As the lot number for the device was not provided, a manufacturing review could not be performed.
The sample was not returned to the manufacturer for inspection/evaluation.
Therefore, the investigation of the reported event is inconclusive.
Based upon the available information, the definitive root cause for this event is unknown.
The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.
Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Journal article citation: chen, j.
X.
, levin, l.
S.
, mantell, m.
P.
, redmond, j.
W.
, & clark, t.
W.
I.
(2019).
Endovascular therapy for below-the-elbow arterial disease: an initial single-center experience.
Journal of endovascular therapy, 26(4), 505¿511.
Doi: 10.
1177/1526602819854167.
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It was reported in an article from the journal of endovascular therapy titled " endovascular therapy for below-the-elbow arterial disease: an initial single-center experience " that complications were observed in a retrospective review of the 19 patients who underwent angioplasty for critical limb ischemia.
Postangioplasty, there were 3 access site hematomas and one perforation in the axillary artery, which resolved with balloon tamponade.
Rethrombosis of the radial artery within hours of endovascular revascularization due to postprocedural heparin not being initiated appropriately; the patient underwent subsequent successful surgical thrombectomy.
A technical failure was observed in 3 procedures; the patient underwent subintimal recanalization using a variety of crossing devices, however, reocclusion occurred in 3 weeks later.
The status of the patients was not provided.
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