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

Model Number HEWAA2610080810/1

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/07/2022

Event Type  Death  

Event Description

It was reporting to intervascular that a patient underwent a acute dissection a surgery.During the surgery, the connect site of the branch was bleeding.The doctor stithched up again to complete the surgery and the product remain implanted.The bleeding occurred around the connection between the branches and body.There was difference between the first and second suturing that is to say that the doctor sutured the bleeding site second time as the first time to stop the bleeding.The doctor used the same suture during these two suturing, the usual surgical instruments was used ¿bloding clamper duiting the operation".The procedure prolonged around 6 hours and the total procedure last 12 hrs and 40 mins.The amount loss of blood was around 2000ml.The patient required the blood transfusion: red blood cell 10u, blood platelet 2u, plasma 800.The length of stay in hospital was 10 days.The patient died a month after the operation.

Manufacturer Narrative

(b)(4).Remained implanted.

Manufacturer Narrative

(3331/213) as part of the non-conformity report, based on all the investigation elements and a deeper investigation of production records, the quality assurance (qa) manager concluded the following: "following the analysis of all the data, there are no elements that could question the quality of the product.Moreover, as the complaint product was not returned for analysis, it is not possible to investigate further and conclude on the cause of the observed phenomenon." (11/213) one retention sample from same sterilization lot number was selected based on the same lot of collagen, as well as the branches are from the same textile runs as the involved device.A visual inspection performed by the quality assurance supervisor concluded that the product is in compliance with the specification.A waterpermeability testing was also performed on the selected retention sample.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

(4112/213) the case and its investigation have been reviewed by the medical affairs department whose initial assessment is below: "we received a complaint on (b)(6), 2022, from (b)(6) hospital in china concerning the use of an intergard woven aortic arch graft.Dr.(b)(6) performed an emergent aortic arch repair on (b)(6), 2022, on a 57-year-old male patient for an acute dissection.Due to bleeding at the anastomosis between the main body of the graft and one of the branches, the procedure took 12 hours, six more than expected by dr.(b)(6).The surgeon ran two layers of suture, coated the anastomosis with "hemostatic glue," and wrapped the defect with "patches" to stop the bleeding and repair the defect in the graft.The patient was hospitalized for ten days, returned home, and died one month after the initial surgery.The cause of death may have been due to an unspecified infection, but it has not been confirmed.The calculated blood loss during the surgery was estimated to be 2000 ml; the patient received multiple transfusions of red blood cells, plasma, and platelets.One hypothesis is that the diffuse bleeding along the graft anastomosis between the body and the branches could be related to improper handling of the device, excessive use of force, or the use of vascular clamps along the insertion of the branches, thus traumatizing the integrity of the coating of the graft.This hypothesis remains speculative as a final determination of the cause of bleeding cannot be conclusively described due to a lack of additional information and a graft specimen to submit for analysis.Hypothermia, circulatory arrest, and a prolonged run on the heart lung machine could have impacted the coagulation profile causing excess bleeding described by the surgeon in his report.Due to the nature of the bleeding and the patient's death, i have requested that this complaint be formally escalated for further investigation." following the request of medical escalation 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 this complaint is an isolated event and due to the limited information available it is not possible to conclude on the cause of the event and determine further investigation.The results were reviewed by the medical affairs department whose final assessment is below: "the intervascular team (production, r&d, quality, and qrc directors) and medical affairs held a complaint review meeting.The complaint description, investigation, and medical review were presented to the participants.After the presentation, the case was reviewed to determine what might have been the cause of bleeding.It was agreed upon that this was likely an isolated event.Due to the lack of information obtained after good faith efforts were made to communicate more fluidly with the surgeon and without the explanted graft to send for independent analysis, it was impossible to arrive at a definitive conclusion about the cause of bleeding.The results of this investigation will be sent to the surgeon." (4315/19) the investigation concluded that it was not possible to identify the exact origin of the event root cause since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.Moreover based on the medical review, one hypothesis is that the diffuse bleeding along the graft anastomosis between the body and the branches could be related to improper handling of the device, excessive use of force, or the use of vascular clamps along the insertion of the branches, thus traumatizing the integrity of the coating of the graft.

• 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: 15895190
• MDR Text Key: 304619979
• Report Number: 1640201-2022-00036
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: (01)00384401010746
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEWAA2610080810/1
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 21K14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male