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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 391239
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
An orsiro drug-eluting stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree) in the mildly tortuous mid lad. The orsiro stent could not pass the lesion and got caught inside. Thus, it was decided to add a guideplus ii and tried to pass through the lesion but the orsiro stent dislodged from the balloon inside the guideplus ii. The device was removed and another stent was used to complete the intervention.
 
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Brand NameORSIRO 2.5/40
Type of DeviceCORONARY 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 Key13122152
MDR Text Key283175814
Report Number1028232-2021-06990
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number391239
Device Catalogue NumberSEE MODEL NO.
Device Lot Number05215184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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