FDA.reportPublic FDA data

MAUDE MDR 9908663

MDR report key
9908663
Report number
1028232-2020-01505
Event key
0
Event type
3
Date of event
2020-02-27
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
1PK PAPYRUS US 4.0/20COVERED CORONARY STENTBIOTRONIK AG, BUELACH, SWITZERLANDNIV434896SEE MODEL NO.09192030* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H

Event Narratives#

D

Patient 1

A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATED VESSEL. 2 TO 3 HOURS AFTER TREATMENT PATIENT WAS IN TAMPONADE. DRAINS WERE INSERTED TO RELIEVE PRESSURE. BALLOONED PROXIMAL AREA WAS STILL LEAKING. THE PK PAPYRUS 4.0/20 WAS DEPLOYED, STILL SOME LEAKAGE AND IT WAS CONTINUED TO DRAIN. PATIENT WAS DISCHARGED HOME NEXT DAY AND IS WELL.