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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Pulmonary Embolism (1498); Bradycardia (1751); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Stenosis (2263)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Title: endovascular treatment for near occlusion of the internal carotid artery: 30-day outcome and long-term follow-up journal: clinical neuroradiology doi 10.1007/s00062-016-0546-8 clin neuroradiol (2018) 28:245¿252 age/date of birth: mean age.Sex: majority gender.Event date=date of literature article publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Journal: clinical neuroradiology title: endovascular treatment for near occlusion of the internal carotid artery: 30-day outcome and long-term follow-up background: the treatment strategy and the correct incidence of near occlusion (no) of the internal carotid artery (ica) is still controversial.In routine radiological imaging no can easily be misdiagnosed as complete occlusion and there is no consensus on the standard treatment strategy.Purpose: to present our perioperative and long-term followup results of ica no patients treated with carotid artery stenting (cas).Material and methods: between 2004¿2014 a total of 182 patients with ica no were evaluated for cas.The study included 132 male (72.5 %) and 50 female (27.5 %) patients with a mean age of 70.2 years.Patients underwent a clinical neurological evaluation and radiological imaging of the carotid arteries before the cas procedure.Of the patients 80 (44 %) were asymptomatic.The median clinical and carotid doppler ultrasound (dus) follow-up period was 64 months (range 18¿124 months).A percutaneous transfemoral approach was used for cas in all cases.All lesions were pre-dilated and embolic protection was used.After pre-dilatation, intimal dissection was seen in 29 patients which was treated with stenting.Results: in 182 patients cas were performed, 4 patients (2.2 %) developed minor stroke, 2 patients (1.1 %) developed myocardial infarction but no major stroke or death occurred in the following 30-day period.One patient stopped taking dual antiplatelet medication after discharge from hospital and developed and ipsilateral major stroke 45 days after the procedure.Asymptomatic restenosis was detected in seven patients (3.8 %) in the follow-up period.These patients were treated with stents and post dilation.During the subsequent follow-up period 21 patients died ¿ 12 from vascular causes and 9 from nonvascular causes.Conclusion: with sufficient neurological evaluation during pretreatment and posttreatment periods and when the procedure is performed with technologically developed products by an experienced interventional team, cas is beneficial in patients with ica no.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7674098
• MDR Text Key: 113565499
• Report Number: 2183870-2018-00372
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 08/08/2018
• 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