SUPERA PERIPHERAL STENT SYSTEM 42065100-120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for SUPERA PERIPHERAL STENT SYSTEM 42065100-120 manufactured by Abbott Vascular.

Event Text Entries

[185728652] 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 other similar incidents and/or complaints from this lot. Based on the information provided, a definitive cause for the difficulties could not be determined. It may be possible that the vessel diameter was narrowed in some locations causing the stents to elongate during deployment; however, this could not be confirmed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional supera device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10


[185728653] It was reported that the procedure was performed to treat a lesion in the popliteal artery and femoral artery. Following pre-dilatation, a 6. 5x200mm supera self-expanding stent (ses) was deployed in the popliteal artery and 6. 5x100mm supera ses were deployed in the femoral artery; however, they seemed to be longer than the size on the label. The 6. 5x200mm ses measures around 300mm post-deployment and the 6. 5x100mm ses measures around 180mm post-deployment, both stents elongated more than 10%. Both sess were removed under fluoroscopy. The procedure was successfully completed with no consequence to the patient. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03045
MDR Report Key9890973
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-13
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-08-12
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERA PERIPHERAL STENT SYSTEM
Generic NameSELF EXPANDING PERIPHERAL STENT SYSTEM
Product CodeNIP
Date Received2020-03-27
Catalog Number42065100-120
Lot Number9081261
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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