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

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

Patient Problem Restenosis (4576)

Event Date 01/19/2020

Event Type  Injury  

Manufacturer Narrative

Journal article title: safety and efficacy of conservative, endovascular bare stent and endovascular coil assisting bare stent treatments for patients diagnosed with spontaneous isolated superior mesenteric artery dissection interventional radiology/vascular surgery videosurgery and other miniinvasive techniques 4, december/2020 videosurgery miniinv 2020; 15 (4): 608¿619 doi: https://doi.Org/10.5114/wiitm.2020.92403.Date of publication online.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to evaluate the safety and efficacy of conservative, endovascular bare stent and endovascular coil assisting bare stent treatments for patients diagnosed with spontaneous isolated superior mesenteric artery dissection (sismad).62 patients were included in the study.Medtronic bare self-expanding stents were implanted.Within the stenting group (39 patients) and the stenting and coiling group (9 patients) technical success is reported in 97.4% and 100% of cases respectively.1 failure is reported in the stenting group where a secondary treatment was required.In the case with the reported failure, the patient underwent fasting and was discharged from the hospital after 5 days.Eleven days after discharge, the patient was readmitted with recurrence of symptoms, cta was performed, and restenosis was revealed.The patient was kept under observation for 2 days in which symptoms persisted then secondary treatment was performed whereby a 7 mm by 21 mm stent was deployed successful.

• 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: 11326861
• MDR Text Key: 234905188
• Report Number: 2183870-2021-00067
• 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: 02/15/2021

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: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• 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: 53 YR