FDA.reportPublic FDA data

MAUDE MDR 9835538

MDR report key
9835538
Report number
2024168-2020-02455
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-16
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
1SUPERA PERIPHERAL STENT SYSTEMSELF EXPANDING PERIPHERAL STENT SYSTEMABBOTT VASCULARNIP42055200-0809080861R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1661. H; 2. R; 3. S

Event Narratives#

N

Patient 1

THE STENT IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER SUPERA IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#.

D

Patient 1

IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). ABOUT 4 MONTHS AGO, THE PATIENT HAD A NON-ABBOTT STENT IMPLANTED WHICH WAS MASSIVELY OVER DILATED TO 7MM. THE ENDS HAD CRIMPED SLIGHTLY, AND THE STENT BECAME OCCLUDED. ON (B)(6) 2020, THE VESSEL WAS PREPARED USING A 6-FRENCH NON-ABBOTT ATHERECTOMY DEVICE AND A 5.5X200MM ARMADA 18 BALLOON. DURING DEPLOYMENT OF THE 5.5X200MM SUPERA STENT, THE STENT BECAME DAMAGED (ASSUMED TO BE INVAGINATED) AS IT REACHED THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN STOPPED THE DEPLOYMENT AND PULLED BACK SLIGHTLY TO ALLOW THE STENT TO GET BACK TO NORMAL BUT WAS UNSUCCESSFUL AS THE STENT BECAME STUCK WITH THE SHEATH. AFTER SOME PULLING, THE STENT FULLY DEPLOYED. THE STENT WAS NOTED TO BE SHORT AND THEREFORE A SECOND SAME SIZE SUPERA STENT WAS DEPLOYED OVERLAPPING THE FIRST SUPERA STENT IN THE PROXIMAL SFA. IMAGES OF THE SECTION OF THE DAMAGED STENT DID NOT LOOK GREAT AND WAS TREATED WITH POST-PLASTY HOWEVER IT REMAINED THE SAME. BLOOD FLOW WAS BRISK BUT WITHIN 24 HOURS, BOTH SUPERA STENTS HAD OCCLUDED. AN ABOVE KNEE BYPASS PROCEDURE WAS DONE ON (B)(6) 2020. ONLY THE DAMAGED SUPERA STENT (THE FIRST IMPLANTED) WAS EXPLANTED AND IT WAS THEN CONFIRMED THAT THE STENT WAS TWISTED ON ITSELF AND COMPLETELY DISTORTED IN CERTAIN AREAS AND NOT INVAGINATED AS PREVIOUSLY THOUGHT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.