MAUDE MDR 956495

MDR report key
956495
Report number
MW5004544
Event key
0
Event type
3
Date of event
2004-11-26
Date received
2007-11-28
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
1VASCULAR COIL AT ANASTOMOSIS OF COLONNONEUNKLNNYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-11-2801. D

Event Narratives#

D

Patient 1

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.