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 Arrhythmia (1721); Hematoma (1884); Hemorrhage/Bleeding (1888); Occlusion (1984); Thrombosis (2100); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the spiderfx embolic protection device.Survey results received from a cardiothoracic surgeon practising in italy who within the last 12 months used a spiderfx embolic protection device for distal embolization protection during peripheral interventions (20 procedures), coronary interventions (16 procedures), and carotid interventions (15 procedures).During use of the spiderfx embolic protection device during peripheral interventions the following adverse events/complications are reported: hematoma, hemorrhage, pseudoaneurysm, thrombosis (acute and subacute), and vasospasm.During use of the spiderfx embolic protection device during coronary interventions the following adverse events/complications are reported: arrhythmia, hematoma, hemorrhage, thrombosis (acute and subacute), and vasospasm.During use of the spiderfx embolic protection device during carotid interventions the following adverse events/complications are reported: amaurosis fugax, hematoma, hemorrhage, thrombosis (acute and subacute), and vasospasm during use of the spider embolic protection device for peripheral, coronary and carotid interventions, there was: one amaurosis fugax event, two arrhythmia events, three hematoma events, three hemorrhage events, two pseudoaneurysm events , two thrombosis (acute and subacute) events and two vasospasm events reported.The amaurosis fugax event and hematoma events were reported to be not at all concerning and the arrhythmia, hem orrhage, pseudoaneurysm, thrombosis (acute and subacute), and vasospasm events were reported to be somewhat concerning.The arrhythmia event which was reported to be transient and not dangerous, two of the hematoma events which were small and spontaneously absorbed, two of the hemorrhage events for which the patient was receiving dual antiplatelet therapy, one of the pseudoaneurysm events which were very rare and not complicated, one of the thrombosis (acute and subacute) events which resolved after a few days, and one of the vasospasm events which was unclear and of dubious origin were reported to be device related.The amaurosis fugax event was reported to not be device related.

• 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 ; 091708734
• MDR Report Key: 9010101
• MDR Text Key: 162292762
• Report Number: 2183870-2019-00448
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• 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