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

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

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Obstruction/Occlusion (2422)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A journal article was submitted detailing a clinical trial for government approval of a non-medtronic device in patients at either high or normal risk for carotid endarterectomy.163 patients were included in the study.Medtronic¿s spider fx embolic protection device and mo.Ma ultra cerebral protection device were used 5.7% of cases each.Multiple protection devices were used in 19.3% of procedures.Clinical event¿s of left hemiparesis in one patient which occurred immediately after stent deployment, and the responsible infarction was revealed in the right frontal and occipital lobe, and one patient presented with left hemiparesis 1day after cas where carotid ultrasonography revealed plaque protrusion within the stent, requiring additional stenting with percutaneous transluminal angioplasty the same day.There were no reports of death or mi within 30 days, and no ipsilateral stroke within 1year after the procedure.The tlr rate was 2.4%, and additional treatments were performed 180¿365 days after stent placement in two cases and 1 day after in one case.Cerebrovascular events occurred in 7.2% of cases including ischemic stroke and tia in 2 and 8 cases respectively.Severe stroke resulting in neurological symptoms lasting >7 days and deterioration of the national institutes of health stroke scale (nihss) score occurred on the day of the procedure in one case.Minor stroke, which resolved within 7 days or presented with a deterioration in nihss score was encountered within 1¿30 days in one case.No instances of ipsilateral stroke were recorded between 30 days and 1year.Tias occurred at any time, with 2, 3, and 3 tias occurring on the day of cas, within 1¿30 days, and between 30 days and 1year, respectively.One patient had cranial nerve palsy, but this was a bilateral facial palsy unrelated to the stenting.

• Brand Name: SPIDER FX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC 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 ; EI ; 091708734
• MDR Report Key: 12041556
• MDR Text Key: 257481307
• Report Number: 2183870-2021-00228
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2021

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: 06/15/2021
• Initial Date FDA Received: 06/22/2021
• 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: 74 YR