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

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

Patient Problems Embolism (1829); Stenosis (2263); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

Study title: debulking atherectomy in the peripheral arteries: is there a role and what is the evidence? konstantinos katsanos, stavros spiliopoulos, lazaros reppas, dimitris karnabatidis cardiovasc intervent radiol (2017) 40:964-977 doi: 10.1007/s00270-017-1649-6.Date of event: date of publication of article.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

The journal article explores the use of atherectomy in peripheral artery therapy.Several studies are called out in the article, the first of which comparing primary balloon angioplasty versus silverhawk directional atherectomy with balloon atherectomy in 58 patients suffering from intermittent claudication or critical limb ischemia.During follow-up, tlr, tvr and macro embolisation were seen.The second study investigates directional atherectomy with silverhawk in 601 patients.Procedural success was almost 98% with target lesion revasc necessary in approx 10% of patients over the follow up period.Another study looked at the effectiveness of if the silverhawk device in a total of 800 patients.During follow up saw 5% of patients requiring major unplanned amputations, embolisation occurred in 4%, perforation occurred in 5%, vessel occlusion in 2% and stenting required in 3% of patients.A study investigating silverhawk use in femoropopliteal lesions in 84 patients saw six distal embolisation events over the course of the study.A study of 30 patients with severely calcified sfa lesions that were treated under filter protection using the turbohawk system followed by in.Pact admiral drug-eluting balloons.While no procedure-related adverse events took place, bailout stenting was necessary in 7% of patients.Finally, a controlled study sponsored by medtronic compared upfront atherectomy with turbohawk or silverhawk devices followed by drug -eluting balloon angioplasty versus drug-eluting balloons alone.Dissection occurred in 2% of cases and bailout stenting was required in certain cases.One year restenosis also occurred in some cases.

• Brand Name: ATK TURBOHAWK CALCIUM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6767107
• MDR Text Key: 81820229
• Report Number: 2183870-2017-00333
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K061188
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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: 07/07/2017
• 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