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

Catalog Number UNK-PLY-HAWKONE

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

Patient Problems Aneurysm (1708); Reocclusion (1985); Stenosis (2263)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Date of event = date of article publication."directional atherectomy with antirestenotic therapy for the treatment of no-stenting zones." the journal of cardiovascular surgery 2019 april; 60 (2): 198-204, doi: 10.23736/s0021-9509.19.10866-x.If information is provided in the future, a supplemental report will be issued.

Event Description

This article discusses previous studies on the effect of drug coated balloon (dcb) as an adjunct therapy to directional atherectomy (da) for femoropopliteal bending zones to ensure patient to be free from restenosis, and also reports on the use of da and antirestenotic therapy (daart) for treatment of the common artery.The article also refers to the use of embolic protection devices when using da devices.Directional atherectomy for the popliteal artery.The article references the use of daart in the definitive le trial and talon registry and reports it was associated with a higher primary patency rate compared with dcb angioplasty for isolated popliteal lesions.Medtronic hawkone da device were used in these trials.Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of daart and dcb, respectively.Aneurysm formation has been reported after directional atherectomy or dcb angioplasty in the femoropopliteal vessels, as well as after drug-eluting stent placement in the coronary vessels.The overall 30-day aneurysm formation rate was 0.5% in the definitive le trial and 0.6% in the talon registry.A possible explanation for this aneurysm formation is a synergic action of paclitaxel and directional atherectomy.The article reports that minor injuries of the arterial wall during plaque excision could increase the toxicity of paclitaxel.In any case, avoiding deep injury to the adventitial layer during directional atherectomy remains crucial.Hopefully, devices with optical coherence tomography could minimize the risk of vessel injury.Daart for common artery the article reports on a recent study comprising of 30 patients which aimed to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of common femoral artery (cfa) obstructions with daart.All patients presented with severely calcified obstructions of the common femoral artery were treated using da (including hawkone da device) followed by dcb dilatation.Provisional stenting was allowed in the case of a suboptimal result.Twenty cases (66%) were isolated cfa interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively.Chronic total cfa occlusions (cto) were recanalised in six cases (20%).Procedural success was achieved in all cases; stenting was needed in three cases (10%).At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively.The secondary patency rate was 96.7%.Percutaneous embolic protection devices and da the article reports on the use of the spiderfx embolic protection from the 2008 protect study comprising of 40 patients who underwent treatment with angioplasty/stenting or atherectomy, and an embolic protection device.Outcomes report macroembolization occurred in 55% of cases, and macrodebris at least 2 mm in diameter occurred in 45% of cases, mostly among patients undergoing atherectomy.

• Brand Name: HAWKONE
• 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: 8518600
• MDR Text Key: 142199662
• Report Number: 9612164-2019-01358
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161361
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-HAWKONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• 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