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 Problem Stroke/CVA (1770)

Event Date 10/07/2021

Event Type  Injury  

Event Description

A journal article was submitted which evaluated the safety and feasibility of total cerebral protection methods using embolic protection devices (epds) for carotid artery stenting.Case 5 presents a patient who had a potentially high risk of cerebrovascular events during the procedure.The patient was treated wi th 2 spider fx devices.Due to patient condition an anterograde approach was to the right carotid artery was planned through the same guiding catheter used to protect the left carotid artery, via the left femoral access route.The right vertebral artery was protected via the right brachial artery.The 6-mm spider fx was deployed in the right internal carotid artery, and a 5-mm spider fx was deployed in the left vertebral artery.Mri on the day after the procedure showed new ischemic lesions asymptomatic acute cerebral infarction was detected.No device malfunction reported.

Manufacturer Narrative

Title: "tailor-made" total cerebral protection during transcatheter aortic valve implantation author: keita suzuki, masaomi koyanagi, shinichi shirai journal: neurologia medico-chirurgica year: 2021 vol/issue: 61(12) ref: 10.2176/nmc.Oa.2021-0005 date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13665933
• MDR Text Key: 286563145
• Report Number: 2183870-2022-00075
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: 03/02/2022
• 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): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male