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

Model Number	IGK1608
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4117) the device is not accessible for testing as it remained implanted in the patient.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22l03.(3331/213) a review of the complaint device history records has been performed, the results concluded that there was non-conformance/planned deviation in relation with the event reported.(4111/3233) there are insufficient information about the adverse event as well as the medical history of patient.More information about the adverse event has been requested to better understand it.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.4117 - the actual device involved in the adverse event remained implanted.
Event or Problem Description
It was reported to intervascular from the health facility that a porosity issue with the prosthesis occurred.They reported an ¿extreme porosity of the prosthetic left leg¿.The right leg was waterproof.It was decided to keep the prosthesis implanted because the proximal anastomosis had already been performed on the aorta.This is the first time this center encountered this issue.They associated this event with a potential risk of hemorrhage, a potential increase in the duration of the operation if the surgeon had to explant the graft and finally, increased risks on a fragile patient.
Additional Manufacturer Narrative
(11/213) two retention samples from the same sterilization lot number and with the same fabric type (knitted) were selected.An intergard knitted straight graft coated on the same date and with the same coating parameters as the involved device was selected to evaluate the collagen coating.Additionally, an intergard knitted bifurcated graft coated on a date close to that of the involved device was selected to evaluate the effect of graft's configuration.A visual inspection performed by a quality control technician and the quality assurance supervisor concluded that the products are in compliance with the specifications.Water permeability testing was also performed on the retention samples.The test results are within specification.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
Corrected data : on block h1, type of reportable event was corrected from serious injury to malfunction.Indeed, no additional information has been received from the initial reporter as of the date of this report, thus considering the event description initially reported, there is no evidence that the reported event meets the definition of a ¿serious injury¿ as defined in regulation.There was no indication that the situation was life threatening, caused permanent damage to the body function or permanent damage to the body structure nor necessitated medical or surgical measures to avoid permanent injury or impairment.(4111/3221) no additional information about the incident was obtained in spite of several attempts to contact the surgeon.In view of the lack of information from initial reporter, no further investigation can be performed (67) no conclusion can be drawn on the exact origin of reported event since the product remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: INTERGARD KNITTED BIFURCATED
• 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: 16501297
• Report Number: 1640201-2023-00006
• Device Sequence Number: 6259319
• Product Code: DSY
• UDI-Device Identifier: 00384401000488
• UDI-Public: (01)00384401000488
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2023

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 Model Number: IGK1608
• Device Catalogue Number: IGK1608
• Device Lot Number: 22L03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 05/05/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/19/2023; 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male