MAUDE Adverse Event Report: COVIDIEN SPIDER FX

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

Patient Problems Perforation (2001); 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 inf arct, 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.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: SPIDER FX
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9932201
• MDR Text Key: 196814915
• Report Number: 2183870-2020-00100
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K063204
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR