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

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

Patient Problem Occlusion (1984)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This article aims to evaluate the frequency of primary obstruction events (pro) during one-year follow-up after performing excisional atherectomy with the silverhawk/turbohawk atherectomy device s/th or remote superficial femoral artery endarterectomy (rsfae) in patients with the chronic superficial femoral artery occlusive disease (sfaod).All randomized clinical trials (rcts) and not-rcts concerning the treatment of patients with sfaod after s/th and rsfae without duration.27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis.The results of 2762 patients¿ treatment were evaluated.Primary obstruction events (pro) reported were restenosis and occlusion during one-year follow-up with target lesion revascularization carried out to treat the restenosis and occlusion.The article reports 792 out of 2762 people experienced pro.The study concluded that s/th with the spiderfx device (distal embolic protection) are safe and effective treatment option for short lesion (15 cm) in patients with sfaod, rsfae may be considered better than an endovascular procedure.

Manufacturer Narrative

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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9670539
• MDR Text Key: 177966961
• Report Number: 9612164-2020-00568
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2020
• 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