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

Model Number	HEWROOT0028
Medical Device Problem Codes	Flaked (1246); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22g07.(4121/213) the device history records review concludes that no deviation was identified in relation with the reported event.(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(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 during the surgical procedure, when the cardioroot graft was going to be sewn in after cutting the neck area after the bulge, the surgeon noticed clumps of the graft coating peeling from the graft onto gloves.The graft was taken off the field and not implanted per surgeon decision.The procedure was slightly delayed to get another graft (a platinum 28mm straight graft) to finish surgery.No harm to the patient was reported.
Additional Manufacturer Narrative
(b)(4) the involved device was returned to intervascular for examination.A visual inspection of the involved device was performed by a trained quality control (qc) technician, a quality assurance (qa) engineer and the production supervisor on 25-feb-2025.The observation results of the inspection were reviewed by the qa supervisor on 21-march-2025, as follows: the visual inspection of the product confirmed the presence of a collagen peel-off.However, it was also found that the product had been handled and cut by the surgeon.The collar of the product on which the cut was made shows ¿fraying¿, suggesting that the cut was most likely made with an inappropriate tool, since according to instructions for use (ifu) of intergard woven grafts which is mentioned: "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.¿ it was also observed that the peel-off zone extends from the customer's cut-out to the top of the prosthesis bulge.This area is extensive and easily detectable.It should be noted that the body of the prosthesis is not affected by this peel-off problem, even if we try to induce it (stretching and internal rubbing of the prosthesis).Considering the condition of the returned graft, the product does not comply with product specifications.A lack of collagen was identified on part of the collar and bulge.Additionally, the presence of fraying caused by the customer's cutting was also observed.(b)(4) an analyze of the root cause, which could potentially explain the reported complaint, was performed by the qa supervisor based on the risk analysis of intergard standard products.The following root causes were analyzed: considering the peel-off observed during the visual inspection was so significant that it is unlikely that a trained and qualified qc technician would have allowed the product to pass in this conditions during the qc inspection.Additionally, no remarks were made by the customer regarding a defect on the product packaging, which could point to a problem during product transport (e.G., a severe shock, although this could hardly explain the peel-off observed on the product).The review of the product movements shows no atypical events during transport.The product thus reached the customer very shortly after its manufacturing (manufactured in july 2022 and delivered in september 2022).Finally, it appears highly likely that fraying caused by the customer's cutting of the collar may have led to the peel-off of the collagen.Indeed, the fraying of the thread associated with the handling of the prosthesis must have weakened the adhesion of the collagen to the prosthesis, thus causing a peel-off from the cut area up to the top of the bulge.(b)(4) the actual occurrence rates were calculated separately for both identified events (collagen peel-off and frayed graft) on the same manufacturing line (intergard/hemagard) for the period from 01-mars-2024 to 28-feb-2025.The occurrence rates were (b)(4) for the identified risks, which is below the anticipated occurrence rate (maximum) of (b)(4) in the product risk analysis.(b)(4) based on the investigation findings, no conclusion can be drawn on the exact origin of the reported incident.However the most likely root cause of the reported incident is the use of an inappropriate cutting tool to cut the prosthesis, causing fraying that weakened the collagen layer.To be noted that as per the product ifu of intergard woven grafts, the following warnings are stated: "care should be taken when handling the graft to avoid damaging the collagen coating." ¿due to their intrinsic weaving pattern, woven grafts are more prone to fraying.Do not cut woven grafts with scissors or scalpel to limit the risk of graft fraying.¿ moreover, 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.¿.
Event or Problem Description
Complaint # (b)(4).It was also reported to intervascular that the user is not a new user of cardioroots.The surgeon has never seen the same issue with the hemashield brand.Therefore, the surgeon decided to use a straight platinum hemashield graft with no issues.

• Brand Name: CARDIOROOT
• 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: 21282059
• Report Number: 1640201-2025-0000003
• Device Sequence Number: 21162304
• Product Code: DSY
• UDI-Device Identifier: 00384401013907
• UDI-Public: (01)00384401013907
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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 Model Number: HEWROOT0028
• Device Catalogue Number: HEWROOT0028
• Device Lot Number: 22G07
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 61 KG