• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOTRONIK AG ORSIRO CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 3.0/30/140
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
During use of the device, it was discovered while balloon was in the patient, no stent. It was first assumed the stent fell off balloon while in the patient when taking stylet out of balloon stent. Md looked for an emboli occurrence, but no embolization occurred. Looked in plastic casing and found stylet with stent on it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORSIRO
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG
6024 jean rd
lake oswego OR 97035
MDR Report Key13719993
MDR Text Key286921433
Report Number13719993
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 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number3.0/30/140
Device Catalogue Number401768
Device Lot Number6216270
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2022
Date Report to Manufacturer03/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

-
-