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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Rupture (2208); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Restenosis (4576)
Event Date 04/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a retrospective single-center study to evaluate efficacy of percutaneous transluminal angioplasty (pta) for the endovascular management of arteriovenous fistula (avf) dysfunction in patients with end-stage renal disease (esrd). 135 patients were included in the study who underwent endovascular treatment for a dysfunctional native avf. Medtronic¿s standard pta balloons (4-9mm) were used during the procedure to treat avf dysfunction. The balloon was maintained inflated for 2 minutes, and the procedure was repeated if necessary. Pta was technically successful in 100. 0% of operations, with residual stenosis (>30%) in 5. 2% of patients. Pta revealed clinical success in terms of adequate dialysis after the procedure in 97. 0% of patients, with complications only in 7. 4%. Complications reported include vasospasm (7 patients), ad hematoma (2 patients). Rupture is reported in 1 patient. During the follow-up period of 6 months the avf remained patent in 94 patients (median primary patency duration of 5. 0 months). Dysfunction recurrence reported in 41 patients, restenosis (7 patients) and occlusion (34 patients).
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key12121604
MDR Text Key260044632
Report Number9612164-2021-02626
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeTU
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,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
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 Received06/23/2021
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: 07/06/2021 Patient Sequence Number: 1
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