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

Model Number SPD2-US-070-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Patient Problem/Medical Problem (2688); Unspecified Tissue Injury (4559)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was using a hawkone m to treat a severely calcified 120mm cto in the proximal common iliac artery, superficial femoral artery and popliteal artery.Little tortuosity was reported in the 6mm diameter vessel.A 7mm 0.14 spiderfx embolic protection, trailblazer and a 6fr cook sheath were also used in the procedure.The ifu was followed and the vessel was predilated.It was reported that after completing the atherectomy with the hawkone, the spiderfx could not be retrieved into the recovery catheter.It could not be retrieved into the trailblazer 6fr guide catheter or the sheath.When attempting to exchange the sheath to a 7r the basket on the spiderfx snapped off and the patient was taken to surgery for a cutdown to remove the detached wire.

Manufacturer Narrative

Additional information: a large amount of calcium was present in the access site.There was no resistance encountered when advancing the device.No allegation reported against the sheath or trailblazer support catheter used.Difficulty was experienced due to the size of the spider filter when full and attempted to be removed.The 6fr sheath used was unable to accommodate the full spider fx filter basket as it was bigger than the internal diameter of the 6fr sheath used.As well as during attempts to change to a 7fr sheath, the spider fx filter was also caught on the calcium at the access site which contributed to the detachment of the basket.The basket was removed from the patient intact and all particulate remained in the basket.Endarterectomy was also performed.Patient has had no issues post surgery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the spider fx embolic protection device was used to treat the right leg.This resulted in a tearing of the femoral artery requiring emergency surgery to repair the artery and remove the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8451212
• MDR Text Key: 139810494
• Report Number: 2183870-2019-00147
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068380
• UDI-Public: 00821684068380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: SPD2-US-070-320
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: A564394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 04/22/2022
• Supplement Dates FDA Received: 04/11/2019; 05/17/2022
• Date Device Manufactured: 12/04/2017
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 132 KG