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

Model Number	IGW0028-30
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
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 similar complaint was reported for the same sterilization lot number 24a04.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(4118/3233) the type of investigation has not yet been determined.It is ongoing.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.The graft remained implanted.
Event or Problem Description
It was reported to intervascular that an intergard woven prothesis was implanted during an aortic dissection surgery performed on (b)(6) 2024.The prosthesis was implanted although the diameter of the prosthesis measured was greater (32 mm) than that indicated on the packaging (28 mm).The hospital reported that this did not cause a problem, and there was no harm to the patient.The hospital is accustomed to using these prostheses and this is the first time this has happened.
Additional Manufacturer Narrative
Corrected data: on block h6, problem code "1318" has been updated to "4051" based on the investigation results described below.Additional manufacturer narrative: (3331/4245) a non-conformity report was opened in order to investigate and determine the root cause.A thorough review of the manufacturing data was conducted.The investigation concluded that a potential product inversion at the time of primary packaging can be considered.However, it is not possible to confirm this hypothesis and pursue the investigation further since no examination of the product could be performed as it remained implanted.Moreover, as of today, the hypothetically corresponding inverted product has been implanted with no complaint being reported regarding a mislabeling issue.(25/4315) the investigation concluded that it was not possible to identify the exact origin of the graft diameter mismatch reported by the customer.The conducted investigation concluded that the most probable hypothesis is a potential product inversion at the time of primary packaging, however, this cannot be confirmed as the device was not available for examination.
Event or Problem Description
Complaint #: (b)(4).

• Brand Name: INTERGARD WOVEN STRAIGHT GRAFT
• 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: 19584852
• Report Number: 1640201-2024-00009
• Device Sequence Number: 17020662
• Product Code: DSY
• UDI-Device Identifier: 00384401000242
• UDI-Public: (01)00384401000242
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 24A04
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown