MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN; VASCULAR POLYESTER GRAFT

Model Number	M00202175824P0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
((b)(4)) the review of the complaint device history records 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.((b)(4)) one retention sample coated on the same period and under the same conditions as the involved device will be tested for water permeability.((b)(4)) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that during an emergency case (type a dissection), the involved graft was used to repair the aorta and was reported to "blush" more than before.The surgeon didn't replace the device as it was already sutured.The graft remained implanted, no blood transfusion and no consequence action taken to the patient.
Additional Manufacturer Narrative
(b)(4) one retention sample coated on the same period and under the same conditions as the involve device underwent water permeability testing.The testing was supervised by our quality assurance supervisor.The test result indicated a value well within product specifications (< 5 ml/cm2/min).(b)(4) 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: HEMASHIELD PLATINUM WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6493079
• Report Number: 1640201-2017-00010
• Device Sequence Number: 1641891
• Product Code: MAL
• UDI-Device Identifier: 00384401018551
• UDI-Public: 00384401018551
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: 08/31/2020
• Device Model Number: M00202175824P0
• Device Catalogue Number: M00202175824P0
• Device Lot Number: 15J02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/16/2017
• 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