RESONANCE STENT SET
Report
- Report Number
- 3001845648-2022-00630
- Event Type
- Injury
- Date Received
- September 13, 2022
- Report Date
- February 24, 2025
- Manufacturer
- COOK MEDICAL IRELAND
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THE RMS DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS OPENED TO CAPTURE THE EFFECT OF URETEROILIAC ARTERY FISTULA IN THE CASE STUDY: MIYAUCHI ET AL., 2020, URETEROILIAC ARTERY FISTULA CAUSED BY FULLLENGTH METALLIC URETERAL STENTING IN A MALIGNANT URETERAL OBSTRUCTION: A CASE REPORT. LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL RMS DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, IFU0020, LIST ¿FISTULA FORMATION¿ AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE JAPANESE PACKAGING INSERT SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. PLEASE NOTE THAT THE PRECISE JAPANESE PACKAGING INSERT CANNOT BE REFERENCED AS THE RPN OF THE DEVICE IS UNKNOWN. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO INHERENT RISK OF THE DEVICE. THE INSTRUCTIONS FOR USE, IFU0020, LIST ¿FISTULA FORMATION¿ AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. OTHER FACTORS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE FORMATION OF THE FISTULA HAVE BEEN LISTED IN THE CASE STUDY MIYAUCHI ET AL. 2020. IT IS KNOWN THAT THE PATIENT HAD REPEATED PROCEDURES OF URETERAL STENTING. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO REPEATED PROCEDURES MAY HAVE CONTRIBUTED TO THE FISTULA FORMATION. AS EXPLAINED IN THE CASE STUDY, THE PRESENCE OF CHRONIC INDWELLING URETERAL CATHETERS COULD FURTHER CONTRIBUTE TO THE DEGENERATION OF THE URETERAL WALL, LEADING TO FISTULA FORMATION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. FISTULA FORMATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF THE RMS DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED SURGICAL INTERVENTION AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE RMS DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS OPENED TO CAPTURE THE EFFECT OF URETEROILIAC ARTERY FISTULA IN THE CASE STUDY: MIYAUCHI ET AL., 2020, URETEROILIAC ARTERY FISTULA CAUSED BY FULLLENGTH METALLIC URETERAL STENTING IN A MALIGNANT URETERAL OBSTRUCTION: A CASE REPORT. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL RMS DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL ((B)(4)). REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, IFU0020, LIST ¿FISTULA FORMATION¿ AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE JAPANESE PACKAGING INSERT SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. PLEASE NOTE THAT THE PRECISE JAPANESE PACKAGING INSERT CANNOT BE REFERENCED AS THE RPN OF THE DEVICE IS UNKNOWN. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO THE FOLLOWING: ¿FISTULA FORMATION¿ BEING A KNOWN POSSIBLE RISK OF DEVICE (THE INSTRUCTIONS FOR USE, IFU0020, LIST ¿FISTULA FORMATION¿ AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE.), RELATED / REPEATED PROCEDURES AND PATIENTS PRE-EXISTING CONDITION. SEVERAL FACTORS COULD HAVE RESULTED A URETEROARTERIAL FISTULA IN THIS PARTICULAR PATIENT I.E. A HISTORY OF LOCALLY ADVANCED CERVICAL CANCER WHO SUBSEQUENTLY DEVELOPED AN UPPER URETERAL OBSTRUCTION CAUSED BY