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

Catalog Number SEPX-8-6-40-135

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use the spider fx embolic protection device along with protege rx carotid stent during procedure to treat severely calcified lesion in the proximal right common carotid artery.The vessel exhibited 90% stenosis.The vessel was pre-dilated.Ifu was followed.Angiography was performed.There was an issue identified of preparing the spider and stent of appropriate specifications.It was reported that the spider was hung on the stent when it was being taken out of the body and could not be taken out.The stent did pass through a previously deployed stent.No resistance was encountered advancing device.The procedure was completed by taking out the spider and stent by carotid artery peeling.The devices were surgically removed from the patient.No vessel damage noted.No patient injury.

Manufacturer Narrative

Product analysis: the spider fx device was returned to medtronic investigation lab for evaluation.The deployed stent was returned along with a basket from a spider fx device inside a small ziplock bag in a biohazard bag in its shelf carton.The deployed protégé rx stent was received along with a basket from a spider fx device.The stent was confirmed as 40mm.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.

• 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: 12984462
• MDR Text Key: 286766220
• Report Number: 2183870-2021-00454
• 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,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B262575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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: 71 YR
• Patient Sex: Female