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

Model Number	IGK0010-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The (10/3317/213) 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.The (3340/3345/213) 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 sent upon completion of the investigation.
Event or Problem Description
During a cardiac surgery, it was reported a diffuse and strong bleeding from the graft wall, through all length, after implantation.The bleeding could not be stopped.The graft was explanted and another one was implanted.No additional information could be obtained at the date of this report.
Additional Manufacturer Narrative
A piece of the graft was returned for examination.It was sent to an external and independent laboratory, it should be noted that this fragment was stored in a surgical glove from the date of the surgery until it was sent to the 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 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).The sem analysis pointed out a massive and heterogeneous collagen material infiltration through the textile structure.The heterogeneous pattern of the collagen (disrupted collagen material) was likely related to the poor storage conditions of the prosthesis before receipt at the laboratory for analysis.No significant abnormality such as tears, loss of textile cohesion, holes and signs of cut were observed.The sem analysis corroborated the macroscopic analysis.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 KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6056807
• Report Number: 1640201-2016-00032
• Device Sequence Number: 19073132
• Product Code: DSY
• UDI-Device Identifier: 00384401000389
• UDI-Public: 00384401000389
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2016

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: 06/30/2018
• Device Model Number: IGK0010-40
• Device Catalogue Number: IGK0010-40
• Device Lot Number: 13G18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 03/13/2017
• 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: Required Intervention