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

Model Number HEWROOT0032

Device Problems Material Frayed (1262); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

(10/3233) a fragment of the involved product was returned to the manufacturer.A visual inspection will be performed.(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 22m08.(3331/3233) the device history records review is ongoing, results are pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

It was reporter to intervascular that, after making some adjustments to shape a cardioroot, the surgeon started putting suture to attach it and the suture tore through twice.It was indicated that the suture passed through the graft and the valve when the surgeon was tying it as usual, but the suture tore through the graft.The surgery was prolonged since they had to use a competitor's graft to resize and implant it to complete the case.There were no fragments left in the patient.No consequence was reported on the patient.The surgeon has previously used cardioroot twice before.

Manufacturer Narrative

(4111) blocks b5 was updated with additional information provided by the surgeon regarding the performed procedure and the instrument used.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(10/4248) a fragment of the device was returned to intervascular for inspection.Upon receipt, it was noticed that the graft has been cut at the level of the cardioroot bulge.A visual inspection performed by the quality assurance manager revealed that the product was not cut with a thermocautery as confirmed by the surgeon.Indeed, the constituent threads of the prosthesis are visible.To be noted that the following mention is present in the section directions for use of the current product instructions for use (ifu): ¿as with all the woven products, the intergard woven grafts should be cut with a low-temperature disposable cautery (e.G., ¿ 900°f / ¿ 500°c) to minimize fraying.¿ moreover, to be noted that the following mention is present as a warning in the ifu: "due to their intrinsic weaving pattern, woven grafts are more prone to fraying.Do not cut woven grafts with scissors or scalpels to limit the risk of graft fraying".Moreover, the product exhibits lacerations corresponding to the suture tear noticed by the surgeon.These lacerations may have been caused by the use of needles not recommended in the ifu.Please note that the following mention is present as a warning in the ifu: "use of taper cut or other cutting needles may damage the graft fibers." in conclusion, due to the product having been cut and weakened, it is not possible to determine the cause of the reported torn suture.(4112/3233) a medical assessment of the reported case will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).Additional information provided by the initial reporter indicates the surgeon performed a redo-redo root procedure and used scissors to cut the bulge of the cardioroot.No information about the instrument used for suturing was provided.

Manufacturer Narrative

(4112) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint is regarding a cardioroot woven graft.While passing the first stitch through the graft the suture ¿cut¿ through the fabric.This maneuver was performed a second time and again the suture ¿cut¿ through the graft.After the second attempt, the surgeon decided to switch devices and instead used a terumo valsalva graft.The result of this was a prolonged operative time.The consequence for the patient was considered a serious injury due to the possibility of the device having been implanted without the surgeon identifying the weakened fabric.The surgeon, using the cardioroot graft only for the second time, used scissors to shape the graft against the specific warning included in the ifu.Use of scissors not recommended due to the intrinsic weaving pattern of the fabric that makes it more susceptible to fraying.Instead, woven pet should be cut with a low temperature disposable cautery as specified instructions for use of the ifu.Also mentioned: cutting needles, excessive tension should be avoided; and needle bites should be greater than 2mm from the cutting edge.It was not confirmed that a cutting needle was used; or that excessive tension was applied; or that bites were taken inside of 2mm from the cut edge.A fragment of the device was returned for inspection; the threads of the device were observed as well as lacerations linked to suture tear.The narrative of the surgeon explaining the method used to cut the device together with the analysis of the sample provided are strongly indicative of the fabric tearing due to fraying." (61) the outcome of the conducted investigation suggests that the most probable root cause of the event would be the use of scissors to cut the woven graft instead of the recommended thermocautery outlined in the current product instructions for use (ifu).As highlighted in the medical review, the method used to cut the device together with the examination of the sample provided are strongly indicative of the fabric tearing due to fraying.To be noted that, due to their intrinsic weaving pattern, woven grafts are more prone to fraying.As indicated in the ifu, a low temperature disposable cautery should be used to minimize fraying when cutting this graft.In accordance with our complaint procedures, customer will be specifically informed of this ifu recommendation, via the complaint response sent to the customer, in order to prevent recurrence of the use error.

Event Description

Complaint #(b)(4).

• Brand Name: CARDIOROOT
• Type of Device: 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: 17711848
• MDR Text Key: 322973606
• Report Number: 1640201-2023-00028
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013921
• UDI-Public: (01)00384401013921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEWROOT0032
• Device Catalogue Number: HEWROOT0032
• Device Lot Number: 22M08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention