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

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

Patient Problems Reocclusion (1985); Patient Problem/Medical Problem (2688)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date article published online.Journal article title: endovascular treatment of femoro-popliteal lesions clinical cardiology.2019; 42: 175¿183.Wileyonlinelibrary.Com/journal/clc © 2018.Wiley periodicals, inc.Kansal a, long ca, patel mr, jones ws.Endovascular treatment of femoro-popliteal lesions.Clin cardiol.2019; 42: 175¿183.Https://do i.Org/10.1002/clc.23098.If information is provided in the future, a supplemental report will be issued.

Event Description

This review article aims to highlight the efficacy of various therapies including laser atherectomy, stent technology, and drug-coated balloons (dcb) over standard percutaneous transluminal angioplasty (pta) and gives insight into why they are being used and why variation exists.The article references various modalities and reviews studies including those which compare dcb vs pta, covered stents vs bare metal stents (bms), and atherectomy + dcb vs dcb alone.Within this review the following information is reported: dcb vs pta: from the inpact trial it is reported that clinically driven total lesion revascularization (cd-tlr) is 9.1% (dcb group) vs 28.3% (pta group).Primary patency (freedom from cd-tlr or restenosis) is reported as 78.9% (dcb) vs 50.1% (pta).Safety outcomes: freedom from 30-day device and procedure related death, major limb amputation, cd-tlr is reported as 87.4% (dcb) vs 69.8% (pta).From the pacifier trial it is reported that cd-tlr is 7.1% (dcb group) vs 27.9% (pta group).Primary patency (freedom from cd-tlr or restenosis) is reported as binary restenosis 8.6% (dcb) vs.32.4% (pta).Safety outcomes: freedom from 30-day device and procedure related death, major limb amputation, cd-tlr is reported as 7.1% (dcb) vs 34.9% (pta).Stent vs other technologies: the viastar trial compares the use of covered metal stent (cms) to a variety of bare metal stent (bms) including medtronic¿s protégé everflex.Cd-tlr is reported as 13.4% (cms) vs 23.0% (bms).Primary patency (freedom from cd-tlr or restenosis) is reported as 70.9% (cms) vs 55.1% (bms).Safety outcomes (freedom from 30 day device and procedure related death, major limb amputation) is not reported to have differed between the groups.Atherectomy vs other technologies: shammas et al.Compares medtronic¿s silverhawk directional atherectomy (da) device vs pta and reports cd-tlr as 8.0% (da) vs 22.2% (pta).Primary patency (freedom from cd-tlr or restenosis) is not reported within this; and safety outcomes (freedom from 30 day device and procedure related death, major limb amputation) is not reported to have differed between the groups.The definitive ar trial reports on atherectomy + dcb vs dcb alone and reports cd-tlr as 7.3% (da + dcb) vs 8.0% (dcb alone).Primary patency (freedom from cd-tlr or restenosis) 84.6% (da + dcb) vs 81.3% (dcb alone) and safety outcomes (freedom from 30 day device and procedure related death, major limb amputation) is reported as 89.3% da + dcb) vs 90.0% (dcb alone).

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8374168
• MDR Text Key: 137272549
• Report Number: 9612164-2019-00713
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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: 02/15/2019
• 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