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

Model Number	IGW0028-30
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other complaint for collagen pell-off was reported for the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.A retention sample from same sterilization lot and coated on same period and under same conditions as the involved device was visually inspected by our qa supervisor.No collagen peel-off was found.The retention sample also underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).It was reported that the product is available for investigation, it should be returned to intervascular for examination.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
(b)(4).After the graft opened on the table during surgery, the doctor determined that the collagen structure was peeling.
Additional Manufacturer Narrative
((10/170) the involved product was returned to intervascular and was inspected by the quality assurance supervisor for evaluation.Below are the main elements of the inspection results: returned product arrived cut in two pieces.One piece was flipped (reference line was visible inside the product instead of outside).Some areas, whiter than the rest of the product, were similar to a detachment of the collagen layer.As the product has been manipulated before return, it must have resulted in a significant increase of a potential defect that could have been similar to defects found in our list of rejection and acceptance standards: excess of collagen or lack of collagen.If the defect was as marked as on the returned product, the operator would have rejected the product, during our qc, so we assume that the manipulation performed on the actual device that consisted of flipping the graft has degraded the collagen layer.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported event because the product has been manipulated before return to intervascular.However, it is confirmed that the product does not comply with the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
See initial mfr report # 1640201-2020-00004.Complaint (b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9733412
• Report Number: 1640201-2020-00004
• Device Sequence Number: 19607522
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: 00384401000242
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 19A24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1