MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD KNITTED AXILLO-BIFEMORAL RADIALLY SUPPORTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGKAX100808RS35/20

Device Problem Use of Device Problem (1670)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

(10/3233) it was reported that a fragment of the graft that was not implanted in the patient is available.It will be returned for inspection.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 23e04.(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.

Event Description

It was reported to intervascular that during an axillo bi-femoral bypass procedure, the graft was sewn in at the top end and then the surgeon injected saline solution to test the anastomoses before securing at the bottom end.The surgeon noticed leaking in several places.Additional information provided by the initial reporter indicates that they had suture the top and the axillary and was testing the anastomoses; one side of the graft was fine but the side branch leak was unusual which the surgeon believed was excessive.The surgery was not delayed since the leaking part was removed and replaced by an albo polyester graft 40cm length by 8mm width.The surgeon has over 20 years of experience and has often used intergard products.He has always performed the procedure in the same way and has never noticed this before.There was no harm or injury to the patient.

Manufacturer Narrative

(10/213) a fragment of the involved device was returned to intervascular for examination.Two visual inspections of the returned product were performed, the first inspection was carried out in the presence of a trained quality control (qc) technician, the production and quality assurance (qa) supervisors, and the second inspection was in presence of the textile engineer and the qa supervisor.The observation results concluded that, the fragment corresponds to a cut section of the axillo rs branch.No anomalies including structural defects were observed on the returned fragment.(67) the conducted investigation concludes that the returned product fragment is in compliance with the product specifications.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

(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.

Event Description

Complaint (b)(4).

• Brand Name: INTERGARD KNITTED AXILLO-BIFEMORAL RADIALLY SUPPORTED
• 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: 17816706
• MDR Text Key: 324239621
• Report Number: 1640201-2023-00029
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401006039
• UDI-Public: 00384401006039
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964625
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGKAX100808RS35/20
• Device Catalogue Number: IGKAX100808RS35/20
• Device Lot Number: 23E04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male