MAUDE Adverse Event Report: MEDTRONIC IRELAND BTK TURBOHAWK; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problem Embolism/Embolus (4438)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'use of the directional atherectomy for the treatment of femoro-popliteal lesions in patients with critical lower limb ischemia'.The aim of the prospective study was to evaluate the safety and efficacy, at one year,of the directional atherectomy procedure and assess its impact on the procedural success of endovascular treatment for femoro-popliteal obstructive disease in patients with critical limb ischemia.From march 2012 to march 2013, 18 consecutive patients with critical limb ischemia underwent dca (turbohawktm plaque excision system) for treatment of femoro-popliteal obstructive disease.During the procedure a spider fx embolic protection was positioned distal to the stenosis.Filter size was chosen according to landing artery diameter.Dca was performed using the turbohawk¿ device; a monorail exchange system running over a 0.014¿ guidewire which was chosen out of the 7 diameters and catheter lengths available to treat the femoral, popliteal and below the knee vessels.Under fluoroscopic guidance we advanced the device across the lesions at a speed of 1-2 mm per second with the cutting blade in constant orientation against the eccentric plaque, thereby avoiding circular movements.The cutting sequence was repeated as necessary in order to excise the largest amount of plaque possible.Self-expanding nitinol stent implantation was permitted for bailout stenting (residual stenosis > 30% or flow limiting dissections).Lesion pre-dilation was left at operator¿s discretion.Dca was performed on all 18 patients with an ensuing technical success achieved in all cases (100%).No vessel perforation occurred.In no cases was bailout stent implantation necessary.Six (33.3%) diabetic patients with distal ulcers required additional tibial pta in order to ensure direct blood flow to the foot.Embolic material was evident at macroscopic inspection within the positioned filter in all of the cases thus demonstrating embolization of atherosclerotic debris.In only one case (5.6%) was the debris amount large enough to determine filter plugging.A normal antegrade flow was restored following filter recapture.No mace occurred in hospital and, consequently, procedural success was also achieved in 100 % of the cases.No deaths or major amputations occurred during follow-up.Limb salvage was achieved in all patients while two cases required minor toe amputation.One-year duplex scan assessment revealed no recurrent stenosis or occlusions in 15 of the patients, giving a primary patency of 83.3%.In one of patients an sfa reocclusion occurred at 6 months however no signs of cli recurrence were observed.Two other patients received femoro-popliteal below-the- knee bypass determining a secondary patency rate of 94.4% at 12 months.

Manufacturer Narrative

Ref: 2016 nov 1:15:42-47.Collection 2016nov a2:average age a3: majority sex.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.

• Brand Name: BTK TURBOHAWK
• 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: 18919054
• MDR Text Key: 337844180
• Report Number: 9612164-2024-01298
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• 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: 03/07/2024
• 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 Age: 68 YR
• Patient Sex: Male