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 Unspecified Infection (1930); Occlusion (1984); Reocclusion (1985)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Average age.Majority gender.Date of event: date of publication journal article title: outcomes of chimney technique for aortic arch diseases: a single-center experiencewith226cases clinical interventions in aging 2019:14 1829¿1840 http://doi.Org/10.2147/cia.S222948.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to document a single-center experience with chimney technique for aortic arch diseases.Patient¿s with aortic arch diseases underwent thoracic endovascular aortic repair combined with chimney stents.During the treatment medtronic¿s complete se, maris, and protégé rx devices were among those used.Tevar was done in emergent situations in 4 patients with aortic rupture and in6 acute tbad patients with intestinal ischemia or lower extremity ischemia.The aortic stentgrafts were positioned proximally in zone 0 (10%), zone 1 (6%), or zone 2 (84%) according to the ishimaru classification.Seventeen patients received two aortic stent-grafts and one patient received three aortic stent-grafts.230 chimney stents were installed in 226 patients, where double chimney technique (lcca + lsa) was done in four cases.The majority (84%) chimney stents were bare stents, and (77%) were self-expandable stents.The chimney graft was installed as a bailout to restructure the lcca in 6 patients with partial unintended coverage of the lcca during tevar.For zone 1 patients who received a single lcca chimney stent, occluded lsa was not a routine procedure.The average duration of postoperative hospital stay was 8 ± 5 days.The technical success rate was 84%.In the present study, immediate type ia endoleak (elia) occurred in 16% of patients.Given that the elia had low flow and most of the immediate elia would diminish or disappear during the follow-up, these immediate elia were treated conservatively with close surveillance.No complications due to anaesthesiaor supra-aorta bypass occurred in zone 0 patients.Other complications noted include, puncture site complications, femoral artery stenosis or occlusion, brachial artery pseudoaneurysm, brachial artery local infection.The 30-day mortality rate was 2%.The causes for deaths were ventricular fibrillation in one case, aortic rupture in one case, and major stroke in two cases.A total of four major strokes were documented, including the two that ultimately led to deaths in hospital.The other two patients gradually recovered at discharge.Spinal cord ischemia happened in three cases, out of which one was temporary (grade 2) and the other two were everlasting (grade 3a).Reintervention was not documented.Hence, the main aes rate was 4% during the early term.98% patients were effectively followed up by hospital visits or telephonic interviews to evaluate survival.The average period of medical follow-up was 22 ± 16 months.In the course of the follow-up, deaths were reported in five patients.Three of them were due to aortic rupture, one was due to cerebral haemorrhage and the last one was due to rectal cancer.Besides, two patients suffered from stroke.One patient received reintervention due to the distal expansion.Follow-up imaging results for only 78% patients included to assess aorta morphology as well as the patency of chimney stents or bypasses.The average period of imaging follow-up was 20 ± 15 months.Among these 173 patients, 139 were tbad, 20 were aneurysms and 14 were other pathologies (penetrating aortic ulcer, intramural hematoma or aortic rupture).There was no substantial change in the maximum aortic diameters among those with and without elia.For patients with aneurysms, there were five patients with sac regression, and the maximum diameters of aneurysm decreased from 60.5 ± 5.3 mm to 57.2 ± 4.9 mm, 91% patients with tbad had completed false lumen occlusion during follow-up.Amongst 37 cases with immediate elia, nine patients became inaccessible.Among the remaining 28, four original elia continued; late elia were detected in two patients with tbad, and the false lumens were partially thrombosed in these two cases.The occlusions of chimney stent in lsa were recorded in 3% patients.And all the aortic arch bypasses were patency.

• 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 ; IE ; 091708734
• MDR Report Key: 9799952
• MDR Text Key: 196391681
• Report Number: 2183870-2020-00071
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• 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 Age: 54 YR