MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problems Myocardial Contusion (1763); Reocclusion (1985)

Event Date 05/25/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date of publication.Journal article title: combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results 1553-8389/$ ¿ see front matter © 2012 elsevier inc.All rights reserved.Doi:10.1016/j.Carrev.2012.04.007 220 a.Cioppa et al./ cardiovascular revascularization medicine 13 (2012) 219¿223.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: the use of directional atherectomy (da) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate.Drug coated balloons (dcb) reduced restenosis rate in non heavy calcified lesions.Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using da and dcb for the treatment of heavy calcified lesions of the femoro-popliteal tract.Methods: from january 2010 to november 2010, 240 patients underwent pta of the femoro-popliteal tract in our institution.Within this cohort a total of 30 patients had life limiting claudication (llc) (n= 18) and 12 a critical limb ischemia (cli) with baseline rutherford class 4.2± 1.2 underwent pta of heavy calcified lesions with intravascular ultrasound guided da and dcb.All procedures have been performed using a distal protection device.Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis>50%) by visual estimation.After the intervention patients were followed up to 12 months.Results: procedural and clinical success, was achieved in all cases.Bail-out stenting was necessary in only two (6.5%).Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation.Duplex control was performed in all the cases (n= 30).In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (tlr= 10%) leading a total one-year secondary patency rate of 100%.All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure.Conclusion: the data suggest that combined use of da and dcb may represent a potential alternative strategy for the treatment of fem oro-popliteal severely calcified lesions.These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9304856
• MDR Text Key: 170661685
• Report Number: 2183870-2019-00534
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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: 10/15/2019
• 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
• Patient Age: 68 YR