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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Article title: factors associated with hemodynamic instability following carotid artery stenting clinical neurology and neurosurgery 203 (2021) 106589 https://doi.Org/10.1016/j.Clineuro.2021.106589.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to identify the risk factors of hemodynamic instability associated with carotid artery stenting (cas).128 patients who underwent cas were included in the study.Medtronic¿s spider fx distal embolic protection device was used for intra-procedural neuroprotection, and protégé stent was selected in all cases.18 of the study subjects were administered intravenous atropine for bradycardia during the procedure and 15 received vasopressor infusion due to persistent hypotension post-cas.The author concludes if a carotid stenotic lesion involves the carotid bulb, the risk of hemodynamic instability, including periprocedural bradycardia and postprocedural persistent hypotension, associated with cas may also increase.There is no device malfunction reported.

• 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: 12279159
• MDR Text Key: 265126210
• Report Number: 2183870-2021-00278
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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: 07/08/2021
• 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: 72 YR