FDA.reportPublic FDA data

MAUDE MDR 9818269

MDR report key
9818269
Report number
2024168-2020-02259
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-11
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 VASCULARNTE22437-1922437-199080561R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-110

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 IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO DEPLOY AND POD DAMAGE. RETURN OF THE DEVICE MAY HAVE FURTHER AIDED THE ANALYSIS. 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 PROCEDURE WAS PERFORMED TO TREAT THE HEAVILY TORTUOUS, MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV6 FILTRATION ELEMENT FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND OUTSIDE OF THE PATIENT, THE DELIVERY CATHETER POD WAS NOTED TO BE TORN. A NEW SAME DEVICE WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.