CELLEX SYSTEM
Received Mar 10, 2020 · Event occurred Jun 21, 2019
Report MW5093661 · MDR key 9818142
Device
Generic name
System, Photopheresis, Extracoporeal
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR
- Pulmonary Embolism
- Pulmonary Embolism
Narrative
Description of Event or Problem
PULMONARY EMBOLI (PE) WAS DIAGNOSED IN A PT WHO HAD RECEIVED 18 EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENTS VIA THE CELLEX SYSTEM. BRONCHIOLITIS OBLITERANS SYNDROME (BOS). THE PT RECEIVED IS 18TH ECP TREATMENT ON (B)(6) 2019. THE PE EVENT OCCURRED ON (B)(6) 2019. THE PI REPORTED NO RELATIONSHIP. THE PT WAS HOSPITALIZED FOR THE EVENT. THE PT WAS INITIALLY EVALUATED IN CLINIC FOR INCREASED SHORTNESS OF BREATH AND ADMITTED TO THE HOSP. CT CHEST WITHOUT CONTRAST (B)(6) 2019: POSTOPERATIVE CHANGE FROM BILATERAL LUNG TRANSPLANT, ECCENTRIC NONOCCLUSIVE FILLING DEFECT WITHIN THE RIGHT MAIN PULMONARY ARTERY PROXIMAL TO THE PULMONARY ARTERY ANASTOMOSIS MEASURING 2.9 X 1.6 CM. FINDINGS ARE CONSISTENT WITH THROMBUS; HOWEVER, THE CHRONICITY IS UNCERTAIN AND COULD BE ACUTE OR CHRONIC; NEW BILATERAL GROUNDGLASS AND PATCHY CONSOLIDATIVE OPACITIES MOST SEVERELY AFFECTING THE LEFT UPPER LOBE. FINDINGS FAVOR MULTIFOCAL INFECTION; DIFFUSE MOSAIC ATTENUATION OF THE LUNGS MOST COMMONLY ASSOCIATED WITH AIR TRAPPING / CONSTRICTIVE BRONCHIOLITIS; NEW 4MM RIGHT UPPER LOBE NODULE MAY BE INFLAMMATORY, HOWEVER RECOMMEND 3 MONTH F/U TO ENSURE STABILITY; AORTIC AND CORONARY ARTERY ATHEROSCLEROSIS. STABLE MILD DILATION OF THE MID ASCENDING AORTA MEASURING 4 CM. THE MAIN PULMONARY ARTERY IS DILATED; PNEUMOBILIA WHICH IS NEW FROM THE PRIOR CORRELATE WITH INTERVAL INTERVENTIONS. TREATED WITH HEPARIN DRIP AND CHANGED TO ORAL ANTICOAGULATION. THE PT RECEIVED 18 ECP TREATMENTS FOR BRONCHIOLITIS OBITERONS SYNDROME: (B)(6) 2019, (B)(6) 2019, (B)(6) 2019, (B)(6) 2019. FOLLOWING THE PE EVENT THE PT RESUMED ECP TREATMENTS AND COMPLETED 24 TOTAL.