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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Edema (2020)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: event date: date of article publication. Pulmonary artery stenting in a patient with takayasu¿s arteritis using a novel balloon-expandable covered stent sage open medical case reports (2019), (7) 1-3. 10. 1177/2050313x19841955. If information is provided in the future, a supplemental report will be issued.
Event Description
Patient with takayasu¿s arteritis was admitted with left sided pneumonia after a several year history of exertional dyspnea. A ct angiogram was obtained and revealed severe stenosis of the right main pulmonary artery (pa), resulting in marked reduction in blood flow to the right lung. Echocardiography demonstrated normal left ventricular (lv) function, moderate tricuspid regurgitation and estimated pa pressure of 62 mmhg. To minimize the risk of pa rupture, we planned to use a non-medtronic balloon-expandable covered stent as definitive treatment. Due to the risk of post-procedure pulmonary edema, the patient was electively intubated prior to the procedure. An 8fx90 cm non-medtronic sheath was advanced from the right common femoral vein to the main pa. A 7f non-medtronic coronary guide catheter was used for selective angiography and to advance a 0. 018 non-medtronic wire to the distal right pa. Systemic anticoagulation was achieved with intravenous heparin. The right pa was then studied with intravascular ultrasound imaging which confirmed severe stenosis of 96% due to fibrotic thickening of the vessel wall due primarily to thickening of the media. The pa diameter was measured at 14 mm. The stenosis was dilated using a 7 mm x 40 mm pacific plus angioplasty balloon and a 10 mm x 40 mm evercross angioplasty balloon. The result appeared sub-optimal with 60% residual stenosis and an irregular appearance to the luminal wall. Lesion length was estimated at 40 mm. The 0. 018¿ wire was exchanged for a 260 cm 0. 035¿ wire. The guide catheter and the 8fx90 cm sheath were exchanged for an 8f 45 cm sheath. An 11 mm x 59 mm non-medtronic stent was advanced to the stenosis and deployed. The stent was further dilated with a 14 mm x 60 mm non-medtronic angioplasty balloon which resulted in the expected foreshortening of the 59 mm stent to a final length of 42 mm. Final angiography revealed no residual stenosis with satisfactory stent position. As anticipated, the patient developed pulmonary edema post-procedurally which resolved in 48 h with aggressive diuresis allowing extubation. Systemic anticoagulation (for paroxysmal atrial fibrillation) was resumed with rivaroxaban 20 mg daily. Clopidogrel 75 mg daily was added and will be administered indefinitely for anti-platelet effect to minimize the risk of stent thrombosis. A repeat echocardiogram obtained 1 week after the procedure showed only minimal decrease in estimated pa pressure compared to baseline. Patient underwent a ct angiogram 3 months post-procedure which showed the pa stent to be widely patent with no evidence of restenosis and was stable without dyspnea at 6-month clinical follow-up.
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Brand NameEVERCROSS 035
Manufacturer (Section D)
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8763711
MDR Text Key150127657
Report Number2183870-2019-00360
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/05/2019 Patient Sequence Number: 1