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 Occlusion (1984)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Online journal article title: the effect of stent cell geometry on carotid stenting outcomes b.Alparslan et al.Cardiovasc intervent radiol (2016) 39:507¿513.

Event Description

Carotid artery stenting (cas) is an alternative treatment method in preventing carotid artery-related ischemic stroke.Carotid stents have different behaviors due to their designs.Ideal stent characteristics may be defined as scaffolding, elasticity, and adaptability to the vessel wall.The ideal stent should have better scaffolding potential.The best elasticity and adaptability to the vessel wall can be provided by an open-cell design, but open structure with large free cell area allows particle efflux.On the other hand, closed-cell design is less flexible and thus less adaptable to the vessel wall, but more resistant to particle efflux and has high scaffolding potential.There are several studies investigating the effect of stent design on periprocedural events and usefulness of doppler ultrasonography (dus) to detect the rate of stenosis of cas.However, there are not much study concerning about midterm and long-term and usefulness of computed tomography angiography (cta) to detect restenosis.The aim of this study was to investigate the effect of stent cell geometry on midterm clinical outcomes of cas and detect restenosis rates with cta.One hundred fifty-five patients (118 men, 37 women; mean age 64 ± 8 years) were retrospectively enrolled between february 2010 and december 2012.In total 175 procedures were accomplished (132 procedures in 118 men and 43 procedures in 37 women).A contralateral stent was placed in 20 of these patients.Ninety-one (52 %) of stents were open-cell design (protege) and 84 (48 %) were closed-cell (xact).Diagnostic catheters were changed via 8 f envoy (cordis, (b)(4)) and march 1 (boston scientific, (b)(4)) guiding catheters and 90 cm 6¿7 f destination (terumo, (b)(4)) guiding sheaths.Emboshield (abbott laboratories, (b)(4)) and spider rx (ev3, (b)(4)) distal emboli protection devices (epds) were used.Predilatation was performed with low profile balloon (3 9 20 mm) for preocclusive stenosis.Self-expandable stent was placed to the stenotic segment.To achieve adequate stent expansion postdilatation was performed in all patients with pta balloons (5 9 20 or 6 9 20 mm).Ninety-one (52 %) open-cell protege (ev3, (b)(4)) and 84 (48 %) closed-cell xact (abbott laboratories, (b)(4)) self-expandable nitinol stents were implanted for internal carotid artery (ica) and common carotid artery (cca) stenoses.Angiographic controls were made after the procedure to evaluate embolic events and st ent clearance.Eleven complications were encountered in the periprocedural period (four on the open- and seven on the closed-cell group).Total complication rate was 6.3 % (11/175).Perioperative complication rate was 5.9 % (8/136) in symptomatic patient group and 7.7 % (3/39) in asymptomatic patient group.No significant difference was detected in terms of periprocedural complications between two groups (p = 0.643).Acute angiographic results like plaque protrusion, residual stenosis or a lack of stent integrity or apposition were not observed in both stent groups.No minor or major complication happened during the femoral access.Access site hemostasis was ensured with starclose vascular closure system (abbott vascular, (b)(4)) or manual compression.One hundred and sixty-seven epds were used in 175 procedures.Epd was not used in eight procedures because of severe stenosis and seven of them did not have any complications.Five of six patients who got tia or stroke during the periprocedural period had epds.No significant difference was detected in terms of periprocedural complications between predilatation performed (41 procedures) and primary stenting performed (134 procedures) groups (p = 1.000).Restenosis in 118 stents, 16 open-cell stents, and three closed-cell stents had focal isr.One closed-cell stent had diffuse proliferative isr and one open-cell stent had total occlusion.There was significant statistical difference between two groups (p = 0.002).These data suggest that more intimal hyperplasia develops in open-cell stents during follow-up period compared to closed-cell stents.The threshold for restenosis was accepted to be [70 % narrowing and our restenosis rate was 0.7 % (1/139).Statistical comparison of groups could not be done because of low restenosis rates.The mean time period between stenting procedure and radiological follow-up was 15 months (min¿max: 6¿39) in the group without restenosis and 18 months (6¿39) in the group with restenosis.Follow-up period had no significant effect on alterations of stents (p = 0.877).Forty-three patients were excluded clinically (31 patients did not attend to their clinical controls, four died on the periprocedural period, one died because of vascular and seven because of non-vascular reasons).

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: 5744229
• MDR Text Key: 48000117
• Report Number: 2183870-2016-00415
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• 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: 05/24/2016
• 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: 64 YR