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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/22; CORONARY DRUG-ELUTING STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/22; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 419128
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
Combination product: yes.
 
Event Description
An orsiro mission drug-eluting stent system was selected for the treatment of a lesion in the lca.After successful stent deployment it was not possible to deflate the delivery balloon.After special maneuvers (replace two new indeflators, exchange the wire) the balloon was successfully deflated and the procedure could be continued.
 
Manufacturer Narrative
Combination product: yes.Opened in error.Report was on a different device.Correct device reported on mdr-1028232-2021-00746.Closing this report.
 
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Brand Name
ORSIRO MISSION 3.0/22
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key11266460
MDR Text Key229860593
Report Number1028232-2021-00576
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2022
Device Model Number419128
Device Catalogue NumberSEE MODEL NO.
Device Lot Number12190933
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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