MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

Device Problems Fracture (1260); Positioning Problem (3009); Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: bare stents for iliac chronic total occlusions (¿¿telis¿¿): a prospective cohort study with a midterm follow-up doi: 10.1016/j.Avsg.2020.05.046.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to assess primary bare stenting for iliac chronic total occlusions (ctos) with midterm follow-up.46 patients with 49 iliac ctos treated were included in the study.Medtronic¿s assurant cobalt and everflex stents were implanted.The technical success rate was 98%.One technical failure occurred because of impossible cia occlusion¿s crossing both by crossover and brachial access.No surgical conversion was observed.Four extended dissections of downward segment to the lesion were observed (2 eia and 2 cia) and successfully treated by adjunctive stenting.Two closure devices (non-medtronic) failures and 3 minor hematomas were observed.One complication not related to the procedure occurred (hyperkalemia with arrhythmia).6 non-procedural related deaths were reported in the population at 2 years.Other outcomes at 2 years include three major cardiovascular events were reported, 2 strokes and 1 myocardial ischemia.No major amputation was noted.Three thrombosis were observed (1 at 1 month and 2 at 2 years).Tlr was performed by open surgery with iliofemoral thrombectomy and cross-femoral bypass for 2 patients.One patient had a redo surgery for stent migration which was treated endovascularly by cia kissing-stent procedure.Three stent fractures were noted, one type 1 located at the cia level and two type 2 at the eia level.None of those fractures led to symptoms, restenosis, thrombosis, or reintervention.There is no established or suspected causal relationship between the device(s) and the death events.

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per d00916038.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: ASSURANT COBALT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 11796431
• MDR Text Key: 249671274
• Report Number: 9612164-2021-01827
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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: 59 YR
• Patient Sex: Male