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 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

The product involved in the reported event is not readily accessible for testing at the time of this mdr report.Indeed, we learned that due to internal regulations of the group of hospitals, the device cannot be returned immediately to the manufacturer.It has to be kept available for the local health authorities for a period of at least one month.We will again request for the product return once the retention period is over.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.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

It was reported to intervascular that when the cardioroot woven graft was removed from the package on the operating table, it showed a lesion of the internal collagen lining that flaked off into fragments with the only manipulation.The prosthesis was therefore not implanted on the patient and a similar one was used, which did not present the same problem.The surgery was not delayed, they took another cardioroot and went on.

Event Description

Complaint (b)(4).

Manufacturer Narrative

(10/213) the returned device was inspected by qa supervisors on 23-may-2022.Their observations are as follows: "the product arrived in its external box, opened, taped and damaged.No internal packaging was present (neither internal nor external blister).The ifu were present as well as the patient set (identification in conformity).The graft was placed in a biohazard zipper bag identified with a patient set label.The graft was completely crushed (see 605718 appendix 1).During observation, significant collagen detachment was observed at the bulb (see 605718 appendix 2).However, it was also observed that the prosthesis had been completely turned over.The prosthesis had been cut lengthwise.Inspection of the outside of the graft did not reveal any defects (see 605718 appendix 3).As is, the product could not have passed the qc step.Moreover, turning the prosthesis upside down does not allow us to determine the origin of the problem because it could have accentuated the phenomenon.The product is rejected physically and electronically".(4110/213) actual occurrence rate was calculated for similar events on the same manufacturing line (intergard/hemagard) for the period 1- june-2021 to 31-may-2022.The occurrence rate was 0.003%, which is below the anticipated occurrence rate (maximum) of 0.010%.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported event.Based on the visual inspection of the returned product, the cause of the event remains unknown since the condition of the returned device does not allow to determine the origin of the problem, as the handling of the device may have accentuated the phenomenon.

• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13964318
• MDR Text Key: 289897620
• Report Number: 1640201-2022-00012
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013921
• UDI-Public: (01)00384401013921
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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
• Device Operator: Health Professional
• Device Model Number: HEWROOT0032
• Device Catalogue Number: HEWROOT0032
• Device Lot Number: 22B17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 109 KG