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

Model Number	IGW0030-30
Medical Device Problem Codes	Material Frayed (1262); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was reported that the involved graft is available for testing, it should be returned to intervascular.(4121/3233) the review of the complaint device history records is ongoing, results are pending.(4109/213) the review of historical data indicated that no other similar complaint was reported for the sterilization lot number: 20j10.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that as soon as the surgical team opened the involved graft, they noticed it was shorter in length and had a thinner wall thickness.When they observed that shedding occurred while cutting the graft for use, they gave up using the product and opened another 30mm graft.Upon measuring both grafts, they found that the involved graft was 6¿7 cm shorter.
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
Corrected data: the block h6 the medical device problem code ¿1506¿ is updated and replaced by ¿1262¿.(10/213/4248) the involved device was returned in two fragments to intervascular for examination.A visual inspection was performed by the production supervisor and the quality assurance engineer, it concluded that the involved device is conform to the product dimensional specifications.In addition, the visual inspection showed that the ends of the graft displayed numerous loose fibers, suggesting that an inappropriate cutting tool may have been used, contrary to the instructions provided in the product¿s ifu.Indeed, the customer informed that ¿when they cut the graft to use it, they saw that there was shedding¿, therefore, the fraying issue appeared after cutting.(4121/213) the device history records review concludes that no deviation was identified in relation with the reported event.(67) based on the results of the visual inspection, it was concluded that the product is conform to the product dimensional specifications.Given that the product was cut by the customer, it is reasonable to assume that, on a complete uncut graft the original length of the product was within specification prior to cutting.To be noted that according to our procedures and in accordance with the applicable international standard iso 7198, the usable length of vascular grafts is measured when graft is stretched at a medium tension without completely eliminating the embossing rings.(19/4315) regarding to the reported fraying, the most likely root cause is linked to the use of an inappropriate cutting tool as according to the event description it was noticed when cutting the graft.However, this cannot be confirmed since no additional information was provided about the instrument used for cutting.Please note that the following mention is also present in the section directions for use of the product ifu: ¿as with all the woven products, the intergard woven vascular grafts should be cut with a low-temperature disposable cautery (e.G.900°f / 500°c) to minimize fraying.¿.

• 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: jessica hinostroza ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 21774492
• Report Number: 1640201-2025-0000007
• Device Sequence Number: 13302470
• Product Code: DSY
• UDI-Device Identifier: 00384401000266
• UDI-Public: (01)00384401000266
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 08/31/2025
• Device Model Number: IGW0030-30
• Device Catalogue Number: IGW0030-30
• Device Lot Number: 20J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown