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

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

Patient Problems Hematoma (1884); Reocclusion (1985); Perforation (2001); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Date of event: date of publication journal name: ann vasc surg 2020; -: 1¿10 title of article: directional atherectomy of the common femoral artery: complications and outcomes literature reference: 10.1016/j.Avsg.2020.01.094.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature article, directional atherectomy of the common femoral artery: complications and outcomes, , that patients participated in a study between july 2017 and december 2018 that the use of directional atherectomy (da) with or without drug-coated balloon (dcb) may be considered for the management of common femoral artery (cfa) occlusive disease because of its minimally invasive nature with early mobilization, reduced incision complications, and infection rates.Hawkone, spider fx and in.Pact admiral devices were used in the study.A total of 25 patients underwent common femoral artery directional atherectomy of which 2 had an occluded cfa, and 23 had >70% cfa stenosis as determined by ultrasound scan (uss) and/or computed tomography angiogram (cta) preoperatively.Hawkone and spider fx devices were used in all cases.In.Pact admiral devices were used where there was a residual stenosis >50% after atherectomy.There were no deaths within 30 days.Procedure-related complications included 2 cases of cfa pseudoaneurysm (one of them repaired by open surgery) and 1 cfa perforation (repaired with covered stent).No distal embolization or limb loss occurred.One pseudoaneurysm 12 hr after the procedure and 1 cfa bleeding during atherectomy.There was 1 death from a myocardial infarct, which was not procedure related.Ten patients reached 12 months of follow-up.Nine had a patent atherectomized cfa with no significant restenosis.There were no major amputations or deaths.

Manufacturer Narrative

Additional information: the author confirmed that the complications mentioned in this journal article are not device related.If information is provided in the future, a supplemental report will be issued.

• 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: 9932198
• MDR Text Key: 196553728
• Report Number: 9612164-2020-01484
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161361
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• 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: 03/16/2020
• 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
• Patient Age: 77 YR