MAUDE Adverse Event Report: THERAKOS, INC. / MALLINCKRODT HOSPITAL PRODUCTS INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Lot Number 40160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Hypoxia (1918); Thrombus (2101); Dizziness (2194)

Event Date 04/21/2020

Event Type  Injury  

Event Description

This (b)(6) year old female patient has chronic graft-versus-host disease (cgvhd) secondary to an unrelated, hla-matched bone marrow transplant (performed in (b)(6) 2014) for a diagnosis of myelofibrosis.From (b)(6) 2019, onwards, she has been treated with extracorporeal photopheresis (ecp) at a frequency of two sequential/daily procedures performed every-other-week.Her most recent ecp procedure was on (b)(6) 2020.She has a very long list of comorbidities including (but not limited to) aortic valve calcifications, chronic kidney disease, and gastrointestinal stromal tumor.Beginning on (b)(6) 2020, she began feeling increasingly dizzy.She was hospitalized on (b)(6) and noted to be mildly hypoxemic (requiring 2l o2 by nasal cannula to maintain o2 saturations greater than 94%), but with no dyspnea, respiratory complaints, or abnormalities seen on chest x-ray.On (b)(6) she developed left-sided chest pain upon inspiration.A ct angiogram revealed pulmonary embolus (pe) "in all lobes of both lungs" with a saddle thrombus observed.She was immediately started on enoxaparin (lovenox), which was switched on (b)(6) to rivaroxaban (xarelto).She thereafter recovered quickly, and on (b)(6) was transferred in stable conditions to a "step-down care" facility.In addition, we are at present preparing to discuss with this patient the possibility that her ecp treatments may have contributed (at least in part) to her pe-i.E., as has been discussed by fda in a "letter to health care providers" dated february 5, 2018.(see https://www.Fda.Gov.Medical-devices/letters-health-care-providers/death-and-pulmonaryembolism- related-extracorporeal-photopheresis-ecp-treatment-letter-health-care).Now that she is on (life-long) anticoagulation (i.E., rivaroxaban) therapy, however, we suspect her risk for recurrent pe is significantly diminished.That being said, though, the decision whether or not to continue ecp treatments (which have been very effective in controlling her cgvhd) will be hers to make once she has been suitable educated and informed of the risks versus benefits.Fda safety report id# (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC. / MALLINCKRODT HOSPITAL PRODUCTS INC.
• MDR Report Key: 10065045
• MDR Text Key: 191399981
• Report Number: MW5094524
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 40160
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Weight: 63