FDA.reportPublic FDA data

MAUDE MDR 9891623

MDR report key
9891623
Report number
2024168-2020-03051
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-27
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
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AV RX GRAFTMASTERCORONARY STENT DELIVERY SYSTEMABBOTT VASCULARMAF1012580-261012580-268103141R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

D

Patient 1

IT WAS REPORTED THAT THIS WAS A CORONARY PROCEDURE TO TREAT A PERFORATION IN THE HEAVILY CALCIFIED, RIGHT CORONARY ARTERY. A NON-ABBOTT COVERED STENT WAS INSERTED AND WAS UNABLE TO CROSS THE LESION. THE 2.8 X 26 MM GRAFTMASTER STENT WAS INSERTED, BUT WAS ALSO UNABLE TO CROSS THE LESION DUE TO THE HEAVY CALCIUM. THE HEPARIN WAS REVERSED WITH PROTAMINE MEDICATION AND MULTIPLE PROLONGED BALLOON INFLATIONS WERE PERFORMED WHICH SEALED THE PERFORATION. THE PATIENT RECOVERED. THERE WAS NO ADVERSE SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.