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

Model Number IGK0008-70

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/04/2014

Event Type  Injury  

Event Description

During an aortic valve replacement performed on (b)(6) 2014, the involved graft was anastomosed to the subclavian artery and connected to an artificial heart-lung machine for blood transmission.During the extra corporeal circulation, the graft was reported to leak.No pt injury was reported.

Manufacturer Narrative

Note: all info contained in this report is provided by the mfr.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 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 120 mmhg as aper iso 7198.The test result indicated a value well within product specifications.The device was not used in an approved indication.No conclusion can be drawn.However, all available info and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: INTERGARD KNITTED GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR; zi athelia i; laciotat 1360 5; FR 13605
• Manufacturer Contact: pascal de framond ; zi athelia i; laciotat 13605 ; FR 13605 ; 42084646
• MDR Report Key: 4332280
• MDR Text Key: 5143485
• Report Number: 1640201-2014-00034
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: IGK0008-70
• Device Catalogue Number: IGK0008-70
• Device Lot Number: 13K17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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): Other