(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The reported patient effect(s) of pain and thrombosis are listed in the xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The supera and xience prime 3.0x33, are filed under separate medwatch manufacturer report reference numbers.
|
It was reported that the patient underwent a procedure, with implantation of one supera self-expanding stent and two xience prime below the knee (btk) stents.The supera was implanted in the popliteal artery, with the xience prime btk stents implanted in a kissing fashion in the tibioperoneal trunk and the anterior tibial artery all on (b)(6) 2017.That evening, the patient complained of numbness and pain in his foot.Computed tomography angiography (cta) showed complete thrombosis from the distal superficial femoral artery down to the xience prime (3.0 x 38 mm and 3.0 x 33 mm) stents.The supera had thrombosed mid-stent causing both xience prime stents to block as well.Aspiration thrombectomy with short thrombolysis was performed on (b)(6) 2017.The patient had prolonged hospitalization and was treated with overnight lysis.Patient was discharged on (b)(6) 2017.No additional information was provided.
|