• 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 (US) 2.75/40 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 (US) 2.75/40 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 404674
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
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 a moderately tortuous proximal lad and an isr in the distal lad. After pre-dilatation an orsiro stent was successfully implantation in the proximal lad. The second orsiro 2. 75/40 was selected to treat the distal isr but could not pass through the already implanted stent and it was decided to remove it for further balloon dilatations. Since the balloon could not pass it was decided that the lesion was too tight and the guidewire was removed. During the control angio it was noticed that the stent has been dislodged from the balloon by getting caught at the guiding catheter. The physician tried to remove the stent with a snare. The patient was sent to cv surgery. The patient was finally doing fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORSIRO (US) 2.75/40
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 Key13122155
MDR Text Key283175484
Report Number1028232-2021-06989
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
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number404674
Device Catalogue NumberSEE MODEL NO.
Device Lot Number06216272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
-
-