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

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

Patient Problems Aneurysm (1708); Perforation (2001); Stenosis (2263); Embolism/Embolus (4438)

Event Date 03/13/2020

Event Type  Injury  

Event Description

Abstract background: endovascular therapy is the first-line strategy for femoropopliteal obstructive disease.However, for lesions involving the common femoral artery (cfa) surgical endarterectomy is still the gold standard.Aims: the aim of this study was to evaluate the safety and efficacy of directional atherectomy (da) for the treatment of cfa lesions.Methods: a retrospective analysis of patients who underwent da of the cfa between (b)(6) 2009 and (b)(6) 2017 was performed.The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdtlr).Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (abi), and rutherford-becker class (rbc) during follow-up.Results: this analysis included 250 patients.The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months).The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26).All but one complication could be treated conservatively or endovascularly.One surgical revision was necessary.Freedom from major adverse events (death, cdtlr, myocardial infarction and major target limb amputation) at 30 days was 99.6%.The rate of cdtlr during follow-up was 13.6% (n=34).A significant improvement of the mean abi and the rbc was observed.Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdtlr.Conclusions: the use of da for the treatment of cfa lesions leads to promising midterm results with an acceptable complication rate.

Manufacturer Narrative

Literature title: outcomes of directional atherectomy for common femoral artery disease eurointervention 2021;17:260-266 © europa digital <(>&<)> publishing 2021.All rights reserved a2 average age a3 majority gender b3 date of acceptance 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.

• 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: 18475416
• MDR Text Key: 332440939
• Report Number: 2183870-2024-00011
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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: 01/04/2024
• 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: 70 YR
• Patient Sex: Male