MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGW0028-30

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

10/3233: it was reported that the product is available for investigation, it should be returned to intervascular for examination.3331/213: the device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.4109/213: the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20e14.4102/213: one retention sample from another sterilization lot number (20e07) was selected based on the following criteria: it was coated on the same day and under similar conditions as the involved device.Moreover, it is a woven device with a reference similar to the one of the product involved.This retention sample was visually inspected by the quality assurance supervisor.Neither internal visual defect, nor external was found.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #:(b)(4).Patient taken for bental procedure and graft taken, and inspected for usage.It was found that the coating in the graft is peeling off, near the suture area, and on the inside of the graft.Surgery completed by using new 28 mm graft.Customer confirmed that the delay of surgery was not clinically significant, and patient remained stable with no adverse consequences.

Manufacturer Narrative

(10-4112/3221) : the involved product was returned to intervascular and was inspected by the quality assurance supervisor.Below are the main elements of the inspection results: product arrived cut in 2 pieces.By inspecting one of the 2 pieces, an area whiter than the entire product is observed, which looks like a detachment of the collagen layer.As a result, the product is non-compliant.The photo sent by the customer was also analyzed by the qa supervisor.The main observation result is that the area, where the collagen has been removed, has been turned over entirely.It is noticeable because the color of the reference line is either darker, either lighter.As a final result, it was concluded that may be a defect ¿lack of adhesion of the collagen layer¿ was present during the inspection performed by the surgeon prior to use, and that the surgeon has may be manipulated the product to see it better, which would explain the fact that he completely turned the product over.The turnaround made by the user has then caused a total detachment of the collagen layer.However, due to the actual condition of the returned product, it is not possible to rule out any more on the compliance to specification at the time of manufacturing and to clearly identify the type of problem.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported event.An internal non-conformity report has been initiated in order to evaluate the root cause and take appropriate corrective actions if necessary.

Event Description

See initial mfr report 1640201-2020-00027.Complaint #(b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11029142
• MDR Text Key: 222788333
• Report Number: 1640201-2020-00027
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: 00384401000242
• Combination Product (y/n): N
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 20E14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 78