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

Model Number	IGW0028-30
Medical Device Problem Codes	Flaked (1246); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular that when an intergard woven straight graft 28cm x 30cm was prepared for use, the customer noticed that it was not suitable for use due to the color change observed on the graft.Moreover, it was reported that particles in the graft were spilled.The customer wanted to prevent the spillage by cutting a portion of it.However, the particles continued to fall out from the cut parts.
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for visual inspection.(4109/3233) the review of historical data indicated that one other complaint was reported for the same sterilization lot number 20e14.Current case investigation is ongoing.An update will be sent upon investigation to state on the similarity of the issue.(3331/213) the device history records review concluded that there was no non conformance/planned deviation in relation with the event.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.Evaluation anticipated but not yet begun.
Additional Manufacturer Narrative
Corrected data: on block h6, the medical device problem code "1246" was removed following the testing results of involved device as described below.(10/213) the involved device was returned to intervascular.A visual inspection was performed by two quality control (qc) technicians.The observation results were analyzed by the quality assurance supervisor, who concluded that there is an excess of collagen on the graft, which is acceptable in regard to the product specifications as it does not present an excess thickness or risk of detachment.Moreover, a stained appearance was observed throughout the length of the product, which is linked to the collagen and is acceptable within product specifications.Therefore, the product was in compliance with the current acceptance and rejection standards applied during the qc inspection.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20e14.(67) the conducted investigation concludes that the returned product is in compliance with the specifications.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: INTERGARD WOVEN STRAIGTHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 16992485
• Report Number: 1640201-2023-00014
• Device Sequence Number: 20599889
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: (01)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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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: 04/30/2025
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 20E14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown