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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK INC. ORSIRO CORONARY DRUG-ELUTING STENT

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BIOTRONIK INC. ORSIRO CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 2.75/30/140
Device Problems Collapse (1099); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 02/04/2021
Event Type  malfunction  
Event Description
Stent did not cross lad lesion. When stent was removed, it was noticed that the sides of the stent were collapsed and deformed at the proximal end.
 
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Brand NameORSIRO
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK INC.
6024 jean road
lake oswego OR 97035
MDR Report Key11515154
MDR Text Key240625419
Report Number11515154
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2.75/30/140
Device Catalogue NumberREF # 401767
Device Lot Number06200283
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/15/2021
Event Location Hospital
Date Report to Manufacturer03/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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