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

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

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 vascular surgeon practising in italy who within the last 12 months used a spiderfx embolic protection device for distal embolization protection during peripheral interventions (52 procedures), coronary interventions (14 procedures), and carotid interventions (57 procedures).During use of the spiderfx embolic protection device during peripheral interventions the following adverse events/complications are reported: adverse reaction to contrast media, device thrombosis (acute and subacute), gastrointestinal bleeding due to anticoagulation, infection, puncture site infection, repeat intervention to treatment site, thrombosis (acute and subacute).During use of the spiderfx embolic protection device during coronary interventions the following adverse events/complications are reported: gastrointestinal bleeding due to anticoagulation, infection,puncture site infection, significant cardiac arrhythmia requiring treatment medications and/or transvenous pacing, transient ischemic attack (tia) or stroke.During use of the spiderfx embolic protection device during carotid interventions the following adverse events/complications are reported: adverse reaction to antiplatelet/anticoagulation agents, amaurosis fugax, infection, puncture site infection, transient ischemic attack (tia) or stroke, vessel dissection, perforation, rupture, intimal flap.During use of the spider embolic protection device for peripheral, coronary and carotid interventions, there were: three adverse reactions to antiplatelet/anticoagulation agents, one adverse reaction to contrast media, one event of amaurosis fugax, one event of device thrombosis (acute and subacute) reported as arterial thrombosis, five reports of gastrointestinal bleeding due to anticoagulation, six infection events reported as a soft tissue infection in a diabetic patient, five puncture site infection events described as a surgical site infection, two repeat intervention to treatment sites required due to technical failure where reintervention was required, one significant cardiac arrhythmia requiring treatment medications and/or transvenous pacing, two thrombosis (acute and subacute) events, two transient ischemic attack (tia) or stroke events, and one vessel dissection, perforation, rupture, intimal flap event.The following events were reported to be not at all concerning: adverse reaction to antiplatelet/anticoagulation agents, adverse reaction to contrast media, amaurosis fugax, device thrombosis (acute and subacute), gastrointestinal bleeding due to anticoagulation, infection, puncture site infection, repeat intervention to treatment site, thrombosis (acute and subacute), transient ischemic attack (tia) or stroke, and vessel dissection, perforation, rupture, intimal flap.Of these events all were deemed to be not device related with the exception of one case of device thrombosis (acute and subacute), one case of infection, all cases of puncture site infection, one of the repeat interventions to treatment site.

• 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: 9127691
• MDR Text Key: 166373465
• Report Number: 2183870-2019-00467
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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