MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problems Intimal Dissection (1333); Embolism (1829); Reocclusion (1985); Patient Problem/Medical Problem (2688)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: average age.Sex: majority gender.Event date is literature article published date.Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for common femoral artery atherosclerotic disease journal of endovascular therapy (2017) 0;1-8 doi.Org/10.1177/1526602817748319.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this article is to report the experience using directional atherectomy (da) with antirestenotic therapy (daart) in the form of drug-coated balloon (dcb) angioplasty vs dcb angioplasty alone in common femoral artery (cfa) occlusive lesions.Dcb¿s used included in.Pact admiral and in.Pact pacific balloons.Directional atherectomy devices used included the hawkone and turbohawk with the choice being at the discretion of the interventionalist.Spider fx distal protection devices were also used in daart group patients and was positioned in the sfa if it was patent; otherwise, the deep femoral artery was selected.This is a single center retrospective study on the 47 consecutive patients treated between 2001-2016.Patients were divided into two groups: daart (21 patients) <(>&<)> dcb (26 patients).Most lesions were restenotic and only 4 lesions were chronic total occlusions (all in the daart group).Mean lesion length, vessel calcification, and severity of calcium burden were comparable between the groups.In the daart group, directional atherectomy was used to reduce the plaque burden of the target lesion at least 50% while the procedure goal was to achieve a <(><<)>30% residual restenosis by visual estimation.Adjunctive dcb therapy was applied in all cases.The dcb was inflated with complete lesion coverage for 180 seconds.Bailout stenting, vessel perforation, access site complications, and distal embolization were the early reported outcomes.Flow-limiting dissections were treated using prolonged dilation; bailout stenting was applied only in cases of persistent major dissections or recoil.The reported distal embolism was aspirated.The access site complications included 2 false aneurysms requiring surgical treatment following dcb angioplasty and 3 hematomas.Median follow-up time was 16 months.No aneurysmal degeneration of the treated vessels was observed during follow-up.In follow-up, 5 daart patients died (3 of unknown causes and 2 of multiple organ dysfunction syndromes).None of the deaths was considered procedure-related.1 daart patient underwent major amputation of the index limb due to uncontrolled skin infection.Among the 4 reinterventions performed in the daart group, 2 were repeat daart, 1 had a supera stent implanted to treat a calcified reocclusion, and the last patient had dcb angioplasty alone.Flow-limiting dissection or residual stenosis >50% was treated with repeated prolonged (>2 minutes) balloon inflation with an uncoated balloon.Provisional (bailout) stenting with a self-expanding nitinol bare stent was used to treat major flow-limiting dissections or recoils.In the dcb angioplasty group, vessel preparation with balloon dilation was performed prior to dcb angioplasty in all cases using a standard uncoated balloon inflated to a diameter 1 mm less than the selected dcb catheter.Adjunctive dcb therapy was then applied from healthy-to-healthy vessel; the paclitaxel-coated balloon selection was at the discretion of the treating interventionist.In the event of deep femoral artery disease requiring treatment, dcb angioplasty of the distal cfa/proximal sfa and of the deep femoral artery was performed using a kissing balloon technique.Technical success was achieved in 88% of patients in the dcb group.Bailout stenting, vessel perforation, access site complications were the early reported outcomes.Bailout stenting was applied only in cases of persistent major dissections or recoil.The access site complications included 2 false aneurysms requiring surgical treatment following dcb angioplasty and 2 hematomas.Flow-limiting dissection or residual stenosis >50% was treated with repeated prolonged (>2 minutes) balloon inflation with an uncoated balloon.Provisional (bailout) stenting with a self-expanding nitinol bare stent was used to treat majorflow-limiting dissections or recoils.In follow-up, 1 dcb patient succumbed to acute coronary syndrome.2 dcb patients underwent major amputation of the index limb due to uncontrolled skin infections/ among the reinterventions performed, 3 dcb patients underwent surgical endarterectomy, 1 had a repeat dcb angioplasty.

• Brand Name: HAWKONE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7269118
• MDR Text Key: 99996545
• Report Number: 2183870-2018-00084
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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: 01/15/2018
• 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
• Patient Age: 71 YR