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

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

Patient Problems Stenosis (2263); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 08/06/2019

Event Type  Injury  

Event Description

Abstract introduction: the role of atherectomy (athero) for the treatment of symptomatic infra-inguinal arterial lesions remains controversial.We evaluated the effectiveness and safety of atherectomy-assisted endovascular interventions in comparison with percutaneous angioplasty (pta).Material and methods: a systematic search utilizing medline, embase and the cochrane central register of controlled trials was conducted for studies comparing athero with pta from february 1995 to may 2018.Only studies comparing athero to pta for symptomatic infra-inguinal disease were included.Random-effects meta-analysis was used to pool the data and endpoints across studies.Study endpoints included vessel dissection, distal embolization, residual stenosis (> 30%), vessel patency at 6 months, target lesion revascularization (tlr) at 12 months and major amputation rates at 1, 6, and 12 months.Results: a total of 2923 patients were included from 8 studies.Pta was associated with higher vessel dissection (or = 4.00, 95% ci: 1.15¿13.86) and lower 12-month major amputation rates (or = 0.73, 95% ci: 0.59¿0.90).There was no significant difference between athero and pta groups in terms of distal embolization (or = 0.45, 95% ci: 0.04¿4.63), residual stenosis (or = 1.28, 95% ci: 0.58¿2.80), vessel patency at 6 months(or = 1.27, 95% ci: 0.50¿3.22), tlr at 12 months (or = 1.07, 95% ci: 0.46¿2.51), or limb amputation at 1 month (or = 0.69, 95% ci: 0.44¿1.07) or 6 months (or = 1.54, 95% ci: 0.38¿6.15).Conclusions: in patients undergoing infra-inguinal endovascular interventions, pta was associated with higher peri-procedural vessel dissection and lower 12-month major amputation rates.Both modalities were associated with similar distal embolization, residual stenosis, and 6-month vessel patency and amputation rates.

Manufacturer Narrative

Literature title atherectomy-assisted versus percutaneous angioplasty interventions for treatment of symptomatic infra-inguinal peripheral arterial disease arch med sci atheroscler dis 2019; 4: e231¿e242 doi: https://doi.Org/10.5114/amsad.2019.89900 copyright © 2019 termedia banach a2 majorly 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.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: 18356119
• MDR Text Key: 330933869
• Report Number: 2183870-2023-00449
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 12/07/2023
• 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 Sex: Male