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

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

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 11/15/2010

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'clinical and haemodynamic evolution of lesions treated by means of atherectomy with silverhawk in the femoropopliteal sector '.The article reports on a prospective study performed over 12 months with 19 patients with femoropopliteal arterial lesions treated by atherectomy between (b)(6) 2008 and (b)(6) 2009.The silverhawk device was used for the atherectomy.The atherectomies were performed in the operating theatre by a vascular surgeon by means of anterograde homolateral femoral access.Data were obtained on the device, and different-sized devices ¿ ms, ll or lx ¿ were used, according to the diameter of the vessel to be treated; and the use of the distal filter, the criteria for the use of the filter were on plaques that were more susceptible to emboly and when the patient presented poor distal aperture.A balloon angioplasty and/or stent placement was performed in the same operation when significant residual stenosis was observed (>30%).The ms device was used in 12 cases, ls in 6 and lx in 1; the distal filter was used in 6 cases and a nitinol stent was placed in 5.Contrast extravasation arose as a complication in 2 patients, requiring the implantation of an covered stent and the performance of a femoropopliteal bypass in each one of the cases for arterial repair.Patients were monitored after 1, 3, 6 and 12 months post procedure.After 1 year, 7 patients (36.8%) were symptom-free, 2 of them required amputation below the knee and another one presented thrombosis of the superficial femoral artery on the ecodoppler, 5 (26.3%) mild-moderate intermittent claudication and 1 patient (5.3%) localised distal trophic lesion.It was observed that in the course of the controls, there is a tendency towards a reduction in the arterial lumen at all the arterial levels monitored.An extremity salvage rate of 79% after one year was obtained (fig.5), four major amputations were performed, a more distal amputation was performed in 2 of them, preserving the knee, thanks to the good outcome of the atherectomy of the superficial femoral artery; and a primary permeability of 58% after one year.Monitoring with ecodoppler showed occlusion of the superficial femoral artery in 3 patients, 2 of them in the control after 12 months, one case was resolved with balloon angioplasty, and the other did not require surgical treatment as the patient remained symptom-free, and the third occurred 9 months after the operation, requiring revascularisation by means of femoropopliteal bypass, obtaining secondary permeability of 62% after one year.

Manufacturer Narrative

Ref: doi:10.1016/j.Ejrad.2011.01.018 a2: average age a3: majority sex medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SILVERHAWK ATK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18957681
• MDR Text Key: 338305655
• Report Number: 9612164-2024-01398
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• 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