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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN INTRASTENT LD; CATHETER, BILIARY, DIAGNOSTIC

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COVIDIEN INTRASTENT LD; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Occlusion (1984)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
Study title factors affecting the results of superficial femoral artery stenting mark kay, md, bsc, frcs; radu rogoveanu,md;, james hodson, bsc; simon tallowin, msc, mrcs; jonathan hopkins, bmbs, frcr; martin duddy, ebir; and rajiv vohra, phd, frcs vascular and endovascular surgery 2015, vol.49(8) 228-235 ª the author(s) 2015 reprints and permission: sagepub.Com/journalspermiss ions.Nav doi: 10.1177/1538574415614405 ves.Sagepub.Com downloaded from ves.Sagepub.Com at copyright clearance center on april 27, 2016.
 
Event Description
Event found from review of literature.Introduction: the aim of this study was to assess the durability of superficial femoral artery (sfa) stents and factors that affect stent patency.Methods: a retrospective assessment of 214 sfa stent procedures between 2003 and 2012 was conducted from a prospectively compiled database.Patency rates and patient outcomes were compiled from case notes and computerized records.Stent patency was confirmed by either duplex scan or clinical examination (palpable distal pulse).Survival and patency were compared across a range of factors using kaplan-meier plots and log-rank tests.Factors found to be significant were further assessed by cox regression models.Results: data were analyzed for 214 limbs in 205 patients.Inclusion criteria included those patients who received an sfa stent for treatment of claudication or critical limb ischemia (cli) with follow-up data.This gave a study group of 151 limbs divided into 76 claudicant and 75 patients with cli (male¿female ratio = 103:48, mean age 71 years, standard deviation 11.7).Seventy-one percent of procedures were elective and 29% were emergency procedures; 53% of procedures were carried out on a day case basis.Median follow-up was 11 months (range 1 day- 89 months).Patency was significantly worse for patients with cli (p =.009), with a 1- and 3-year patency of 63% and 34% compared to 79% and 60% in patients with claudication.Significant factors associated with patency included oral therapy controlled diabetes (p =.003), lesions located in either the mid-sfa (p =.029) or the mid-popliteal (p =.013), and periprocedural complications (p =.005).There was no significant difference in patency rates between insulin-dependent and nondiabetic patients (hazard ratio: 1.0, 95% confidence interval: 0.4-5.6, p =.983).The overall amputation rate for the total study group was 5%.Patients with 1- and 3-year survival were 98% and 96% in the claudication group and 74% and 51%, respectively, in the cli group.Conclusion: sfa stents have superior outcomes in claudicants.Patency is related to severity of disease, diabetes, and location of disease.Data were analyzed in 205 patients.Nine patients underwent bilateral procedures, giving a total of 214 limbs treated.Data were analyzed in 205 patients.Nine patients underwent bilateral procedures, giving a total of 214 limbs treated.Of these, 167 (78%) limbs met the inclusion criteria for the study with 76 claudicants and 75 patients with cli (figure 1).Indication for stent insertion included recoil post-angioplasty (69%; figure 2a-c), primary stent (14%), restenosis (14%), vessel rupture (1.5%), and dissection (1.5%).There was no significant difference in indications for stenting between the 2 groups (p ¼.237).Seventy-one percent of the procedures were carried out on an elective basis, 29% were emergency procedures, 58% of the procedures were carried out on a day case basis, and 42% with an inpatient stay.There was a greater preponderance of male patients (68% male and 32% female), with a mean treatment age of 71.3 years (standard deviation 11.7).Median followup was 11 months (range: 1 day-89 months).Baseline patient demographics revealed commonly known risk factors for vascular disease of smoking, hypertension, hypercholesterolemia, and diabetes (table 1).In all, 52% of lesions treated were chronic total occlusions and the remaining 48% were for stenotic lesions.There were 11 different stent types used during the study period (table 1).Self-expanding stents (95%) were more commonly deployed than balloon expanding stents (5%).In all, 63% of stents were deployed in an intraluminal fashion compared to 37% via a subintimal route.Complications following the procedure included embolus (11%), vessel perforation (4%), groin hematoma (3%), worsening of ischemia (2%), target vessel thrombosis (3%), device malfunction (1%), and flow-limiting dissection (1%).Five patients underwent thrombolysis following stent insertion, and 5 patients required thromboaspiration.There was no significant difference in the complication rate between patients treated for claudication or cli (p ¼.097).Forty-nine (33%) patients occluded their stents during the study period.Of these patients, 8 (16%) underwent major amputation of which 2 patients had a bypass procedure that subsequently failed (1 patient in each group), 23 (47%) patients underwent open surgical bypass procedure, while 18 (37%) patients were managed conservatively.The overall amputation rate for the total study group was 5%.In all, 15% of the study group underwent surgical bypass after stent occlusion.Thirty one (21%) patients died during the study period, with 71% of these deaths occurring within 2 years.Upon comparing the 2 study groups, more than a third of the patients with cli died during the study period, reflecting cardiovascular risk of these patients (figure 3).Of those alive, 64% occluded their stent, half of which were managed with a bypass procedure.Six patients required major amputation (one of these patients had a bypass initially that subsequently occluded).Only 3 patients died in the claudication group (figure 4), and a quarter of patients occluded their stents during the study period.The majority of these were managed with bypass.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
INTRASTENT LD
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
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 Key5751902
MDR Text Key48255350
Report Number2183870-2016-00485
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K020528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
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 Received05/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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