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 Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Occlusion (1984); Transient Ischemic Attack (2109)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Patient age: average age.Sex: majority gender.Event date: date of article publication 1-month results from a prospective experience on cas using cguard stent system jacc: cardiovascular interventions (2020) 13(18); 2170-2177 10.1016/j.Jcin.2020.05.026.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (cas) in the clinical practice.733 patients were included in the study.Medtronic¿s distal filter device, spider fx and proximal occlusion mo.Ma protection device¿s were used in 80.90% and 18.82% of procedures respectively.In 2 patients, no epd was used because the operators considered the use of any epd to be unsafe.Clinical events of access site vascular complications were detected in 4 cases, consisting in all cases of an access site hematoma were reported.3 strokes, 1 fatal and 2 minor are reported in the first 24 post-operative hours.6 transient ischemic attacks (tias) were noted, and 1 patient experienced an acute myocardial infarction (ami).Fatal stroke was due to a hemorrhagic conversion as a consequence of a cerebral reperfusion syndrome following an emergent cas procedure performed for unstable evolving symptoms.At pre-discharge, external carotid artery (eca) occlusion was evident in 8 patients in absence of any neurological consequence.30 day follow-up results indicated 1 minor stroke, 2 patients experienced tia, 3 patients experienced nonfatal ami.At dus examination, neither treated ica restenosis nor new eca occlusion was detected.30-day cumulative outcomes reported as stroke (4), death (1), stroke and death (5), and ami (4).

• 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 ; IE ; 091708734
• MDR Report Key: 10695492
• MDR Text Key: 212263358
• Report Number: 2183870-2020-00337
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063204
• 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
• Report Date: 10/19/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/19/2020
• 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 Age: 73 YR