MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175926P0
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trackwise id # (b)(4).The device is manufactured by intervascular (b)(4).(b)(4) is the importer of the device.A follow up importer medical device report will be submitted once the results from the manufacturer are available.
Event or Problem Description
The doctor did the operation on (b)(6) 2019.During the operation, they used one hemashield 4b graft and found the connection between the graft body and these three branches was bleeding a lot.And then they used the autologous pericardium to mend the bleeding site.It took around 15 hours to do this operation because of the bleeding issue and therefore they delayed sternal closure for the edema.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9173731
• Report Number: 2242352-2019-01110
• Device Sequence Number: 2774458
• Product Code: MAL
• UDI-Device Identifier: 00384401018643
• UDI-Public: 00384401018643
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019
• Report Date (Section F): 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/31/2023
• Device Model Number: M00202175926P0
• Device Catalogue Number: M00202175926P0
• Device Lot Number: 18L07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2019
• 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
• Date Report Sent to FDA: 10/09/2019