MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING BILIARY STENT SYSTEM 018; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Rupture (2208); Embolism/Embolus (4438)

Event Date 08/18/2023

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'endovascular thrombectomy for acute iliofemoral deep venous thrombosis through a ju gular approach with a rotational device'.The study aimed to report the effectiveness of pharmacomechanical catheter-directed thrombolysis (pcdt) in the management of acute i liofemoral deep venous thrombosis (dvt) via the jugular vein using a slow rotation and largetip device (srd) in a large cohort of patients.From 2011 to 2021, 277 patients(mean age 45 years, 59.2% women) were treated in 6 centres with pcdt for ilio-fe´moral dvt.Pcdt was performed via the jugular vein and consisted of one session of fragmentation¿fibrinolysis, aspiration and, if needed, angioplasty with stenting.When there was an obstacle to venous return (i.E.Venous stenosis or stagnation of contrast media) at the end of the procedure, angioplasty with stenting was performed.Stents used were self-expanding nitinol stents, 12¿14 mm in diameter, of the following makes and models: optimed sinus xl flex, cook zilver and ev3 protege gps (10%).Immediate outcome and complications included: death (pulmonary embolism) 1 major complications 5 pulmonary embolism 2 haemoptysis 1 device trapping in a stent 1 minor complications 11 venous access haemorrhage or haematoma 6 pulmonary embolism 3 severe complications were observed in 5 patients (1.8%), 2 due to severe pe requiring systemic fibrinolysis in both cases and ecmo in one; the latter patient died.The severe haemoptysis was due to an associated false pulmonary artery aneurysm on an aspergilloma that was successfully treated by embolization.There was entrapment of the ptd system in the stent in one patient due to the mesh of the stent wrapping around the basket; it required forceful removal of the stent and device, involving a contralateral femoral surgical approach to extract the stent and resulting in contralateral iliofemoral-dvt.The treated vein remained patent.The minor complication rate was 4%, attributed to bleeding and embolic problems.The only death that occurred was in a case with a severe clinical presentation at the time of management that involved a very high t hrombotic load.Death occurred after treatment of extensive let 3¿4 dvt with a high thrombotic load.Despite balloon occlusion of the ivc during pcdt, the occlusion was not complete, and blood clots migrated along the balloon and resulted in massive pe treated with extracorporeal membrane oxygenation (ecmo).The patient died on day 5 of multivisceral failure.This patient did not have an ivc filter.

Manufacturer Narrative

Endovascular thrombectomy for acute iliofemoral deep venous thrombosis through a jugular approach with a rotational device cardiovasc intervent radiol (2023) 46:1684¿1693 https://doi.Org/10.1007/s00270-023-03529-4 a2 average age a3 majority gender b3 date of publication.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 GPS SELF-EXPANDING BILIARY STENT SYSTEM 018
• 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: 18657482
• MDR Text Key: 334724737
• Report Number: 2183870-2024-00034
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/07/2024
• 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: 45 YR
• Patient Sex: Female