VASCULAR COIL AT ANASTOMOSIS OF COLON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-28 for VASCULAR COIL AT ANASTOMOSIS OF COLON manufactured by Unk.

Event Text Entries

[782872] A g l was admitted for gi bleeding from rectum. Two colonoscopies done not revealing bleeding site. Angiogram done, first one not revealing bleeding site, so they gave him tpa to 'make him bleed at angio', still didn't reveal a bleeding site. They sent him back to the floor after the test, he bled out 2 liters during the night and went to icu. Stabilized in icu and returned to the floor later that day. Physicians did second angio of gut looking for bleed source, stated they put in 'coils in the area of the anastamosis from 2001 hemicolectomy site. Patient developed r sided focused abd pain where coil would have been; family and pt pointed this out at 3pm and throughout the evening. Medical staff stated this was normal pain, and provided him with morphine. Patient was to be dismissed to home with wife and babies the next day. Family received a call at 9am requesting permission for emergency surgery as pt may not survive. They removed a significant portion of bowel in area where coils were placed. He had an open midline incision not closed postop with two new colostomies. Medical team/hospital states this was a mystery and will not explain what happened to family. They will not share reason, he had colon removed, colostomies, etc. Our intent is we don't want this to happened to any other pt. He died directly after 1 day in icu. Did the coils shut off his blood supply at area of old anastomosis leading to ischemic bowel and death? If so, is there a way to prevent this from occurring to other pts. Also, is it normal practice to give tpa during mesenteric angio to an end stage renal disease bleeding pt as this caused him to lose significant blood after first mes angiogram.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5004544
MDR Report Key956495
Date Received2007-11-28
Date of Report2007-11-28
Date of Event2004-11-26
Date Added to Maude2007-12-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVASCULAR COIL AT ANASTOMOSIS OF COLON
Generic NameNONE
Product CodeLNN
Date Received2007-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagY
Date RemovedB
Device Sequence No1
Device Event Key929775
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2007-11-28

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