MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 07/11/2022

Event Type  Injury  

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.

Event Description

Physician was attempting to use a spider fx during procedure to treat a lesion in the common carotid artery (cca). it was reported that during initial advancement, resistance was felt and kink occurred. the delivery guide wire was kinked. the patient was a stent implanted patient on 7.11 and suffered from acute cerebral infarction.After the non-medtronic guidewire and microcatheter passed through the lesion to reach the internal carotid ophthalmic artery, the distal development was found to be normal on hand push angiography, and it was judged that the protege in-stent and internal carotid artery thrombosis was formed, accompanied by in-stent restenosis.They wanted to use the embolic protector for distal protection, the in-stent balloon was dilated.After the spider was opened, the surgeon repeatedly rinsed the spider, penetrated it into the saline to discharge the air, and fully hydrated.After the spider wa s taken out from the annular dispenser, the delivery guide wire was slowly advanced, the spider was slowly deployed from the spider sheath, and then the delivery guidewire was slowly retracted, the spider could enter the spider sheath smoothly, and then the spider was slowly raised along the non-medtronic guidewire.In the beginning, the spider could be raised slowly and smoothly.The surgeon gently pushed the delivery guidewire, and suddenly found resistance, then stopped the operation and retracted the spider.Later, it was found that the spider delivery guidewire was kinked and damaged.The surgeon repeated the previous operation again and raised the spider, but the delivery guidewire could not be raised smoothly in the y valve, and the resistance was very large.After several attempts, the problem still could not be solved.After careful consideration, the patient was diagnosed with acute cerebral infarction.In order to ensure that the patient's blood vessels could be quickly recanalized and reduce the death of brain cells, it was replaced with a new product and the above operations were repeated.No abnormality was found, the operation was performed smoothly, and the blood vessels were recanalized smoothly.The thrombus and cerebral infarction was not a result of the spider device kink.The thrombus and cerebral infarction were not a result of prolonged procedure time.The protégé stent was implanted before this current procedure.The in-stent restenosis was noted immediately following implant during angiography.No further patient injury reported.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• 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: 15202364
• MDR Text Key: 297686004
• Report Number: 2183870-2022-00251
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• 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
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• 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