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

Catalog Number SPD2-060-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  Injury  

Event Description

Physician attempted to use a spider fx embolic protection device/guidewire during treatment of a fibrous lesion the patient¿s proximal common carotid artery.Severe vessel tortuosity and little vessel calcification were reported.Lesion exhibited 90% stenosis.There were no abnormalities reported in relation to anatomy.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.The lesion was post dilated.Tip detachment was reported as the surgery was about to end.After the spider was finally retracted, it was discovered that the guidewire tail of the spider was separated from the spider filter.The spider body was retracted, but the guidewire tail remained in the blood vessel.The surgeon was worried that the guidewire tail would be rushed into the skull by the blood flow.Therefore, the surgeon first selected a non-medtronic stent, attached it to the broken guidewire, and used the stent to press the separated guidewire tail against the blood vessel wall.No patient injury reported.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient was not harmed.The doctor believed that the tip of the spider's tip was damaged because the tip was separated from the spider and remained in the blood vessel.Normally, the tip of the spider came out together with the spider body, but this time the tip was separated from the spider body, so the doctor thought that the tip of the spider tip was damaged.There was no difficulties in placing the spider at the beginning of the procedure and there was no difficulty removing the spider.A total of two stents were placed during the surgery, one to treat the lesion and the other to fix the distal tip.There was no carotid dissection and the reason for surgery was carotid stenosis.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
• 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: 18904656
• MDR Text Key: 337672297
• Report Number: 2183870-2024-00085
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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 Catalogue Number: SPD2-060-320
• Device Lot Number: B563873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/11/2024
• Date Device Manufactured: 05/14/2023
• 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: 69 YR
• Patient Sex: Female