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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 Pulmonary Embolism (1498); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Asystole (4442)
Event Date 11/27/2020
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 comparison between patients with high-risk pulmonary embolism (pe) treated with catheter-directed intervention (cdi) plus anticoagulation and patients treated with anticoagulation (ac) only as used before the cdi technique was available. The main predefined outcomes of interest were survival to 90 days and reduction of rv/lv ratio. 22 patient¿s were included in the cdi group and 23 in the ac group. Medtronic¿s admiral xtreme was identified as a non-compliant balloon used for initial mechanical fragmentation. 14 of the 22 patient¿s in the cdi group were treated with a balloon catheter. Three eligible patients were excluded because the scheduled treatment by cdi was never initiated; two of them improved hemodynamically prior to the intervention, which was consequently inhibited, and one patient succumbed due to circulatory shock before the start of the intervention. Two patients were subjected to surgical thrombectomy due to recurrent pe shortly after cdi; one of them died after 10 days and the other one was still alive after one year. One patient reacted to rheolytic fragmentation with an episode of asystole and another patient displayed repeated bouts of hypotension due to failing right heart performance. No bleeding complications occurred. No patient received rescue thrombolysis after the completed cdi. The procedure was classified as clinically successful in all except three patients who succumbed to circulatory shock unrelated to the intervention and in two patients who died due to irreversible shock in the icu within a few hours after the intervention. Ninety-day survival was 59% after cdi. Among the nine non-survivors in the cdi group, causes of death were pe in eight and cerebral infarction with herniation in one patient. There is no established or suspected causal relationship between the device(s) and the death events.
 
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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 Key12197298
MDR Text Key262474811
Report Number9612164-2021-02797
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSW
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
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
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 Received07/19/2021
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: 07/20/2021 Patient Sequence Number: 1
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