MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED ULTRATHIN GRAFT

Model Number	HGKUT0008-20
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 120mmhg as per iso 7198.The test result indicated a value well within product specifications.The returned complaint device was sent to an external laboratory for macroscopic and sem examination.The investigation is still on-going.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
During an aortic dissection performed on (b)(6) 2016, the graft was used for axillary cannulation.It was reported that blood leaking occured at several parts of the graft.No adverse outcome for the patient was reported.

• Brand Name: HEMAGARD KNITTED ULTRATHIN GRAFT
• Common Device Name: HEMAGARD KNITTED ULTRATHIN GRAFT
• 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: francoise gauduchon ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5722730
• Report Number: 1640201-2016-00008
• Device Sequence Number: 16765529
• Product Code: DSY
• UDI-Device Identifier: 00384401014751
• UDI-Public: 00384401014751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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 Expiration Date: 09/30/2020
• Device Model Number: HGKUT0008-20
• Device Catalogue Number: HGKUT0008-20
• Device Lot Number: 15K15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: 02/09/2016
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 06/14/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male