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

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

Patient Problems Aneurysm (1708); Thrombus (2101); Pseudoaneurysm (2605)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A patient underwent peripheral angiography for progressive short distance claudication of 20 metres.On physical examination, the patient had no tissue loss, no palpable pedal pulses, and weak distal pulses detected using a hand held doppler device.Angiography revealed 90% stenosis in the left common iliac artery (cia) and 70% stenosis in the left superficial femoral artery (sfa).Left cia and sfa angioplasties were performed to good angiographic results and symptomatic relief for the patient.A follow up ultrasound 6 months after left cia and sfa angioplasty revealed recurrent left sfa stenosis of 80% and no recurrent flow limiting lesion of the cia.Despite being compliant with best medical therapy, the patient once again reported symptoms of short distance claudication which started about 2 months after previous procedure.Left sfa intervention was initiated via percutaneous peripheral angiogram.After anticoagulation with heparin, the lesion was crossed with a non-medtronic glide wire with catheter support.Contrast injection through the catheter confirmed positioning in the true lumen.A spider fx embolic protection device was delivered distal to the lesion.Atherectomy was performed with a turbohawk lx-c device followed by balloon angioplasty with a 5.0mm x 60mm drug eluting balloon.Completion angiogram showed satisfactory results with no dissection flap or contrast extravasation.Puncture site was closed with a non-medtronic device.The patient was discharged home after an uneventful overnight period of observation, with no peri procedural complications.6 weeks post atherectomy, a routine follow up ultrasound revealed an asymptomatic 25x25mm aneurysm with mural thrombus in the left sfa.At this point, a decision was made to manage the aneurysm conservatively, with an interval scan in 3 months.The patient was lost to follow up despite multiple phone calls and appointment reminders via email.The patient was referred back to the clinic 2.5 years later with pain and mild swelling in the left thigh.Angiography showed a saccular pseudoaneurysm of the mid left sfa measuring 50x43x40 mm.Percutaneous angiography confirmed these findings.A 7f sheath was inserted to the left via the right groin, a fine wire was used to cross the lesion which was stented with a 6.0x60mm non-medtronic stent and post dilated to 6mm.Completion angiogram showed successful exclusion of the aneurysm.No complications were associated with the procedure and the patient was discharged home the next day.Doppler ultrasound a month later showed patency of the sfa stent and a thrombosed saccular aneurysm measuring 50x44x40mm with no endoleak.Delayed pseudoaneurysm development in the treated segment of the sfa was most likely due to inadvertent atherectomy of disease-free intima proximal and distal to the target lesion, despite the correct use of an appropriately sized atherectomy device.The combination of a weakened arterial wall and high shear force from adjacent blood flow could have led to a weakened and dilated arterial lumen.

Manufacturer Narrative

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: ATK TURBOHAWK CALCIUM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9982565
• MDR Text Key: 190925780
• Report Number: 2183870-2020-00121
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K111723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR