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

Model Number	IGW0026-15
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/05/2017
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 day 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.No conclusion can be drawn.However, all information and the product testing performed would tend to indicate that the device was not defective.
Event or Problem Description
It was reported that on (b)(6) 2017, a severe bloodloss occured through the wall of the prosthesis during an aortic ascenda with hemiarch procedure.The bleeding was stopped by applying hemostatic agents (gelita x-sorb ) and administration of coagulation drug (octaplex - 2 doses), the surgery was significantly prolonged and blood transfusion was required.The graft remained implanted, the patient stayed 4 days at icu.No consequence for patient was reported.
Event or Problem Description
Additional information provided by the distributor indicated that during the visit to the surgeon who reported the bleeding complaint, the surgeon mentioned that he perceived the graft as lighter in color and more rigid by touch than usual.
Additional Manufacturer Narrative
(b)(4).Additional information related to the visual characteristics perceived by the surgeon have been shared with the medical affairs.Upon this review, and as an extreme precaution, it has been verified with the distributor that storage conditions are well controlled and maintained according to the product instructions for use.In addition, the graft has been shipped to the hospital together with other similar grafts from the same lot number which have been implanted without any reported issue.The conducted investigation would tend to indicate that the product was not defective.

• Brand Name: INTERGARD WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7160015
• Report Number: 1640201-2018-00001
• Device Sequence Number: 16495722
• Product Code: DSY
• UDI-Device Identifier: 00384401000211
• UDI-Public: 00384401000211
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K984294
• 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): 04/20/2018

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: 05/31/2022
• Device Model Number: IGW0026-15
• Device Catalogue Number: IGW0026-15
• Device Lot Number: 17F08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTICOAGULANTS, HEPARIN, ANTIBIOTICS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 82