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 Bradycardia (1751); Embolism (1829); Headache (1880); Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Low Blood Pressure/ Hypotension (1914); Pain (1994); Transient Ischemic Attack (2109); Convulsion, Clonic (2222); Stenosis (2263); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

The safety of carotid artery stenting for patients in the acute poststroke phase journal of stroke and cerebrovascular diseases volume 27, issue 1, january 2018, pages 83-91 https://doi.Org/10.1016/j.Jstrokecerebrovasdis.2017.08.008.Event date is literature article published date.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Background the efficacy of carotid artery stenting (cas) for patients in the acute poststroke phase has not been established.We investigated the outcome of cas for patients with symptomatic internal carotid artery (ica) stenosis in the acute poststroke phase.Methods we performed a retrospective analysis of all patients who underwent cas for symptomatic ica stenosis in our institution.Patients in whom the time interval between neurological deterioration and the cas procedure was less than 3 days were included in the early group, and the other patients were included in the delayed group.Perioperative complications including major adverse events (maes) were compared between the early and the delayed groups.Results one hundredfive patients were included in the study.Forty patients were assigned to the early group and 65 patients were assigned to the delayed group.The overall mae rate was 4.8%.There was no significant increase in the perioperative mae in the early group compared with the delayed group (early group 2.5% versus delayed group 6.5%, p¿=¿.65).In the early group, 25 of 40 patients (62.5%) were functionally independent (modified rankin scale [mrs] score of 0-2) at discharge.Significant differences between the independent patients and the disabled patients (mrs score of 3-6) included age (independent 72 versus disabled 79, p¿ <¿.01) and prevalence of transient ischemic attack (36.0% versus.0%, p¿=¿.02).Conclusions cas performed within 3 days from the last ischemic event did not increase the risk of perioperative complication.Early cas may be a useful option for the treatment of symptomatic carotid artery stenosis.Event description: a 9-french balloon-guided catheter was introduced via the transfemoral approach.A non-mdt balloon-guided catheter was used to occlude the common carotid artery (cca), and a carotid guardwire ps was introduced into the external carotid artery (eca) to occlude its proximal portion.After the occlusion of the eca, the guiding balloon was inflated to occlude the cca and to begin the flow reversal.A non-mdt filter-wire was carefully crossed through the stenotic lesion and the filter was opened at the prepetrous portion of the ica.Blood was aspirated from the guiding catheter to remove the thrombus and the isolated plaque.The cca balloon was then deflated to restart antegrade blood flow.The diameter of the distal ica, the stenotic lesion, and the cca were measured by intravascular ultrasound (ivus).Dilation balloons were used and self-expandable stents including protege self-expandable stent were deployed.Postdilation was performed using a slightly larger balloon (4.0-5.5 mm in diameter).It was reported iatrogenic dissection occurred, procedures requiring additonal intervention and restenosis occurred.It was also reported there were incidents of hemorrhage, stoke, embolisation, hyperperfusion syndrome, transient ischaemic attack,bradycardia and hypertension during follow up.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7742615
• MDR Text Key: 115902689
• Report Number: 2183870-2018-00409
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 08/08/2018
• 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: 76 YR