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

Model Number	HEWROOT0030
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) a fragment of the device was available and returned to intervascular.The examination of the fragment will be performed.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 23c30.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(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 the cardioroot was cut in two parts and when using the distal part of the prosthesis for wrapping, the surgeon noticed the presence of debris and intra-prosthetic fragments resembling collagen with embolism risk.The wrapping was done nevertheless.Additional information received from the initial reporter indicates that the issue was noticed during a tirone david procedure when the involved fragment was opened to wrap the distal (extra-vascular) anastomosis.No defects were observed on the implanted fragment.The surgery was not delayed and no consequences were reported on the patient.Moreover, the surgeon is not a new user of cardioroot.
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, according to the information received from the initial reporter the reported event does not meet the definition of a ¿serious injury¿ as described in the 21 cfr part 803.3.Actually, it did not result in life-threatening illness or injury or in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.(10/4248) a fragment of the involved device was returned to intervascular for examination.A visual inspection was performed by the quality assurance (qa) supervisor, the observation results are as follows: ¿collagen fragments were noticed in two different locations.Indeed, it is observed that the collagen layer has detached from the prosthesis and retracted forming aggregates of collagen.Consequently, there are areas without collagen (non-bright white spots).In this condition, the involved product would have been declared non-compliant in regard to the current list of acceptance and rejection standards applied during the quality control inspection.Considering the product was manipulated, it cannot be excluded that the collagen detachment may be due to product handling.¿.(19/4315) based on the investigation findings, no conclusion can be drawn on the exact origin of the reported collagen peel-off.The result of visual inspection indicates that the cardioroot was handled and cut by the customer.Considering the product was manipulated, it cannot be excluded that the collagen detachment may be due to product handling.Therefore, it is not possible to determine the root cause of the reported event.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.

• 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: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 18610832
• Report Number: 2242352-2024-00077
• Device Sequence Number: 7416811
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: (01)00384401013914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Importer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024
• Report Date (Section F): 02/15/2024

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: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 23C30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/15/2024