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

Model Number	IGW0030-15
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One remaining fragment of the involved device has been sent to an outside laboratory for macroscopic and scanning electron microscopy analysis.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 period 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.The investigation is still on going.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During a cardiac surgery performed on (b)(6) 2016, blood leaking was noticed from the graft after anastomose, which required the administration of 2 bags of thrombocytes.The hemostasis was performed and the graft remained implanted.The surgery was prolonged by about 1 hour.The patient was reported as doing well.
Additional Manufacturer Narrative
(b)(4).The remaining fragment of the involved device was analysed by an outside and independent laboratory.It consisted of a macroscopic examination and a scanning electron microscopy analysis.The laboratory concluded that no significant abnormality such as tears, loss of textile cohesion, holes and signs of cut were observed.The sem analysis corroborated the macroscopic analysis.The sem analysis pointed out presence of collagen material infiltration.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: 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: 5972615
• Report Number: 1640201-2016-00024
• Device Sequence Number: 16297827
• Product Code: DSY
• UDI-Device Identifier: 00384401000259
• UDI-Public: 00384401000259
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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: 03/31/2021
• Device Model Number: IGW0030-15
• Device Catalogue Number: IGW0030-15
• Device Lot Number: 16D21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 12/07/2016
• 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