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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/13
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.75/13 Back to Search Results
Model Number 419109
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 10/18/2020
Event Type  Injury  
Manufacturer Narrative
Combination product: yes.
 
Event Description
On (b)(6) 2020, two orsiro mission stents were successfully implanted into mid lad.On (b)(6) 2020 patient admitted as emergency case.Stemi was discovered and treated successfully with des into the lad.In the further course the patient showed recurrent broad complex tachycardias with hemodynamic collapse, which could only be controlled with sedacoron.Increasing hemodynamic deterioration as cardiogenic shock, patient died with cardiovascular failure on (b)(6) 2020.The second orsiro mission stent is reported separately.
 
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Brand Name
ORSIRO MISSION 2.75/13
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key11529188
MDR Text Key241051552
Report Number1028232-2021-01311
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/23/2021
Device Model Number419109
Device Catalogue NumberSEE MODEL NO.
Device Lot Number08195918
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2021
Date Device Manufactured09/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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