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

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

Patient Problems Pain (1994); Vasoconstriction (2126); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 12/01/2009

Event Type  Injury  

Manufacturer Narrative

Literature title is atherectomy the best first-line therapy for limb salvage in patients with critical limb ischemia? vasc endovascular surg.2009 december ; 43(6): 542¿550.Doi:10.1177/1538574409334825.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

Objective¿to determine the efficacy of atherectomy for limb salvage compared with open bypass in patients with critical limb ischemia.Methods¿(b)(4) consecutive bypass and atherectomy procedures performed for critical limb ischemia between (b)(6) 2003 and (b)(6) 2006 were reviewed.Results¿a total of (b)(4) lesions were treated with surgical bypass in (b)(4).Bypass and atherectomy achieved similar 1-year primary patency (b)(4).However, the 1-year limb salvage rate was greater in the bypass group (b)(4).In the tissue loss subgroup, there was a greater limb salvage rate for bypass patients versus atherectomy (b)(4).Conclusions¿patients with critical limb ischemia may do better with open bypass compared with atherectomy as first-line therapy for limb salvage.

• Brand Name: SILVERHAWK BTK
• 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: 18362358
• MDR Text Key: 330934109
• Report Number: 2183870-2023-00453
• 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: 12/11/2023
• 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: 69 YR
• Patient Sex: Female