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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/22 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/22 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 364499
Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Combination product: yes.
 
Event Description
An orsiro drug-eluting stent system was selected for treatment of a mildly calcified lesion (90 percent stenosis degree) in a mildly tortuous distal lad. After predilatation the device was advanced to the lesion. When the balloon was inflated with nominal pressure, the pressure did not rise and blood was also observed, so it was judged that the balloon was ruptured and the catheter was removed. During withdrawal the stent has dislodged and remained in the coronary artery as confirmed by angiography. Recovery by snare was considered, but since the stent had moved slightly to distal, it was adapted to the vessel wall. A guideplus extension catheter was used during procedure.
 
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Brand NameORSIRO 2.25/22
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 Key12127096
MDR Text Key260225482
Report Number1028232-2021-03824
Device Sequence Number1
Product Code NIQ
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 company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2021
Device Model Number364499
Device Catalogue NumberSEE MODEL NO.
Device Lot Number07195707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2019
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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