MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	PRB35-06-200-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by patient representative that a patient has had a rash ever since having 2 visi-pro balloon expandable stents and 2 protégé everflex stents implanted to treat the left iliac and left sfa and popiteal vessels.Symptoms started 1 day post procedure.The physician doesn¿t think there was any issues during stent implantation.Physician did not determine the stents led to patient symptoms.Patient currently being treated with cream provided by dermatologist.No further patient injury reported.
Additional 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.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 14208995
• Report Number: 2183870-2022-00149
• Device Sequence Number: 17191784
• Product Code: FGE
• UDI-Device Identifier: 00821684059999
• UDI-Public: 00821684059999
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: PRB35-06-200-120
• Device Catalogue Number: PRB35-06-200-120
• Device Lot Number: B205563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 08/10/2022
• Date Device Manufactured: 05/13/2021
• 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: Other
• Patient Sex: Male