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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/15; CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.75/15; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 401743
Device Problem Use of Device Problem (1670)
Patient Problem Vascular Dissection (3160)
Event Date 06/01/2020
Event Type  Injury  
Event Description
An orsiro drug-eluting stent system was chosen for treatment.Patient underwent a heart catheterization due to an nstemi.The stent was placed to om1, culprit lesion.A small dissection was noted after implantation.Another osiro stent was placed to dissected area distal to initial stent, however overlapping.Patient was stable throughout the procedure and overnight and was discharged home.
 
Manufacturer Narrative
17-aug-2020 - this report was opened in error.The lot number is incorrect.The correct lot number is 05193862, which was reported on mdr-1028232-2020-03248.Closing this report.
 
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Brand Name
ORSIRO (US) 2.75/15
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 Key10393632
MDR Text Key202507085
Report Number1028232-2020-03355
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier07640130438989
UDI-Public07640130438989
Combination Product (y/n)N
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/02/2020
Device Model Number401743
Device Catalogue NumberSEE MODEL NO.
Device Lot Number11184278
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received08/11/2020
Supplement Dates Manufacturer Received07/13/2020
Supplement Dates FDA Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age63 YR
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