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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Hemorrhagic Stroke (4417); Restenosis (4576)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: comparison of long term outcomes after endovascular treatment versus bypass surgery in chronic limb threatening ischaemia patients with long femoropopliteal lesions eur j vasc endovasc surg (2021) 61, 258e269 european society for vascular surgery. Published by elsevier b. V. All rights reserved. Https://doi. Org/10. 1016/j. Ejvs. 2020. 11. 009. Age or date of birth: average age. Sex: majority gender. Date of event: date available online. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Objective: there are currently two treatments available for patients with chronic limb threatening ischaemia (clti): open surgical bypass (osb) and percutaneous transluminal angioplasty with/without stenting (pta/s). The aim of this study was to compare short and long term outcomes between pta/s and osb in clti patients with long (glass grade iii and iv) femoropopliteal disease. Methods: this was a two centre retrospective study including all consecutive patients with clti undergoing first time lower extremity intervention at two distinct vascular surgical centres. Between 1 january 2012 and 1 january 2018, 1 545 clti consecutive limbs were treated for femoropopliteal glass grade iii and iv lesions at two vascular surgical centres. Using covariables from baseline and angiographic characteristics, a propensity score was calculated for each limb. Thus, comparable patient cohorts (235 in pta/s and 235 in osb group) were identified for further analysis. The primary outcomes were freedom from re-intervention in the treated extremity and major amputation. Secondary outcomes were all hospital complications among the two patient groups. Results: total overall complication rates were significantly higher in the osb group (20. 42% vs. 5. 96%, p <(><<)>. 001), especially wound infection/seroma rate that required prolonged hospitalisation and further treatment (7. 65% vs. 0%, p <(><<)>. 001). After the median follow up of 61 months, re-intervention rates were significantly higher in the pta/s group (log rank test, 44. 68% vs. 29. 79%, p ¼. 002), but there was no significant difference in terms of major amputation rates between the two group of patients (log rank test, pta/s 27. 23% vs. Osb 22. 13%, p ¼. 17). Conclusion: bypass surgery seems to be superior to pta/s for glass grade iii and iv femoropopliteal lesions in patients with clti in terms of long term re-intervention rates, but with considerably higher rates of postoperative complications. A larger cohort of patients in currently ongoing randomised trials, as well as prospective cohort studies are necessary to confirm these findings.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11539871
MDR Text Key241376740
Report Number9612164-2021-01073
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2021 Patient Sequence Number: 1
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