FDA.reportPublic FDA data

MAUDE MDR 9758345

MDR report key
9758345
Report number
2024168-2020-01801
Event key
0
Event type
3
Date of event
2019-11-21
Date received
2020-02-26
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
1EMBOSHIELD NAV 6EMBOLIC PROTECTION SYSTEMABBOTT VASCULARNTE22438-1922438-199082061Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED FOR ANALYSIS WITH THE FILTRATION ELEMENT TORN AND THE RETRIEVAL CATHETER TORN AND SEPARATED. THE REPORTED DIFFICULTY TO INSERT COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED ONE MANUFACTURING NONCONFORMITY ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO INSERT. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING FOR THE RETURNED COMPONENTS, AN EXCEPTION HAS BEEN INITIATED TO INVESTIGATE RECENT INCIDENTS OF DIFFICULTY TO INSERT (LOAD) THE EMBOSHIELD NAV6 DEVICE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

D

Patient 1

IT WAS REPORTED THAT DURING PREPARATION OF THE EMBOSHIELD NAV6, THE FILTRATION ELEMENT FAILED TO LOAD INTO THE DELIVERY CATHETER AND THE DELIVERY CATHETER POD KINKED. THERE WAS NO PATIENT INVOLVEMENT. A NEW EMBOSHIELD NAV6 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS NOTED THE FILTRATION ELEMENT TO BE TORN AND THE RETRIEVAL CATHETER TO BE TORN AND SEPARATED.