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

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

On block b3 and d6b, the event date and explanted date indicated are (b)(6) 2015 as we only known the year of the graft explantation.On block d4, please note that the exact product model is unknown however it is known that the diameter of the graft is 8mm.Please note that the article mentioned 4 intergard grafts in total, of which one was already handled as a complaint in 2019 (complaint (b)(4)).Two other emdrs will be reported in parallel related to this article.(4117) the prosthesis was explanted in (b)(6) 2015 and directly sent by the explanting surgeon to an external laboratory for analysis (gepromed).(4111/3233) as part of the complaint handling, the author was contacted in order to get more details about the case.Only limited information was provided, including the surgeon's contact details.A list of questions will be sent to the surgeon in order to better understand the adverse event and get more information about the patient status and graft identification (serial and batch numbers).(4118) at this time of investigation, there is not enough information to start the investigation.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.H3 other text : 4117 - the prosthesis was explanted in (b)(6) 2015 and directly sent by the explanting surgeon to the external and independent laboratory (gepromed).

Event Description

This is a case report from literature of infection after more than 8 years of implantation of an intergard / hemagard graft.The diameter of the graft is 8 mm.The reference of the article is the following: degradation phenomena on last generations of polyethylene terephthalate knitted vascular prostheses doi: (b)(6).The web address location for the article is the following: https://www.Sciencedirect.Com/science/article/pii/s2666350323000019?ref=pdf_download&fr=rr-2&rr=7d6300c82e5d3cec the article was initially published on february 23, 2023.Complaint #837319.

Manufacturer Narrative

(4111/3121) as part of the investigation, several attempts were made to establish contact with the surgeon.These attempts were undertaken with the aim of clarifying the incident and acquiring additional details regarding the patient's condition.Regrettably, despite these diligent efforts, no information was forthcoming from the surgeon.(4119/3221) no product identifier (i.E.Serial number, sterilization lot number or product reference) was provided, therefore, the device history record review, the historical data analysis and the retention sample analysis could not be carried out.(4112/3221) the case has been reviewed by the medical affairs department whose assessment is below: "this complaint was generated after the publication by bellisard et al was discovered during an annual literature review.A multicenter retrospective study was performed looking at 19 explanted pet grafts.The study was published describing the non anastomotic degradation of pet grafts.In this publication there were 3 different complications described; thrombosis, pseudo-aneurysm, and infection.The surgeons that explanted the grafts were contacted with a series of additional questions, but there was no response.The publication describes ¿intrinsic textile structure phenomena¿ and anatomic constraints as the cause for the non anastomotic rupture.Due to the lack of information it is not possible to speculate what might be the cause of these events.What is not clear is if these complications have been submitted for review and addressed by intervascular previously at the time the surgeons explanted the grafts." (4315) based on above elements and due to the lack of information it is not possible to conclude on the exact origin of the adverse event reported within the article.(22) moreover, please note that infection is an undesirable side-effect as indicated in the current instructions for use.

Event Description

Complaint #(b)(4).

• Brand Name: INTERGARD KNITTED
• 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: 17167629
• MDR Text Key: 317630355
• Report Number: 2242352-2023-00498
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2023
• Distributor Facility Aware Date: 09/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention