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

Model Number	PRB35-06-040-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
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
Physician was attempting to use protégé everflex self-expanding stent during procedure to treat a calcified lesion in the patients proximal superficial femoral artery (sfa).No vessel tortuosity and moderate vessel calcification are reported.Embolic protection was not used.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified the device did not pass through a previously-deployed stent.The lesion was pre-dilated.No resistance was encountered when advancing the device and no excessive force used.It is reported the sheath broke into several parts after deployment.The procedure was completed using other devices to retrieve the pieces that had broken off the sheath.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the device was returned with the manifold safety locking pin loose.The device was returned in a deployed state with the grips pushed together the device was returned with the distal end of the outer sheath detached from the device, the nylon inner shaft was broken and the inner detached approximately 5mm proximal to retainer, there was several kinks / bends on the detached piece of outer sheath the device returned with a kink on the blue outer sheath, approx.16.2 cm distally from the strain relief no functional testing could be carried out due to the condition of the returned device.The distal inner assembly was cut just proximal to the stent retainer to allow further testing.A set of witness marks were noted on the stainless steel hypotube approximately 27mm and 29mm from the distal end of the stainless steel hypotube; indicating that the safety locking pin was properly tightened during manufacturing.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 STANDARD
• 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: 15867181
• Report Number: 2183870-2022-00404
• Device Sequence Number: 5487275
• Product Code: FGE
• UDI-Device Identifier: 00821684059883
• UDI-Public: 00821684059883
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: PRB35-06-040-120
• Device Catalogue Number: PRB35-06-040-120
• Device Lot Number: B389131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 11/27/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG