SUPERA PERIPHERAL STENT SYSTEM S-60-150-120-P6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-17 for SUPERA PERIPHERAL STENT SYSTEM S-60-150-120-P6 manufactured by Abbott Vascular.

Event Text Entries

[186734612] Dates of event and implant: estimated dates. The device was not returned for analysis as the stent remains in the patient. The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported. The reported patient effect of restenosis is listed in the supera instructions for use as a known potential patient effect. Based on the reported information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. The surgical procedure was related to case circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. Literature attachment: pathology and multimodality imaging of acute and chronic femoral stenting in humans. The other supera referenced in the article as case six is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10


[186734613] It was reported that the 6. 0x150 mm supera stent was implanted in the superficial femoral artery. 385 days after the stent procedure, the patient had in-stent restenosis. This supera stent was obtained after an autopsy. This was a patient referenced as case 10 in the article titled, pathology and multimodality imaging of acute and chronic femoral stenting in humans.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02518
MDR Report Key9842444
Report SourceLITERATURE
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-07-03
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-17
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 Received2020-03-17
Model NumberS-60-150-120-P6
Catalog NumberS-60-150-120-P6
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
101. Hospitalization; 2. Required No Informationntervention 2020-03-17

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