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

Model Number	M00202175432P0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During replacement of aorta ascending and hemiarch, it was reported that a blood leaking occurred.The amount of blood loss was approximately 500 ml intraoperatively.The bleeding was stopped by wrapping the graft with tachosil and administration of blood products.A blood transfusion was required.The surgery was prolonged due to the time needed to stop the bleeding.The patient was reported to be stable, planned for rehabilitation.
Additional Manufacturer Narrative
A remaining fragment of the involved device was available for investigation.It was sent to an external and independent laboratory for examination.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned vascular graft fragment and to evaluate the presence of collagen material.The analysis consisted of a macroscopic observation of the fragment and a scanning electron microscopy (sem) analysis.The sem analysis pointed out an abundant infiltration of collagen material with no obvious 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: 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: 6976435
• Report Number: 1640201-2017-00033
• Device Sequence Number: 16433361
• Product Code: MAL
• UDI-Device Identifier: 00384401018261
• UDI-Public: 00384401018261
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/25/2017

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: 01/31/2022
• Device Model Number: M00202175432P0
• Device Catalogue Number: M00202175432P0
• Device Lot Number: 17B15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 03/05/2018
• 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: Required Intervention