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 Stenosis (2263); Vascular Dissection (3160)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

Event date (date of published article) title: endovascular treatment of patients with isolated mesenteric artery dissection aneurysm: bare stents alone versus stent assisted coiling eur j vasc endovasc surg (2019) 57, 400e406.Https://doi.Org/10.1016/j.Ejvs.2018.08.057.If information is provided in the future, a supplemental report will be issued.

Event Description

A (b)(6) year old man presented with acute abdominal pain that had lasted for three days.Superior mesenteric arteriography demonstrated dissection aneurysm at the curve of the sma, and the true lumen was compressed.Superior mesenteric arteriography demonstrated complete resolution of the dissection aneurysm immediately after placement of two bare stents.Contrast enhanced computed tomography (ct) demonstrated that the dissection aneurysm was completely thrombosed with good stent patency one month after treatment.A new dissection aneurysm was observed on the repeat contrast enhanced ct scan performed six months later.Superior mesenteric arteriography demonstrated the dissection aneurysm, and complete resolution of the dissection aneurysm was achieved after coiling via the stent mesh using a microcatheter.Complete resolution of the dissection aneurysm with good stent patency was observed one year after treatment.Severe stenosis of a branch of the sma was also observed on superior mesenteric arteriography.

• 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 ; 091708734
• MDR Report Key: 8554584
• MDR Text Key: 143245028
• Report Number: 2183870-2019-00191
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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: 04/12/2019
• 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: 50 YR