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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/26; CORONARY DRUG-ELUTING STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/26; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 364508
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Combination product: yes.
 
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.After the removal of the protection cap for the stent, the stent system was inserted into a patient.Stent position could not be confirmed under angiography.Stent was detected to be dislodged from the delivery system outside patient.
 
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Brand Name
ORSIRO 3.0/26
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key10929539
Report Number1028232-2020-05223
Device Sequence Number11380001
Product Code NIQ
UDI-Device Identifier07640130439177
UDI-Public7640130439177
Combination Product (Y/N)Y
Initial Reporter CountryCH
PMA/510(K) Number
P170030
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/27/2022
Device Model Number364508
Device Catalogue NumberSEE MODEL NO.
Device Lot Number01201568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Initial Date Received by Manufacturer 11/27/2020
Supplement Date Received by Manufacturer01/12/2021
Initial Report FDA Received Date12/01/2020
Supplement Report FDA Received Date01/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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