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

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

Patient Problems Myocardial Infarction (1969); Restenosis (4576)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Procedural and clinical outcomes with catheter-based plaque excision in critical limb lschemia.J endovasc ther 2006;13: 12-22 © 2006 by the international society of endovascular specialists available at www.Jevt.Org a2 average age a3 majority gender b3 date of publication.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 examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (cu).Methods: between (b)(6) 2003 and (b)(6) 2004, a prospective evaluation was conducted of consecutive patients with cu (rutherford category 2:5) who were treated with endovascular plaque excision at 7 institutions.This study enrolled 69 patients (37 women; mean age 70±12 years, range 43-(b)(6)) with cu involving 76 limbs.Clinical outcomes were prospectively followed for 6 months.The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days.Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed.Results: procedural success was achieved in (b)(4) of cases.Major adverse events occurred in (b)(4) of patients at 30 days and (b)(4) at 6 months.The target lesion revascularization rate was (b)(4), and there were no unplanned limb amputations.Amputation was less extensive than initially planned or avoided altogether in (b)(4) of patients at 30 days and (b)(4) at 6 months.Conclusion: catheter-based plaque excision is a safe and effective revascularization method for patients with cu.These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in cui silverhawk plaque excision system ((b)(6) technologies, (b)(6), ca, usa) used there was no device-related perforation, embolization, or major bleeding.The single failure involved a patient who developed subacute thrombotic occlusion 1 day following revascularization, requiring repeat target lesion revascularization (tlr) with balloon angioplasty purpose: to examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (cu).Methods: between (b)(6) 2003 and (b)(6) 2004, a prospective evaluation was conducted of consecutive patients with cu (rutherford category 2:5) who were treated with endovascular plaque excision at 7 institutions.This study enrolled 69 patients (37 women; mean age 70±12 years, range 43-93) with cu involving 76 limbs.Clinical outcomes were prospectively followed for 6 months.The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days.Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed.Results: procedural success was achieved in (b)(4) of cases.Major adverse events occurred in (b)(4) of patients at 30 days and (b)(4) at 6 months.The target lesion revascularization rate was (b)(4), and there were no unplanned limb amputations.Amputation was less extensive than initially planned or avoided altogether in (b)(4) of patients at 30 days and (b)(4) at 6 months.Conclusion: catheter-based plaque excision is a safe and effective revascularization method for patients with cu.These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in cui clinical follow-up was performed for all patients through 6 months following the index procedure.At 30 days, there was no death.Ml, or unplanned amputation (table 4).Partial or complete healing of ulcerated tissue was observed in (b)(4) limbs (fig.2).(b)(4) patients underwent planned amputation.By 6 months, however, (b)(4) patients had died, (b)(4) patients had undergone repeat tvr, and there was a single documented ml ((b)(4)).Tlr occurred in 5 ((b)(4)) of 160 lesions.Among the 48 limbs in which amputation was planned prior to the plaque excision procedure, amputation was avoided altogether in 39 limbs at 30 days and 32 limbs at 6 months (relative reductions, (b)(4) and (b)(4)).Over the entire study period, 16 ((b)(4)) patients underwent planned amputation, with 3 patients having undergone prior segmental amputation followed by planned full extent amputation.By 6 months, no unplanned amputations occurred, and 2 patients underwent a less ex tensive amputation than planned before the index procedure.Thus, amputation was less extensive than initially planned or avoided altogether in (b)(4) of limbs at 30 days and (b)(4) at 6 months.Clinical outcomes did not significantly differ relative to revascularization site(s) or whether plaque excision was performed with or without adjunctive stenting or angioplasty (table 5).Further, comparing patients with and without diabetes mellitus, no significant differences at 6 months were observed regarding tlr ((b)(4) diabetes versus (b)(4) no diabetes, p =(b)(4)), amputation ((b)(4) diabetes versus (b)(4) no diabetes, p= (b)(4)), or major adverse events ((b)(4) diabetes versus (b)(4)no diabetes, p=(b)(4)).

• 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: 18362560
• MDR Text Key: 330933016
• Report Number: 2183870-2023-00454
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 12/13/2023
• 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: 70 YR
• Patient Sex: Female