Model Number A35SX050120135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Reocclusion (1985)
|
Event Date 05/08/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The patient weight is unknown.This information was not available from the facility.The patient required revascularization of the target lesion.This is being reported as a follow-up to the clinical registry.Cross reference mfr report numbers: 3009784280-2019-00685, 3009784280-2019-00686, 3009784280-2019-00687, 3009784280-2019-00688.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign- (b)(6)/ study name: (b)(6): patient id (b)(6).Pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Per the ifu, restenosis is listed as a potential complications/adverse events.
|
|
Event Description
|
It was reported through a clinical registry that during the index procedure on (b)(6) 2019, 4 stellarex catheters were used to treat the target lesion of the left proximal, mid, distal sfa, popliteal p1, p2.Approximately 1 month post index procedure, the patient experienced restenosis.A successful revascularization of the target lesion was performed on (b)(6) 2019.
|
|
Search Alerts/Recalls
|
|