FDA.reportPublic FDA data

MAUDE MDR 9898103

MDR report key
9898103
Report number
2134265-2020-03787
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNERGYBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEMBOSTON SCIENTIFIC CORPORATIONNIQ10610106100023634067R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. R

Event Narratives#

N

Patient 1

DEVICE IS A COMBINATION PRODUCT.

D

Patient 1

IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS LOCATED IN THE VESSEL AND WAS SUBSEQUENTLY CRUSHED AND SECURED BY A NEW STENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT WAS DISCHARGED.