FDA.reportPublic FDA data

MAUDE MDR 9831834

MDR report key
9831834
Report number
2024168-2020-02417
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-13
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
1OMNILINK ELITEPERIPHERAL STENT DELIVERY SYSTEMABBOTT VASCULARNIO1012631-191012631-199062141R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 INDICATION OF A LOT SPECIFIC PRODUCT ISSUE. BASED ON THE INFORMATION PROVIDED, THE REPORTED DIFFICULTIES APPEAR TO BE DUE TO CASE CIRCUMSTANCES. THE FAILURE TO ADVANCE AND STENT DISLODGMENT WERE DUE TO INTERACTIONS WITH THE ANATOMY. 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 A HEAVILY CALCIFIED NON-TORTUOUS RIGHT SUBCLAVIAN ARTERY. THE 8.0X19MM OMNILINK ELITE STENT DELIVERY CATHETER FAILED TO CROSS DUE TO THE ANATOMY AND DURING REMOVAL OF THE DEVICE, THE STENT DISLODGED OUTSIDE OF THE PATIENT WHILE AT THE HUB OF THE UNSPECIFIED SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 8X17MM NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.