MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR POLARIS URETERAL STENT; STENT, URETERAL

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

Patient Problems Bacterial Infection (1735); Fever (1858); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Hematuria (2558)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to 07/01/2019 as no event date was reported.Lot #, expiration date, manufacture date: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: study source - medical accident case collection, etc.Of the (b)(6) medical function assessment organization.(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was placed in the patient to avoid the risk of hydronephrosis and infections associated with ureteral fistula.The exact implant date was not reported.This information was obtained through inquiries from (b)(6) for medical accident information published in the medical accident case collection, etc.Of the (b)(6) medical function assessment organization.According to the literature, about five months ago, the patient had undergone radical hysterectomy and lymph node dissection for cervical cancer.The exact procedure date was not reported.About four months ago, the patient was hospitalized for suspected ureteral fistula.Exact hospitalization date was not reported.After 13 days, the polaris ultra stent was placed in the patient with no malfunctions reported.After that, the patient was in and out of the hospital in order to undergo anti-cancer drug treatments.The patient visited the local hospital for fever and hematuria this month.The patient was admitted to this hospital on the same day.Hematuria was also observed at the same time as pyelonephritis, but it was judged to be hemorrhagic cystitis on urological consultation and it was under follow-up observation.The physician planned to replace the ureteral stent after the inflammatory response improved with antibiotic treatment.Hematuria had tended to improve during antibiotic treatment, but there were multiple repeated occurrences of hematuria when the inflammatory response had been cured.The patient consulted the urology department, and hematuria also improved by bladder lavage, so it was under follow-up observation, and it was decided to perform a cystoscope stent replacement.On the 15th day of hospitalization, during retrograde ureterography from the right ureter, it was found that a contrast media was flowing from the ureter to the iliac artery.Ureteral artery fistula was suspected since it was after ureteral stent placement after surgery around the ureteral tract, and then, the diagnostic imaging department was consulted.Angiography showed that the contrast media slightly leaked from the right common iliac artery to the right ureter, so the patient was diagnosed with right ureteral common iliac artery fistula.An intravascular stent was placed at the fistula site of the right common iliac artery, expanded with a balloon, and the stent was crimped to the vascular endothelium.After that, it was confirmed by angiography that there is no leakage of contrast media from the common iliac artery, and the procedure was completed.Afterwards, the patient was discharged from the hospital.Attempts to obtain additional information regarding the circumstances surrounding the event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: study source - medical accident case collection, etc.Of the japan medical function assessment organization.Block h6: patient code 2558 captures the reportable event of hematuria.Patient code 1932 captures the reportable event of inflammation.Patient code 1858 captures the reportable event of fever.Patient code 1862 captures the reportable event of fistula.Patient code 1735 captures the reportable event of infection, bacterial.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction statement in h10: 'block h6: patient code 1735 captures the reportable event of fistula.' to 'block h6: patient code 1735 captures the reportable event of infection, bacterial.'.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was placed in the patient to avoid the risk of hydronephrosis and infections associated with ureteral fistula.The exact implant date was not reported.This information was obtained through inquiries from pharmaceuticals and medical devices agency (pmda) for medical accident information published in the medical accident case collection, etc.Of the japan medical function assessment organization.According to the literature, about five months ago, the patient had undergone radical hysterectomy and lymph node dissection for cervical cancer.The exact procedure date was not reported.About four months ago, the patient was hospitalized for suspected ureteral fistula.Exact hospitalization date was not reported.After 13 days, the polaris ultra stent was placed in the patient with no malfunctions reported.After that, the patient was in and out of the hospital in order to undergo anti-cancer drug treatments.The patient visited the local hospital for fever and hematuria this month.The patient was admitted to this hospital on the same day.Hematuria was also observed at the same time as pyelonephritis, but it was judged to be hemorrhagic cystitis on urological consultation and it was under follow-up observation.The physician planned to replace the ureteral stent after the inflammatory response improved with antibiotic treatment.Hematuria had tended to improve during antibiotic treatment, but there were multiple repeated occurrences of hematuria when the inflammatory response had been cured.The patient consulted the urology department, and hematuria also improved by bladder lavage, so it was under follow-up observation, and it was decided to perform a cystoscope stent replacement.On the 15th day of hospitalization, during retrograde ureterography from the right ureter, it was found that a contrast media was flowing from the ureter to the iliac artery.Ureteral artery fistula was suspected since it was after ureteral stent placement after surgery around the ureteral tract, and then, the diagnostic imaging department was consulted.Angiography showed that the contrast media slightly leaked from the right common iliac artery to the right ureter, so the patient was diagnosed with right ureteral common iliac artery fistula.An intravascular stent was placed at the fistula site of the right common iliac artery, expanded with a balloon, and the stent was crimped to the vascular endothelium.After that, it was confirmed by angiography that there is no leakage of contrast media from the common iliac artery, and the procedure was completed.Afterwards, the patient was discharged from the hospital.Attempts to obtain additional information regarding the circumstances surrounding the event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: CONTOUR POLARIS URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8879560
• MDR Text Key: 154029143
• Report Number: 3005099803-2019-04002
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR