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

Catalog Number PRP35DR-06-200-120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/25/2021

Event Type  Injury  

Event Description

A patient was admitted to hospital with a complaint of intermittent pain in both lower limbs for more than two months.After being admitted to the hospital, the preoperative examination was completed and after the surgical contraindications were excluded percutaneous balloon dilatation of the right lower extremity and implantation of arterial stent were performed.The operation went well and a protégé everflex 6mm*200mm stent and non-medtronic stent were implanted successively in the lesion in the distal region of the superficial femoral artery.One 6mm*150mm bracket each.The artery was mildly tortuous.The device was prepped as per the ifu with no issues identified.The lesion was pre-dilated with a 3.5mm,4mm,5mm device.The surgery was completed successfully.The patient recovered well postoperatively.It was reported post operatively, the first infection and fever started.Approx 2 months post index the patient underwent percutaneous balloon dilatation of the left lower extremity and intraarterial stent implantation.The patient experienced fever, redness and swelling of the right lower extremity, etc., consider stent infection and sepsis.Infection treatment was provided before amputation.Explanting of the stent was required.Approx 3 months post index the right thigh amputation was performed.During the operation, two pseudoaneurysms were found at the bridge of the stent.Aneurysm formation, the infection of the patient's right lower extremity was identified.It is reported the infection of the patient's right lower extremity was probably the result of mars stent colonization.In this case, there was medical negligence and there was a causal relationship with the amputation of the patient's right lower limb.The infection may be related to various aspects such as the stent, surgical operation, and environment, so a definite conclusion cannot be obtained.

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.

Manufacturer Narrative

Image analysis the customer returned two images for evaluation it appears two images are pasted into same attachment.It is inconclusive what the top picture is depicting, unable to view the vessels.Description above image is not in english.It is also unclear from event description which sfa the stent was placed in, and it is inconclusive where the stent is in the second image.The second image shows an explanted artery with a likely pseudoaneurysm.Unable to assess what artery this is.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.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• 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: 17072250
• MDR Text Key: 316670986
• Report Number: 2183870-2023-00205
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110023
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Catalogue Number: PRP35DR-06-200-120
• Device Lot Number: B164573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Date Device Manufactured: 02/21/2021
• 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