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

Model Number	IGK1809
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If new information was to become available, the file will be re-opened and updated.A follow up mdr will be sent.
Event or Problem Description
The product is used in the operation of an abdominal aortic aneurysm.When blood flow was resumed after anastomosis of the central part, blood leakage occurred from the entire artificial blood vessel.Remove the anastomosis and place an artificial blood vessel made by another company and finish the procedure.
Additional Manufacturer Narrative
(b)(4).If new information was to become available, the file will be re-opened and updated.A follow up mdr will be sent.
Event or Problem Description
The product is used in the operation of an abdominal aortic aneurysm.When blood flow was resumed after anastomosis of the central part, blood leakage occurred from the entire artificial blood vessel.Remove the anastomosis and place an artificial blood vessel made by another company and finish the procedure.
Additional Manufacturer Narrative
Trackwise id# (b)(4).10/213) the involved device was returned to an external and independent laboratory for examination.As part of their conclusion they mention : "no defects in the textile structure were observed which could explain the excessive permeability noticed during the implantation." the laboratory report was sent to our corporate medical officer to have his final comments.His observations concerning the case are as follows : "unfortunately the bleeding details are very limited however the surgeon opted to use a different graft to complete the procedure.There is no information regarding patient¿s preexisting conditions and anticoagulation regimen.Both could have played an important role in the event.Based on the observations contained in the lab report, it appears that the graft has no textile defects and that the macroscopic analysis does not show any aspect that could justify the bleeding observed.The fact that the bleeding was diffuse let me believe that it was more comparable to what we call ¿oozing¿ or ¿sweating¿ of the graft which is expected at de-clamping however it is only speculative at this point." (4315) the cause of the event remains unknown.(67) however, the conducted investigation, which included all available information and the testing we performed, suggests that the device was not defective at the time of manufacturing.(22) blood leakage is a foreseeable side-effect as indicated in the product instructions-for-use, and may be related to several causes including the preexisting condition of the patient and pre- or intra-operative anti-coagulation regimen.
Event or Problem Description
See initial mfr report # 1640201-2019-00078.Complaint # (b)(4).

• Brand Name: INTERGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9211455
• Report Number: 2242352-2019-01169
• Device Sequence Number: 10839295
• Product Code: DSY
• UDI-Device Identifier: 00384401000495
• UDI-Public: 00384401000495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2020
• Report Date (Section F): 02/14/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 02/28/2022
• Device Model Number: IGK1809
• Device Catalogue Number: IGK1809
• Device Lot Number: 17C23
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 01/20/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/08/2019; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 02/14/2020