MAUDE Adverse Event Report: INTERVASCULAR SAS PLATINUM WOVEN ANGLED AA 4B; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175728AP0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	01/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that we do not have the exact reference of the implanted prosthesis and that we have selected the reference that is closest to it.The product was most likely implanted in 2017, however the exact day and month are unknown.For that reason, we have deliberately set a date of (b)(6) 2017.Device is not accessible as it remained implanted in the patient.An attempt to contact the author will be made in order to obtain more information on the event.A medical review will be performed based on the article and the additional information requested.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Remained implanted.
Event or Problem Description
This is a case report from literature of a 71-year-old female patient with behcet's disease who had received repeated surgical aortic repairs presented with a complicated pseudoaneurysm.It developed not on the native aorta, but on the ascending aortic graft.It was positioned just beside the os of the attached trifurcated vascular graft trunk connecting arch vessels.To avoid reopening the sternum, which would have been fatal, coil embolization was successfully performed.This case suggests that transcatheter coil embolization might provide an alternative treatment option for such patients with a high risk of surgical mortality.The reference of the article is the following: kim ch, so yh, ok yj, choi j-s.Bail-out coil embolization for a pseudoaneurysm of aortic sinotubular junction in a patient with behcet's disease after receiving multiple aortic operations.J card surg.2022;37: 1410-1412.Doi:10.1111/jocs.16304 the web address location for the article is the following:https://pubmed.Ncbi.Nlm.Nih.Gov/35148443/.The article was initially published on janvier 23, 2022.
Additional Manufacturer Narrative
Corrected data : on block "h6 " the medical device problem code "3190" was updated to "2993".(4111) on oct-26-2022 we received few information about the case from dr.(b)(6)i, corresponding author in the paper.See below the resume: "dr.(b)(6) is still a resident and currently away from seeing patients and dr.(b)(6) was the only available doctor we could reach out to.We¿ve received a few images as well.So in summary: patient didn¿t have pseudoaneurysm when surgery was performed in (b)(6), 2016.It was found in 2021, shown in the ct scan.Pseudoaneurysm happened to be on the same site where the graft had worn out.He wrote about it just because it seemed rare.This looks like this is all we could get unfortunately.Hope this helps.Thank you so much." (4112/213) the case was reviewed by the corporate medical department whose assessment is below: "the complaint is taken from a case study published detailing a patient¿s surgical procedures resulting in the coil embolization of a pseudoaneurysm.The case study describes a 71 yo female patient with a 20-year history of behcet¿s disease and expanding aortic arch aneurysm (51mm) repaired (in 2016) by way of a type ii hybrid thoracic endovascular aortic repair using a 28 mm hemashield graft for the ascending aorta and a hemashield trifurcated graft for the innominate, left axillary and left common carotid artery bypasses.A gore tag endoprosthesis with a landing on the (replaced) ascending aortic graft was implanted.The post operative period (after discharge) was complicated with delayed mediastinitis which was managed with an omental flap repair.Four years later, the patient experienced a recurrent xanthogranuloma of the sternal wound and underwent adjuvant radiotherapy.Mri suggested that the granuloma may be originating from the peri-ascending aortic region, prompting reoperation.An aortic rupture occurred during re-sternotomy.The rupture site was noted on the proximal portion of the native aortic arch tissue which had been anastomosed to the proximal hemashield graft which replaced the ascending aorta.At this site was a portion of the stent graft which had potentially worn through the dacron prosthesis.This area was repaired with a dacron patch.Post operative period was complicated by a cerebral infarction.Two months later, the patient experienced dizziness, and subsequent ct angiography showed a pseudoaneurysm above the previous sino-tubular junction.A successful exclusion of the pseudoaneurysm was performed with coils.A ct scan performed 3 days later and again at 3 months post-embolization revealed no interval change.Steroid use was reinitiated per rheumatologist orders.The paper states: pseudoaneurysm can develop after surgical treatment of thoracic aortic aneurysms.Patients with behcet¿s disease have a higher risk of developing pseudoaneurysm than the general population.Pseudoaneurysms developed on the dacron aortic graft.The wearing of the native aortic tissue can be inferred to be related to vasculitis, however, there was no clear evidence to link the inflammatory process in behcet¿s disease to the dacron fabric tear.All getinge grafts are routinely tested prior to sterilization (visually inspected qc, air tested, and again by qc for packaging).After sterilization, samples from each sterilization lot are tested for water permeability and probe burst strength testing is completed on a monthly basis.As this graft passed all in-house testing, it is possible that the pseudoaneurysm may be due to one and/or more causes: a prolonged period of xanthogranuloma inflammation, radiation, instrumentation at time of placement of the gore tag device and the complex surgical dissection (incremented the likelihood of the possibility of this happening).It is reasonable to suspect that any of the manipulations which the aorta/graft went through may have contributed to the pseudoaneurysm.It should also be considered that the off-label use of the hemashield graft with the deployment of a gore tag device (which was not designed to have a stent placed inside of it) may have also contributed to the pseudoaneurysm.After this off-label use, there is evidence of wear on the graft described by the reoperation required to patch an area where a portion of the stent ¿popped out¿.The surgeon was unavailable for additional details of the procedure and the part or lot numbers are unknown, therefore retention samples cannot be tested.Based on the limited information in this complex case and without knowing vital details regarding the implantation of dacron grafts and stent, it is reasonable to conclude that the cause of the pseudoaneurysm formation is likely multifactorial.Some of these factors include but are not limited to the patient¿s vasculitis, steroid use, radiotherapy received and possible inflammatory process.In addition, several aspects may have contributed to the pseudoaneurysm including the multiple complex procedures (causing manipulation of graft and anastomosis) such as the ruptured area of the native aorta requiring patch repair, and the off-label use of one of the hemashield grafts (with a gore tag device implanted within the graft)." (4315) the investigation findings concluded that the it is reasonable to conclude that the cause of the pseudoaneurysm formation is likely multifactorial.(22) please note that pseudoaneurysm is an undesirable side effect as indicated in the current instructions for use: "potential complications which may occur in conjunction with the use of any vascular prosthesis include thrombosis, embolic events, occlusion and stenosis, intimal hyperplasia which could cause recurrent symptoms, infection, sepsis, perigraft fluid, seroma formation, bleeding, hematoma, fever, inflammatory reaction, pseudoaneurysm, anastomotic aneurysm, stroke, dilatation of the prosthesis, anastomotic disruption or tearing of the suture line and/or host vessel.A potential for a slight immunological reaction, evidenced by a slight rise in body temperature, may be associated with all collagen coated vascular products.".
Event or Problem Description
Complaint #(b)(4).

• Brand Name: PLATINUM WOVEN ANGLED AA 4B
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• 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: 15422624
• Report Number: 2242352-2022-00785
• Device Sequence Number: 6609443
• Product Code: MAL
• UDI-Device Identifier: 00384401018728
• UDI-Public: (01)00384401018728
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00202175728AP0
• Device Catalogue Number: M00202175728AP0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/11/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/16/2022