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

Catalog Number PRB35-06-080-120

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/19/2024

Event Type  Injury  

Event Description

During the index procedure three protege everflex stents were used to treat the right common iliac, external iliac.1 day post procedure patient suffered severe left lower extremity critical limb threatening ischemia with tissue loss. bilateral lower extremity severe peripheral arterial disease with tissue loss of the left lower extremity.Severe left lower extremity critical limb-threatening ischemia with tissue loss.The patient underwent bilateral iliac artery stenting to facilitate above the knee amputation.Both common iliac arteries were occluded, and the patient had an occluded sfa on the left side.The foot was beyond salvage, and in addition, infected with leukocytosis.The left lower extremity digit 1 gangrene and digit 2 impending ischemia and an abi of.3 upon arrival to the hospital. patient recovered.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM 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: 19163738
• MDR Text Key: 340825977
• Report Number: 2183870-2024-00136
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRB35-06-080-120
• Device Lot Number: B345716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White