MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD AORTIC ARCH WOVEN; VASCULAR POLYESTER GRAFT

Model Number	HEWAA2810080810/1
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.Please note that water permeability testing is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.(b)(4).One retention sample coated on the same period and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(b)(4).No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective.
Event or Problem Description
It was reported that, on (b)(6) 2018, during a surgery for an aneurysmal disease, a serious bleeding was observed from the graft.The blood loss was about 5.5k cc and a transfusion was required during the surgery.Hemostatic agent (novoseven[sup]) and blood plasma cryoprecipitate were used to stop the bleeding.The graft remained implanted.No consequence for the patient was reported.
Additional Manufacturer Narrative
The case has been submitted to the corporate medical officer for review, with two other similar cases reported together by the same physician (mdr # 1640201-2018-00008 & 164201-2018-00009).His medical opinion is reported as follows: "we have received three complaints regarding complex aortic surgeries performed at same institution in china by the surgeon.Very limited information has been collected regarding the preexisting conditions of the patients.In all cases a very significant blood loss from the totality of the vascular grafts, from 3.5 to 5.5 liters.For all cases hemostatic agents were required to stop the bleeding.The procedures were significantly delayed by the hemostatic management.Ultimately the blood loss was controlled and the graft remained implanted in all cases.Similarly, all patients had no clinically significant consequences due to the events described.The limited information provided don't allow a clinical assessment.However the magnitude of the blood loss was very significant.The cause of the bleeding was unknown.Despite the normal post-operative course, the patients could have experience very serious consequences that could have been life-threatening." the additional information does not modify the conclusion provided in the initial report.
Event or Problem Description
The graft was used during a surgery with ecc (extracorporeal circulation) for an aortic aneurysm.The bleeding was observed from both main body and branches (including perfusion branch).

• Brand Name: INTERGARD AORTIC ARCH WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7341086
• Report Number: 1640201-2018-00010
• Device Sequence Number: 19267616
• Product Code: DSY
• UDI-Device Identifier: 00384401010753
• UDI-Public: 00384401010753
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: HEWAA2810080810/1
• Device Catalogue Number: HEWAA2810080810/1
• Device Lot Number: 17K19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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
• Patient Age: 73 YR