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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/22; CORONARY DRUG-ELUTING STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/22; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 364504
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2024
Event Type  malfunction  
Manufacturer Narrative
Combination product: yes.
 
Event Description
An orsiro drug-eluting stent system was selected for treatment of a lesion with a stenosis degree of 90 percent.During cross over, the stent shifted from its original position but was still on the balloon.The issue was noticed and it was removed from the patient.
 
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Brand Name
ORSIRO 4.0/22
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key19154467
MDR Text Key340742404
Report Number1028232-2024-02200
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier07640130411692
UDI-Public(01)07640130411692(17)2508
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2024
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
Device Operator Health Professional
Device Model Number364504
Device Catalogue NumberSEE MODEL NO.
Device Lot Number07233180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2024
Initial Date FDA Received04/22/2024
Date Device Manufactured08/21/2023
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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