This is one of ten manufacturer reports being submitted for this case.The dates of the events are unknown; however, according to the article the study period was from january 2014 and june 2019.For this reason, the first day of the reported study period (01-january 2014) was used as the occurrence date.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.Per the instructions for use (ifu), vessel injury is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive as related patient and procedural information were not provided.However, the event is likely related to the mechanism described above.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Article citation: michel jm, frangieh ah, giacoppo d, alvarez-covarrubias ha, pellegrini c, rheude t, deutsch o, mayr np, rumpf pm, stahli be, kastrati a, schunkert h, xhepa e, joner m, kasel am.Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves.Clin res cardiol.2021 dec;110(12):1993-2006.Doi: 10.1007/s00392-021-01935-7.Epub 2021 sep 9.Pmid: 34505192.Article reporting, devices not returned.
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As reported by our affiliates in (b)(4), through the review of the medical article: "safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves", corresponding author a.Markus kasel from klinik fur herz- und kreislauferkrankungen of the german heart center in munich.743 patients with native aortic valve disease treated at the klinik fur herz- und kreislauferkrankungen of the german heart center in munich, germany, between january 2014 and june 2019, in a single-strategy standardized minimalist setting using the sapien 3 thv via the transfemoral route were evaluated.The following events were identified: major vascular complication (cumulative from procedural to 30 day): 62 patients (57 with tricuspid leaflet, 5 with bicuspid leaflet).
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Additional report to provide that this is one of ten manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691- 2022- 05467, 2015691- 2022- 05470, 2015691- 2022- 05471, 2015691- 2022- 05473, 2015691- 2022- 05474, 2015691- 2022- 05476, 2015691- 2022- 05478, 2015691- 2022- 05479, and 2015691- 2022- 05481.
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