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

Model Number	PRB35-06-080-120
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	11/06/2020
Type of Reportable Event	Malfunction
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 protege everflext during procedure to treat a moderately calcified lesion in the mid superficial femoral artery (sfa) with 80% stenosis.The vessel was moderately tortuous.There was no damage noted to packaging.There was no issues noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that while deploying the stent, the proximal "pull" segment detached from the catheter.The break/fracture occurred at the handle.Nothing detached in the body.The lesion was not pre dilated.The device did not pass through a previously-deployed stent.No resistance encountered when advancing the device.The physician was able to deploy the stent using a firm grip on the outer sheath that constrains the stent.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the stent was properly deployed and place where the physician wanted.There was no issues with the stent itself.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.
Additional Manufacturer Narrative
Device evaluation the device was returned with the distal grip beside the proximal grip and the distal grip detached from the outer shaft.There is a bend approximately 110cm from the tip.There is a kink on the inner shaft adjacent to the tip.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
• MDR Report Key: 10859587
• Report Number: 2183870-2020-00391
• Device Sequence Number: 11380136
• Product Code: FGE
• UDI-Device Identifier: 00821684059920
• UDI-Public: 00821684059920
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: PRB35-06-080-120
• Device Catalogue Number: PRB35-06-080-120
• Device Lot Number: B062922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 05/21/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/15/2020; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 87