MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problems Aneurysm (1708); Pain (1994); Obstruction/Occlusion (2422); Vascular Dissection (3160); Restenosis (4576)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

The impact of endovascular treatment on clinical outcomes of stable symptomatic patients with spontaneous superior mesenteric artery dissection journal of vascular surgery (2020) 73(4);1269-1276 doi: 10.1016/j.Jvs.2020.08.117 age: average age.Sex: majority gender.Event date: date of article publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Journal article presented the endovascular stenting for the treatment of superior mesenteric artery disease (smad) in the prevention of artery rupture or aneurysm.The article retrospectively reviewed all patients diagnosed with smad.The study was divided into 2 groups endovascular group and medical management group.The total number of patients in the endovascular group is 37 patients, with 34 patients successfully treated with stenting and stenting failed in 5 patients.Stenting was abandoned in five patients because the guidewire could not be navigated into the distal true lumen in three patients and because the angiography showed unsatisfactory distal outflow from the artery in the other two patients.Four medtronic stents were used in the endovascular group; everflex, protege rx, protege gps and complete se.Overall, there were no smad-related deaths or mesenteric artery ruptures.Nine patients had a recurrence of abdominal pain, four of those are in the endovascular group.There were six reintervention cases for smad, one for stent related dissection in the ostium of the mesenteric artery 8 months after the first endovascular treatment, three for aneurysm formation in the endovascular group.No significant difference was detected between the groups.There were more cases of complete or partial remodeling in the endovascular group and more unchanged dissections shown in radiological results.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12189152
• MDR Text Key: 262285325
• Report Number: 2183870-2021-00246
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• 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: 07/06/2021
• 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: 51 YR