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

Model Number HEWROOT0032

Device Problem Flaked (1246)

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

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

On july 27, 2021, an acknowledgment has been sent to the company representative in order to obtain more information about the event description.We expected following information: patient information, operation delayed, impact on the patient health status.On july 31, 2021 we learned that the patient was not harmed.Two additional attempts has been sent on the august 6, and august 10, 2021.It was reported on 22 july, 2021 that the product is available for investigation; it is in the process of being returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Dr.(b)(6) was attempting to insert cardioroot woven item# hewroot0032, s/n (b)(4) during the process when he noticed thats is was peeling from the edges he immediately removed the graft and replace with a hemashield graft 34 x 30 currently i have the graft in my office wrap in plastic for further investigation.We learned that the patient was not harmed.Complaint # (b)(4).

Manufacturer Narrative

Corrected data: on block b2, other was replaced by "required intervention".Indeed, during the surgical procedure, the graft was removed and replaced by another graft.On block h6, the code 2199 was replaced by code 4624.Indeed, during the surgical procedure, the graft was removed and replaced by another graft, so we consider that one or more surgical procedures was required, or an existing procedure changed.Additional narrative: (10/170) the involved product was returned to intervascular and was visually inspected by our quality assurance (qa) department.The main results are as follows: the external and internal lids of the product blister were opened.There is a coating defect, which suggests a collagen peel-off.If the surgeon found himself with "pieces of prosthesis on his hands", this information is consistent with this.On the cause of this phenomenon, several possible explanations.The cause should be handling of the product by the operating room team or a manufacturing defect.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported event because the product has been manipulated before return to intervascular.However, it is confirmed that the product does not comply with the specification.Therefore, a non-conformity report has been initiated in order to investigate the potential causes and take appropriate corrective actions if necessary.Please note that, as per instruction for use, care should be taken when handling the graft to avoid damaging the collagen coating.

Event Description

See initial mfg report # : 1640201-2021-00027 (complaint #(b)(4).Additional information was received on september 10, 2021 regarding the event: "small pieces of the graft was coming off on the surgeon's hand." "the surgery was delayed shortly while they grab another graft".

• 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
• MDR Report Key: 12334103
• MDR Text Key: 267038414
• Report Number: 2242352-2021-00675
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013921
• UDI-Public: (01)00384401013921
• Combination Product (y/n): N
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 20M24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Distributor Facility Aware Date: 08/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Date Manufacturer Received: 08/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention