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

Model Number	IGW0032-15
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint device history records indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.Please note that water permeability testing is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.One retention sample coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).A remaining fragment of the involved device was returned for examination and was sent to an external and independent laboratory.The objective of the study is to evaluate the presence of any structural abnormality visible on the external side of the remaining fragment and to evaluate the presence of collagen material.The analysis consists of a macroscopic observation of the fragment and a scanning electron microscopy (sem).The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
During a surgery performed on (b)(6) 2017, a blood leaking occurred.It was reported that when putting in place the graft, the surgeon noticed that the graft was permeable (unusual behaviour).The surgeon had to use a substantial amount of surgicel (hemostatic agent) to stop the bleeding.The haemostasis was difficult to control.The product remained implanted.No clinical consequence for the patient was reported.
Additional Manufacturer Narrative
((b)(4)) a remaining fragment of the involved device was returned for examination and it was 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 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 heterogeneous presence of collagen material infiltration without abnormality such as tears, loss of textile cohesion, holes and signs of cut.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 WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6636906
• Report Number: 1640201-2017-00019
• Device Sequence Number: 555916
• Product Code: DSY
• UDI-Device Identifier: 00384401000273
• UDI-Public: 00384401000273
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 12/31/2021
• Device Model Number: IGW0032-15
• Device Catalogue Number: IGW0032-15
• Device Lot Number: 17A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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