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

Model Number IGK1608

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 10/25/2016

Event Type  Injury  

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 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.

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
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6124756
• MDR Text Key: 60825128
• Report Number: 1640201-2016-00035
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: 00384401000488
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention