FDA.reportPublic FDA data

MAUDE MDR 9842444

MDR report key
9842444
Report number
2024168-2020-02518
Event key
0
Event type
3
Date of event
2019-07-03
Date received
2020-03-17
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 VASCULARNIPS-60-150-120-P6S-60-150-120-P6R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. H; 2. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.