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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 391020
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/05/2020
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 of a moderately calcified lesion (90 percent stenosis degree).When inserting the device into the guiding catheter the stent dislodged from the balloon just outside the y adapter outside of the patient.
 
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Brand Name
ORSIRO 3.5/40
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 Key10960111
Report Number1028232-2020-05327
Device Sequence Number16941125
Product Code NIQ
UDI-Device Identifier07640130439450
UDI-Public07640130439450
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) 12/04/2020
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 Date05/02/2021
Device Model Number391020
Device Catalogue NumberSEE MODEL NO.
Device Lot Number04192880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Initial Date Received by Manufacturer 12/04/2020
Supplement Date Received by Manufacturer01/08/2021
Initial Report FDA Received Date12/07/2020
Supplement Report FDA Received Date01/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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