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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SBI060040080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Thrombus (2101)
Event Date 06/08/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure an admiral xtreme balloon catheter was used to treat the left anastomsis. Approximately 33 weeks post index procedure patient suffered shunt occlusion (avg to vein) to target vessel. A revasc was performed on the same date using a non medtronic device. The investigator has assessed event is not related to device, procedure or paclitaxel. The patient has recovered.
 
Manufacturer Narrative
The patient is a previous smoker with a medical history of hypertension, hyperlipidemia, renal insufficiency, coronary heart disease and previous revascularization of the left venous outflow. The event occurred on the (b)(6) 2018. The patient was treated with reconstruction grafting of the anastomosis. Safety assessed the event as not related to device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The patient was also treated with medication. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: it was stated that the vein near the avg was filled with thrombus. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameADMIRAL XTREME OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah # 10510
tijuana,bc 22570
MX 22570
MDR Report Key7662283
MDR Text Key113158891
Report Number9612164-2018-01618
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
Type of Report Initial,Followup,Followup,Followup
Report Date 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberSBI060040080
Device Lot Number213690261
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/04/2018 Patient Sequence Number: 1
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