MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

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

Patient Problems Pain (1994); Renal Failure (2041)

Event Date 01/09/2007

Event Type  Injury  

Event Description

It was reported via journal article that a patient developed anuria immediately after embolization.The patient was admitted to the hospital because of right flank pain and gross hematuria.Physical examination revealed tenderness of the right upper quadrant.The complete blood count, electrolytes and serum calcium were normal.Blood urea nitrogen (bun) was 18 mg/dl and serum creatinine (cr) was 1.2 mg/dl.Macroscopic and microscopic examinations of the urine showed hematuria.Ultrasonographic examination revealed a large heterogeneous hypoechoic mass lesion measuring 5 cm x 4 cm x 4 cm, involving the upper half of the right kidney.Subsequently abdominal computed tomography confirmed the sonographic findings, showing a contrast-enhanced tumoral mass lesion which was suggestive of primary right renal tumor with invasion of the perinephric fat.An ultrasound-guided biopsy was performed.Histopathologic examination of the tumor revealed renal cell carcinoma.Because of the patient's unwillingness to undergo radical surgery, percutaneous transarterial embolization (tae) was scheduled for the purpose of reduction of the mass, and to control the gross hematuria and persistent flank pain.The patient was hydrated with 1 liter of saline within 6 hr before the embolization.Abdominal aortography showed the tumor was feeding only from the right renal artery.There was no parasitic feeding artery.After the right renal artery had been catheterized selectively with a renal catheter, the hypervascular tumor was located and total embolization of the kidney was approved.Under fluoroscopic control, renal artery embolization was performed using two vials of contour polyvinyl alcohol particles (355-500 lm) until complete flow stagnation was achieved in the branches of renal artery.During the embolization procedure 100 ml of ultravist 370 mg i/ml was used.After the procedure the patient complained of increased right flank pain and anuria while in the intensive care unit.The patient was apyrexic and treated with tramadol for pain.Bladder catheterization showed that no urine was present in the bladder, and serum cr was 5.4 mg/dl and bun 38 mg/dl at the 12th postprocedural hour.Renal ultrasonography was performed which ruled out an obstructive cause of anuria.A plain film of the abdomen showed no radiopaque stone in the area of the urinary system.The patient was treated with 3 liters of saline followed by furosemide 100 mg intravenously.The patient remained anuric and the serum cr and bun continued to increase (cr 8.5 mg/dl and bun 42 mg/dl at the 54th postprocedural hour).Peritoneal dialysis was planned, but the patient experienced good diuresis (over 3 liters within the first 24 hr) at the 74th hour.Serum cr was 7.7 mg/dl and bun 41 mg/dl at the 80th hour.The patient's cr continued to fall.On the day of discharge, 8 days after embolization, cr was 2.0 mg/dl and bun 22 mg/dl.The patient was followed closely as an outpatient and on postembolization day 56, the patient's cr was 1.4 mg/dl and bun 21 mg/dl.

Manufacturer Narrative

Date of event estimated using date article was published.Initial reporter facility name: (b)(6).Kervancioglu, s., sirikci, a.& erbagci, a.Reflex anuria after renal tumor embolization.Cardiovasc intervent radiol 30, 304-306 (2007).Https://doi.Org/10.1007/s00270-005-0383-7.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15083866
• MDR Text Key: 296379732
• Report Number: 2134265-2022-08047
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female