INTERVASCULAR SAS INTERGARD KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Pseudoaneurysm (2605)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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On block b3 and d6b, the event date and explanted date indicated are (b)(6) 2020 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 know that the diameter of the explanted graft is 10mm.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 related to this article.(4117) the prosthesis was explanted in 2020 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 explanting 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 2020 and directly sent by the explanting surgeon to the external and independent laboratory (gepromed).
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Event Description
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This is a case report from the literature concerning a pseudoaneurysm potentially related to a nonastomic rupture after about 13 years of implantation of an intergard knitted graft.After implantation, the diameter of the product is approximately 10 mm.The diameter before implantation is unknown.The reference of the article is the following: "degradation phenomena on last generations of polyethylene terephthalate knitted vascular prostheses" doi: https://doi.Org/10.1016/j.Jvssci.2023.01.001 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 #: (b)(4).
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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(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 pseudoaneurysm is an undesirable side-effect as indicated in the current instructions for use.
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