MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED STRAIGHT GRAFT; VASCULAR POLYESTER GRAFT

Model Number	HGK0008-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the complaint device history records is ongoing.One retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value (0.09 ml/cm2/min) well within product specifications (< 5 ml/cm2/min).Please note however that, as per the product instructions for use, the use of knitted vascular graft as a conduit for cannulation is not an approved indication.Indeed, hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.Investigation is still ongoing.A follow up report will be sent upon complemention of the investigation.
Event or Problem Description
During the implantation of the involved graft as a cannula for an extracorporeal membrane oxygenation (ecmo), after ascending aorta replacement performed on (b)(6) 2017, the graft was reported to bleed.Indeed, after releasing the blood flow, diffuse bleeding was observed through the graft, which necessitated to replace it by another graft.It led to an extended operation time : the implementation of ecmo was retarded whereas the patient was in cardiogenic shock.No information about the consequence for patient could have been obtained at this date.
Additional Manufacturer Narrative
A review of the complaint device history records performed by our quality assurance supervisor indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.Please note that water permeability testing is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.The involved device was returned for examination and it was sent to an external and independent laboratory.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned graft and to evaluate the presence of collagen material.The analysis consisted of a macroscopic observation of the fragment and a scanning electron microscopy (sem).The sem analysis pointed out presence of collagen material infiltration with no significant abnormality such as tears, loss of textile cohesion, holes and signs of cut.The sem analysis corroborated the macroscopic analysis.No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective.

• Brand Name: HEMAGARD KNITTED STRAIGHT GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6493302
• Report Number: 1640201-2017-00008
• Device Sequence Number: 1268468
• Product Code: DSY
• UDI-Device Identifier: 00384401000938
• UDI-Public: 00384401000938
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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
• Operator of Device: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: HGK0008-40
• Device Catalogue Number: HGK0008-40
• Device Lot Number: 16L10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 80