MAUDE Adverse Event Report:; EXTERNAL BEAM RADIATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Fatigue (1849); Weakness (2145); Test Result (2695)

Event Date 06/11/2016

Event Type  Injury  

Event Description

A (b)(6) female, diagnosed with progressive glioblastoma multiforme on (b)(6) 2015.She received therapy external beam radiation (2.0 gy x 27fx = 54.0gy) and bevacizumab (10 mg/kg, days 1 and 29 of radiation) on study (b)(6).The subject was assigned id/# (b)(6) and initiated therapy on (b)(6) 2016.Radiation was completed on (b)(6) 2016 and the subjects last treatment with bevacizumab prior to the event was on (b)(6) 2016.On (b)(6) 2016, the subject presented to clinic for radiation treatment complaining of increasing fatigue as well as difficulty talking and imbalance secondary to generalized weakness.The subject received daily radiation treatments and was then admitted to the hospital for observation and workup of her symptoms.Upon admission, she was found to have elevated blood troponin levels.These levels decreased, however, cardiology was consulted to rule out the possibility of myocardial infarction.A subsequent ekg ruled out mi, but given slight t wave changes, an echocardiogram was recommended.On the echocardiogram, there were changes such as mildly increased pa pressures as well as mild rv dilation noted.These findings were concerning for pulmonary embolism and thus a ct angiogram was obtained.The ct angiogram confirmed the presence of a large pulmonary embolism.The subject was then started on therapeutic enoxaparin.The pi felt the fatigue was likely related to the pulmonary embolism.On (b)(6) 2016, the subject had returned to her baseline status and was discharged home.On (b)(6) 2016, the subject returned to the er as she continued to experience dyspnea on exertion and generalized weakness since her discharge two days prior.She was admitted as an in-patient and started on oxygen, advair and prn albuterol.By (b)(6) 2016, the subject no longer required oxygen and had experienced near complete resolution of her symptoms.She was discharged to a skilled nursing facility on (b)(6) 2016.The pi felt the symptoms represented side effects of the previously diagnosed pulmonary embolism.The pi feels the pulmonary embolism is likely related to glioblastoma multiforme, unlikely related to bevacizumab, and unrelated to radiation.The pi feels the generalized weakness is possibly related to glioblastoma multiforme, unlikely related to radiation, and unrelated to bevacizumab.

• Type of Device: EXTERNAL BEAM RADIATION
• MDR Report Key: 5754581
• MDR Text Key: 48509598
• Report Number: MW5063097
• Device Sequence Number: 1
• Product Code: MUJ
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 114