FDA.reportPublic FDA data

MAUDE MDR 9908680

MDR report key
9908680
Report number
1028232-2020-01507
Event key
0
Event type
3
Date of event
2020-01-03
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
6024 JEAN ROAD LAKE OSWEGO OR 97035 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORSIRO 2.25/30CORONARY DRUG ELUDING STENTBIOTRONIK AG, BUELACH, SWITZERLANDNIQ364511SEE MODEL NO.06181564* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A PRE-DILATED CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN MODERATELY TORTUOUS PROXIMAL CX, THE LESION COULD NOT BE CROSSED WITH THE DEVICE. A GUIDEPLUS WAS USED DURING PROCEDURE.