MAUDE Adverse Event Report: COVIDIEN SILVERHAWK ATK; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Renal Failure (2041); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

Literature title endovascular management as first therapy for chronic total occlusion of the lower extremity arteries: comparison of balloon angioplasty, stenting, and directional atherectomy j endovasc ther 2011;18:624¿637 2011 by the international society of endovascular specialists a2 - average age a3 - majority gender b3 - date article presented medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Purpose: to evaluate the role of endovascular therapy in the management of infrainguinal arterial chronic total occlusions (ctos).Methods: data on all patients with ctos treated at a single center from 2004 to 2010 were extracted from a prospectively maintained database for retrospective analysis.Patient demographics, angiographic studies, noninvasive vascular test results, and clinical outcomes were evaluated.In this time frame, 481 patients (283 men; mean age 71.7611.5 years, range 52¿85) with claudication (n5177) or critical limb ischemia (cli, n5304) were treated for 688 ctos.Lesions were segregated according to location [sfa (n5193), popliteal (n567), tibial (n5217), and multilevel (n5211)] and analyzed based on treatment mode (angioplasty, angioplasty with stenting, or atherectomy) and clinical indication.Primary patency, assisted primary patency, and secondary patency, as well as limb salvage rates for cli patients, were calculated.Results: at 2 years in claudicants with ctos confined to the sfa, primary patency ranged from 44% to 58% and secondary patency to 92% depending on treatment type; there were no significant differences among the treatments.However, in cli patients with sfa ctos, atherectomy produced better outcomes at 2 years (p50.002 for primary and p50.012 for secondary patency) than angioplasty alone.The limb salvage rates ranged from 73% to 91% (no differences among treatment types).In diabetics, ctos treated with angioplasty and stent had improved secondary patency rates over angioplasty alone.Conclusion: the endovascular management of cto results in reasonable primary patency; moreover, secondary patency at 2 years is excellent.Endovascular therapy should be the first-line option for many patients with peripheral artery disease, including those with cli, claudicants with poor bypass conduit, or patients at high medical risk for surgery.The presence of ctos does not appear to change these recommendations.Although multiple reinterventions may be required, endovascular therapies can be considered a primary therapy for many patients with cto.

• Brand Name: SILVERHAWK ATK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18777604
• MDR Text Key: 336210513
• Report Number: 2183870-2024-00066
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male