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

Model Number	IGK1608
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual inspection of the bifurcation segment under magnifying lamp was performed by both operators and supervisor in charge of the sewing and inspection of the crotch area.No anomaly was found, the sewing was confirmed to be compliant with the acceptation criteria.Two remaining fragments of the involved device were returned for examination and they were sent to an external and independent laboratory.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned fragments 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 collagen material infiltration with no significant abnormality such as tears, loss of textile cohesion, holes and signs of cut at the bifurcation segment.The sem analysis corroborated the macroscopic analysis.No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective.
Event or Problem Description
During an abdominal aortic aneurysm surgery performed on (b)(6) 2016, blood leak was noted from the bifurcation of the main segment.Blood spots were oozing from the graft but it is unknown how much blood leaked.The product was stretched during surgery.The graft was removed and replaced by a igk1407 graft to complete the surgery.The surgery was finished with no adverse effect on the patient.
Additional Manufacturer Narrative
A visual inspection of the bifurcation segment under magnifying lamp was performed by both operators and supervisor in charge of the sewing and inspection of the crotch area.No anomaly was found, the sewing was confirmed to be compliant with the acceptation criteria.Two remaining fragments of the involved device were returned for examination and they were sent to an external and independent laboratory.The objective of the study was to evaluate the presence of any structural abnormality visible on the external side of the returned fragments 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 collagen material infiltration with no significant abnormality such as tears, loss of textile cohesion, holes and signs of cut at the bifurcation segment.The sem analysis corroborated the macroscopic analysis.No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product 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: 6124756
• Report Number: 1640201-2016-00035
• Device Sequence Number: 19082244
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: 00384401000488
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 15E21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 07/04/2017
• 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