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

Catalog Number	SPD2-US-070-320
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a peripheral vascular intervention using the spiderfx filter, severe calcification, and >75% stenosis of a 60mm lesion in the right distal superficial femoral artery/proximal popliteal artery, the physician experienced difficulty fully collapsing and capturing the spiderfx filter into a trailblazer catheter after lesion treatment.The device had passed through a previously deployed protege everflex.A nanocross was used for post-dilation.The trailblazer catheter became caught on the distal end of a 7fr non medtronic sheath parked in the proximal superficial femoral artery and could not be pulled through.An attempt was made to maintain vessel access with a 0.035" stiff angled glidewire and to replace the sheath, but upon removal, the spiderfx filter became caught at the left common femoral arteriotomy site and could not be retrieved.Further attempts to recapture the filter resulted in the filter snapping off the wire and remaining within the patient's soft tissues.Surgical cutdown on the left groin was required to retrieve the filter, and contralateral groin access was obtained to place a covered stent at the left common femoral arteriotomy site.Post-angiogram imaging showed no signs of extravasation.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the physician does not believe the trailblazer to be the cause of the event since the spider fx couldn't even be pulled through the 7fr sheath.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis device returned with the filter wire only.The catheter was not present kink to wire filter basket detached from distal end of wire medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SPIDER FX
• Common Device Name: 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: 23851467
• Report Number: 2183870-2025-00591
• Device Sequence Number: 9599681
• Product Code: NTE
• UDI-Device Identifier: 00821684068380
• UDI-Public: (01)00821684068380(17)270529(10)C113573
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K111010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: C113573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/27/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 76 KG