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

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Restenosis (4576)

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 w ere 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.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11796425
• MDR Text Key: 249664662
• Report Number: 9612164-2021-01826
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• 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
• Patient Age: 59 YR