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

Model Number HEWAA2410080810/1

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

A review of the complaint device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.The clinical details have been forwarded to the vice president, medical affairs, a former cardiac surgeon.From his analysis, the device likely played no role in the patient death.Most likely the event should be attributed to an unbalanced coagulation cascade induced by the complexity of the procedure, hypothermia and extended extra-circulatory support.

Event Description

During an arch replacement performed on (b)(6) 2015 to repair an aortic dissection, it was reported that the patient experienced intraoperative bleeding especially through the needle holes (500-600 ml/h).Platelet and coagulation factor were used to stop the bleeding.The duration of the operation was about 3 hours with nothing abnormal.Unfortunately, the hemostatic effect was not good, the patient eventually died of hemorrhagic shock.Additional clinical information indicated that anticoagulant medication was used before surgery, the act range during extracorporeal circulation was extremely high and the platelet data of the patient was low.

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: pascal de framond ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208134
• MDR Report Key: 5293011
• MDR Text Key: 33391343
• Report Number: 1640201-2015-00044
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010739
• UDI-Public: 00384401010739
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2019
• Device Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 14C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEPARIN
• Patient Outcome(s): Other