• 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, BUELACH, SWITZERLAND ORSIRO 3.5/40 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, BUELACH, SWITZERLAND ORSIRO 3.5/40 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 391020
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Event Description
An orsiro drug-eluting stent system was selected for treatment of a total occlusion in the rca. A stent was implanted and post stent dilated but it there was no flow. Then the orsiro was selected for stent placement, but it could not pass and was removed. After re-insertion and using a guideplus, it was noticed that the stent was not crimped on the balloon. The stent system and guideplus were withdrawn. It was noticed that the stent was displaced on the shaft of the delivery system.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORSIRO 3.5/40
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 Key13122182
MDR Text Key283175577
Report Number1028232-2021-06998
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
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 Number391020
Device Catalogue NumberSEE MODEL NO.
Device Lot Number06216019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-