MAUDE Adverse Event Report: INTERVASCULAR, SAS INTERGARD KNITTED GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number IGK0010-40

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Aneurysm (1708)

Event Date 03/13/2014

Event Type  Injury  

Event Description

During a bentall vascular surgery performed on (b)(6) 2014, it was reported that the graft was bleeding profoundly.The bleeding could be stopped by using clamps and some glue at sight.The graft remained implanted.No pt injury was reported.

Manufacturer Narrative

The device will be sent to an outside laboratory for scanning electron microscopy analysis.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 was found.Specifically, the review of the water permeability testing of twelve products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coating 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.The investigation is still on going.A follow-up report will be submitted upon completion of the investigation.

• Brand Name: INTERGARD KNITTED GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR, SAS; zone industrielle athelia i; laciotat ; FR
• Manufacturer (Section G): INTERVASCULAR, SAS; zone industrielle athelia i; laciotat ; FR
• Manufacturer Contact: pascal framond ; zone industrielle athelia i; laciotat ; FR ; 42084646
• MDR Report Key: 3766644
• MDR Text Key: 4485131
• Report Number: 1640201-2014-00009
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/14/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: IGK0010-40
• Device Catalogue Number: IGK0010-40
• Device Lot Number: 13G18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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