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

Model Number	IGKAX0808RS45/30
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remaining fragments of the involved device have 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 an iliac artery aneurysm surgery performed on (b)(6) 2016, it was reported that excessive blood leaking occurred from the part of the branch graft without rings.This bleeding occurred when declamping the graft after anastomosing the main segment with the patient vessel.The bleeding finally stopped by itself without any medical or surgical intervention and the surgery was completed.The patient was reported as being fine.
Additional Manufacturer Narrative
Remaining fragments of the involved device were 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, signs of cut and holes 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 KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5972525
• Report Number: 1640201-2016-00025
• Device Sequence Number: 671807
• Product Code: DSY
• UDI-Device Identifier: 00384401000877
• UDI-Public: 00384401000877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964625
• 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): 08/26/2016

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: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: IGKAX0808RS45/30
• Device Catalogue Number: IGKAX0808RS45/30
• Device Lot Number: 15E28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 11/30/2016
• 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: Other