MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number SERB65-10-40-120

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

A protégé gps was intended to be implanted for the treatment of an unknown lesion in the mid left region of the common iliac artery.A 7fr sheath and non mdt guidewire were used.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 9mm x 30 pre-dilation devices.The thumbscrew/lock-pin was checked for securement.The lock pin was not removed just loosened prior to deployment.The device had not passed through a previously deployed stent and no excessive force was used.It was reported that the stent partially deployed and then froze on the wire.Stent deployed on wire prior to insert in patient.The whole system partially deployed, and the wire was removed from the patient through the sheath and the case was finished with a balloon angioplasty.No vessel damage reported, and no patient injury reported for this event.

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.

Manufacturer Narrative

Image analysis: the customer returned one image for evaluation this image appears to show a section of a patients vasculature system with what appears to be a device in the patients vasculature system.The image returned is not of high quality and appears very grainy.Product analysis the device was returned with the manifold safety locking pin tight.The device was returned with a guidewire stuck inside the device, the distal tip partially pushed into the outer sheath and the guidewire was confirmed to be 0.035¿ the grip distance, deployment paddles approximately 58mm the proximal deployment paddle was pinned, and the distal deployment paddle was pulled, the stent deployed the stent was confirmed as 40mm, with no abnormalities or biologics noted on the stent, (photo 10).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 GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
• Type of Device: 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: 16271335
• MDR Text Key: 308831579
• Report Number: 2183870-2023-00041
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00643169729049
• UDI-Public: 00643169729049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

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
• Device Operator: Health Professional
• Device Model Number: SERB65-10-40-120
• Device Catalogue Number: SERB65-10-40-120
• Device Lot Number: B288920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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