ORSIRO (US) 3.0/35 404669 SEE MODEL NO.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for ORSIRO (US) 3.0/35 404669 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.

Event Text Entries

[185940300] An orsiro drug-eluting stent system was chosen for treatment of a svg. The device could not be advanced through a 6f guideliner and was removed. After removal it was detected that the stent was deformed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1028232-2020-01504
MDR Report Key9908661
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-10
Date Mfgr Received2020-03-12
Device Manufacturer Date2018-11-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street6024 JEAN ROAD
Manufacturer CityLAKE OSWEGO OR 97035
Manufacturer CountryUS
Manufacturer Postal97035
Manufacturer Phone8772459800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORSIRO (US) 3.0/35
Generic NameCORONARY DRUG-ELUTING STENT
Product CodeNIQ
Date Received2020-03-31
Model Number404669
Catalog NumberSEE MODEL NO.
Lot Number10186924
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOTRONIK AG, BUELACH, SWITZERLAND
Manufacturer AddressACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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