity report has been opened to deepen the investigation with regard to manufacturing data.The results are pending.(11) the investigation is still ongoing and, a follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

(3331/213) as part of the investigation and in response to the medical escalation request, a non-conformity report was opened in order to further investigate on the manufacturing part.It concluded that based on the analysis of the investigation findings there are no element that could question the quality of the product at the time of manufacturing.(4112/213) as requested, a meeting was held with the management team of intervascular and the medical affairs team in order to review the case.It was concluded that it is not possible to conclude on the cause of the event and no further investigation is possible.The results were reviewed by the medical affairs department whose final assessment is below: "as part of the conclusion of the initial medical assessment from on (b)(6) 2023.A medical escalation was requested to further investigate the manufacturing of the device in question.During a multi departmental video call, the quality assurance tests and inspections were reviewed, as well as the performance and training of the seamstress that was reviewed and found to be satisfactory.No further investigations are required." (4315) based on the investigation results and medical assessment, no conclusion can be drawn on the exact origin of the adverse event as the product was discarded and could not be analyzed and due to the lack of information from the initial reporter.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

Event Description

Complaint#: (b)(4).

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• 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: 16710131
• MDR Text Key: 312988828
• Report Number: 2242352-2023-00296
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401103868
• UDI-Public: (01)00384401103868
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: HEWAA2010080810/1
• Device Catalogue Number: HEWAA2010080810/1
• Device Lot Number: 18G12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2023
• Distributor Facility Aware Date: 06/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2023
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORESEAL GLUE.
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female