FDA.reportPublic FDA data

MAUDE MDR 9813466

MDR report key
9813466
Report number
2024168-2020-02232
Event key
0
Event type
3
Date of event
2020-02-14
Date received
2020-03-10
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
1GRAFTMASTERCORONARY STENT DELIVERY SYSTEMABBOTT VASCULARMAF1012580-161012580-169032541R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1001. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT APPEAR 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 THE PATIENT UNDERWENT A CORONARY PROCEDURE. DURING USE OF AN UNSPECIFIED DEVICE, A PERFORATION OCCURRED IN THE CIRCUMFLEX ARTERY. THE 2.8 X 16 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY, THE GRAFTMASTER WAS UNABLE TO CROSS. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUE. THE PERFORATION WAS SEALED WITH PROLONGED BALLOON INFLATIONS. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.