MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED AXILLO BIFEMORAL GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number HGKAX0808

Device Problem Fluid/Blood Leak (1250)

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 12/22/2014

Event Type  Injury  

Event Description

During an axillo-bifemoral vascular surgery performed on (b)(6) 2014, when unclamping the proximal anastomosis, the graft was reported to bleed massively through the bypass tunnelling course.The bleeding was stopped by putting hemostatic gauzes, the graft remained implanted.It was also reported that the hospitalisation was prolonged due to an infection and dehiscence wounds.No patient injury was reported.

Manufacturer Narrative

(b)(4).A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly relative to the reported event 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.(b)(4).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.

• Brand Name: HEMAGARD KNITTED AXILLO BIFEMORAL GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 4589756
• MDR Text Key: 21452380
• Report Number: 1640201-2015-00012
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 14C13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR