FDA.reportPublic FDA data

MAUDE MDR 4538362

MDR report key
4538362
Report number
MW5040803
Event key
0
Event type
3
Date of event
2014-12-19
Date received
2015-02-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SBRTSBRTIXQ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-1301. D

Event Narratives#

D

Patient 1

PATIENT WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2013. THE PATIENT RECEIVED SBRT ON (B)(6) 2013 FOR A TOTAL OF 2400CGY. THE PATIENT HAD BEEN IN FOLLOW-UP WITHOUT RECURRENCE OF DISEASE AS OF LAST SCAN DONE IN (B)(6) 2014. PER FAMILY, PATIENT DEVELOPED COUGHING WITH SEVERE HEMOPTYSIS, PATIENT ARRIVED VIA EMS AT OUTSIDE MEDICAL CENTER IN CARDIAC ARREST AND EXPIRED IN THE ED ON (B)(6) 2014. THE PI HAS DETERMINED THAT THE EVENT IS A RARE OCCURRENCE AND LATE TOXICITY, LIKELY RELATED TO SBRT WHERE THE LARGE BLOOD VESSELS AROUND THE HEART MAY HAVE HEMORRHAGED. THE CTCAE 4.03 GRADABLE EVENT OF BRONCHOPULMONARY HEMORRHAGE GRADE 5 IS BEING REPORTED AND IS LIKELY RELATED TO SBRT. CARDIAC ARREST IS SECONDARY TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AND AUTOPSY WAS NOT PERFORMED PER FAMILY WISHES. DIAGNOSIS FOR USE: ADENOCARCINOMA LUNG, SBRT.