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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 SBI050040080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one medtronic standard pta was used to treat the anastomosis of the left limb. Approximately 14 months post index procedure, avf stenosis was reported. This was treated with medication and revascularization of the anastomosis using a non-medtronic pta. The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel medication. The patient recovered.
 
Manufacturer Narrative
The patient is a previous smoker and has a medical history of hypertension, hyperlipidemia, diabetes, renal insufficiency, pad, and previous revascularisation of the anastomosis. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Lot number of device used during index procedure provided. 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
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 
091708734
MDR Report Key8167780
MDR Text Key130464343
Report Number9612164-2018-03636
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K173515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberSBI050040080
Device Lot Number213501583
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 Received05/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2017
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: 12/16/2018 Patient Sequence Number: 1
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