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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 UNK-CV-GWY-SBI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Pneumothorax (2012)
Event Date 10/01/2018
Event Type  Death  
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 left venous outflow. Approximately 13 months post procedure, the patient expired.
 
Manufacturer Narrative
Patient has a medical history of diabetes and renal insufficiency. During the index procedure one admiral xtreme pta was used. Approximately 6 months post procedure the patient suffered pneumothorax which led to death. Investigator and sponsor assessed the pneumothorax event as not related to the device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the cec adjudicated the death as not related to the device, procedure or paclitaxel. 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 Key8454989
MDR Text Key139951359
Report Number9612164-2019-01052
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberUNK-CV-GWY-SBI
Device Lot Number213636745
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 Received05/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2017
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: 03/27/2019 Patient Sequence Number: 1
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