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

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

Patient Problems Pain (1994); Injury (2348)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Journal article title: directional atherectomy of the common femoral artery: complications and outcomes annals of vascular surgery 1-10 2020 volume 71, number 3 10.1016/j.Avsg.2020.01.094.If information is provided in the future, a supplemental report will be issued.

Event Description

From the literature article: patient initially presented with rest pain.Patient had a previous endovascular aneurysm repair (evar).Spiderfx embolic protection device was used routinely in all cases and placed in the superficial femoral artery (sfa).In-pact admiral angioplasty was used when drug-coated balloon (dcb) was used in conjunction with directional atherectomy (da).An open left brachial artery approach was used, and common femoral artery (cfa) da and dcb was performed with the hawkone directional atherectomy catheter.Coralline plaque was seen on the posterior wall of the cfa along with diffuse calcification throughout.There were no complications during the procedure.Completion angiography showed a good result with all vessels patent, no significant stenosis, and no pseudoaneurysm or contrast extravasation.Twenty-four hours later, the patient developed ipsilateral groin pain.Ultrasound scan (uss) showed a 13-mm dilatation of the cfa.It was managed conservatively.At 1 month, duplex uss showed a 16-mm cfa dilatation with no change in shape.The pain had resolved, but the patient could feel the pulsatile mass that was causing him severe anxiety.Cta showed dilatation in the anterior wall suggesting that routine 4 quadrant passes of the atherectomy catheter may not be appropriate where disease is eccentric but rather tailoring the passes to plaque location to avoid overtreating relatively healthier sections of the wall.Open surgical repair with great saphenous vein interposition graft was performed as the quality of the remaining artery was poor.Reimplantation of the profunda femoral artery (pfa) was also performed.There were no postoperative complications, and the patient remains asymptomatic.

Manufacturer Narrative

Additional information: the author confirmed that the complications mentioned in this journal article are not device related.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: HAWKONE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9948222
• MDR Text Key: 189743852
• Report Number: 9612164-2020-01546
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR