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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 Reocclusion (1985); Pain (1994); Stenosis (2263); Pseudoaneurysm (2605)
Event Date 12/06/2017
Event Type  Injury  
Manufacturer Narrative

Majority age and gender. Event date is literature article published date journal: ann vasc surg 2018; 48: 79¿88. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Purpose: the purpose of the study was to present a new alternative balloon catheter option for autogenous arteriovenous fistula (avf) dysfunction with a stiff constriction resistant to conventional balloon angioplasty. Event: a medtronic admiral xtreme balloon was expanded at the stenosis site with a pressure buildup to its working pressure. The balloon catheter could not be fully expanded at the site of stenosis, as manifested by a ¿¿thin-waist¿¿ (residual stenosis) sign. Then, the balloon continued to be dilated to its preset burst pressure. At this time, most patients complained of severe wrist pain, and a visual analog scale (vas) was supplied for each patient on which they marked the point that represented their perception of their current state. The stenosis was too difficult to successfully widen and subsequent angiography showed evidence of >30% residual stenosis; therefore, the treatment standard was not met. A vascutrak balloon was used to complete the procedure. At follow up, reoccurrence of occlusion and restenosis were reported. Re intervention was performed for these cases in the form of - surgical excision, reconstruction of a new fistula and recanalization. One case of a brachial artery pseudoaneurysm complication occurred in the perioperative period. Conclusion: the use of vascutrak balloon catheter to treat autogenous avf dysfunction resistant to conventional balloon angioplasty appears to be safe and effective, although further, large randomized controlled trials are necessary.

 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7585927
MDR Text Key110572801
Report Number9612164-2018-01378
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 06/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
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: 06/11/2018 Patient Sequence Number: 1
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