Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) 2.25/13; 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) 2.25/13; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 401735
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/10/2020
Type of Reportable Event Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.The lesion could not be crossed and the device was removed.When the device was ready to load again it was discovered that there was no stent on the balloon.The stent was found in the co-pilot hemostatic valve.
 
Additional Manufacturer Narrative
Combination product: yes.On 29-oct-2020 - opened in error--incorrect lot and size.Opened new report: mdr-1028232-2020-04710.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORSIRO (US) 2.25/13
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key10404929
Report Number1028232-2020-03420
Device Sequence Number14187504
Product Code NIQ
UDI-Device Identifier07640130438903
UDI-Public07640130438903
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P170030
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/07/2021
Device Model Number401735
Device Catalogue NumberSEE MODEL NO.
Device Lot Number03196537
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/11/2020
Supplement Date Received by Manufacturer10/29/2020
Initial Report FDA Received Date08/13/2020
Supplement Report FDA Received Date10/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age65 YR
-
-