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 Embolism (1829); Fistula (1862); Occlusion (1984); Perforation (2001); Pseudoaneurysm (2605)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

Average age, majority gender.Event date is literature article published date directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency circulation: cardiovascular interventions (2017) 10; pg 1-12 doi: 10.1161/circinterventions.116.00484.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to discuss the definitive ar study which is a prospective, multicenter, randomized controlled pilot trial designed to assess and estimate the safety and the effect of treating vessels with directional atherectomy (da) before drug-coated balloons (dcb) angioplasty (da+dcb) as compared with dcb angioplasty alone to facilitate the development of future randomized studies.One hundred two patients with claudication or rest pain were randomly assigned 1:1 to da+dcb (n=48) or dcb alone (n=54), and 19 additional patients with severely calcified lesions were treated with da+dcb.Of the total 121 patients, they were split as follows: da+dcb ¿ 48 patients ¿ silverhawk and turbohawk device(s); dcb ¿ 54 patients; nonrandomized (nr) da+dcb ¿ 19 patients ¿ only treated with turbohawk.Majority of lesions were de novo lesions in all groups.For patients treated with da devices, spider fx filter for distal embolic protection was used (85.4%).Target lesion location for the da+dcb & nr da+dcb groups is as follows: proximal sfa (4 patients), mid sfa (40 patients), distal sfa and popliteal (23 patients).The most common procedural complications for the da+dcb & nr da+dcb groups combined are: arterial perforation (2 patients), arteriovenous fistula (3 patients), dissection¿grade c/d or greater (1 patient), distal embolism (4 patients), pseudoaneurysm (4 patients).Both perforations were treated with prolonged pta, however per protocol, treatment with dcb was not allowed after the perforations.Study assessments occurred at baseline, procedure, pre-discharge, 30 days, 6 months, and 1 year after the study procedure.The primary outcome was angiographically defined as the target lesion percent diameter stenosis at 1 year post procedure, defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the angiographic core laboratory.Major adverse events (mae¿s) were defined as major unplanned amputation of the treated limb, all-cause mortality, or clinically driven tlr.There were 3 clinically driven tlr's reported at 1 year in the da+dcb group.No clinically driven tlr's were reported at 2 years follow-up in the nr da+dcb group.There were 2 deaths in the da+dcb group and 1 death in the nr da+dcb but it has been reported that none of the deaths were attributed to the study devices or procedure.It was concluded that da+dcb treatment was effective and safe.

• 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: 7036246
• MDR Text Key: 92143029
• Report Number: 2183870-2017-00505
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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: 10/16/2017
• 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: 70 YR