RETROPERITONEAL LYMPH NODE METASTASIS, THE USE AND REPEATED EXCHANGE OF URETERAL STENTING (DOUBLE-J STENTS), HIGHER RADIATION DOSES AND A GREATER INCIDENCE OF PREVIOUS PELVIC VASCULAR AND ONCOLOGIC SURGERIES COMBINED WITH LONGER GENERAL SURVIVAL. THIS PATIENT HAD UNDERGONE 9 COURSES OF CHEMOTHERAPY, AS WELL AS WHOLE PELVIC IRRADIATION FOLLOWED BY SEVERAL OPERATIONS INCLUDING ABDOMINAL TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PARA-AORTIC AND PELVIC LYMPHADENECTOMY AND OMENTECTOMY. ALSO, THIS PATIENT DECEASED ALMOST 7 YEARS AFTER THE DIAGNOSIS OF CANCER AND LONG-TERM PLACEMENT OF METALLIC STENTS IN LONG-TERM SURVIVORS WOULD ALSO HAVE CONTRIBUTED TO THE RISK OF DEVELOPING URETEROARTERIAL FISTULA, ALL OF WHICH WOULD HAVE POSED A SIGNIFICANT RISK OF URETEROARTERIAL FISTULA TO THIS PATIENT RATHER THAN THE RMS STENT ALONE. A DEFINITIVE ROOT CAUSE OF WHETHER THE RMS STENT ITSELF COULD HAVE CONTRIBUTED TO THIS URETEROARTERIAL FISTULA COULD NOT BE DETERMINED FROM THIS PUBLICATION. HOWEVER, THIS URETEROARTERIAL FISTULA WAS LIKELY ATTRIBUTED TO THE FOREMENTIONED RISK FACTORS ABOVE AND TO THIS PATIENT'S UNDERLYING VASCULAR DISEASE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. FISTULA FORMATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF THE RMS DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED SURGICAL INTERVENTION AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
MIYAUCHI ET AL 2020 ¿ ¿URETEROILIAC ARTERY FISTULA CAUSED BY FULL LENGTH METALLIC URETERAL STENTING IN A MALIGNANT URETERAL OBSTRUCTION: A CASE REPORT.¿ CASE PRESENTATION: A DOUBLE-J POLYMERIC STENT WAS INSERTED AND EXCHANGED AT REGULAR INTERVALS EVERY 8 WEEKS FOR 1 YEAR. BECAUSE OF THE PROGRESSION OF THE DISEASE AND THE PATIENT¿S COMPLAINT OF FREQUENT STENT RE-PLACEMENT, WE REPLACED THE DOUBLE-J POLYMERIC STENT WITH A FULL-LENGTH METALLIC URETERAL STENT (RESONANCE). COMPLICATIONS: ONE YEAR AFTER THE START OF METALLIC URETERAL STENTING, WE HAD TO REPLACE THE URETERAL STENT BECAUSE OF FEBRILE URINARY TRACT INFECTION. SIX MONTHS AFTER THE SECOND METALLIC STENT PLACEMENT, THE PATIENT COMPLAINED OF GROSS HEMATURIA THAT PRESENTED BLADDER TAMPONADE. CYSTOSCOPY WAS PERFORMED BY REMOVING THE HEMATOMA, ALTHOUGH THE INSIDE OF THE BLADDER WAS INTACT. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED A HEMATOMA AT THE RIGHT URETEROPELVIC JUNCTION BUT DID NOT REVEAL THE BLEEDING SOURCE. AFTER THAT, THE PATIENT¿S INTERMITTENT MACROHEMATURIA AND MARKED ANEMIA PROGRESSED; RETROGRADE PYELOGRAPHY WAS PERFORMED FOR SUSPECTED URETEROILIAC ARTERY FISTULA. WHEN THE TIP OF THE URETERAL CATHETER WAS REMOVED FROM THE URETEROILEAL INTERSECTION, MASSIVE BLEEDING FROM THE INTERNAL OPENING OF THE URETERAL CATHETER WAS OBSERVED. WE FINALLY DIAGNOSED HER WITH URETEROILIAC ARTERY FISTULA AND IMMEDIATELY REQUESTED THE PLACEMENT OF A COVERED STENT BY ENDOVASCULAR TREATMENT DURING INTERVENTIONAL RADIOLOGY. PATIENT OUTCOME: ANGIOGRAPHY SHOWED NARROWING OF THE EXTERNAL ILIAC ARTERY BUT DID NOT DETECT A FISTULA TO THE URINARY TRACT. A HEPARIN-BONDED STENT GRAFT (GORE VIABAHN; W.L. GORE & ASSOCIATES, INC., NEWARK, DE, USA) WAS PLACED IN THE NARROWED EXTERNAL ILIAC ARTERY, FOLLOWED BY EXPANSION OF THE STENT GRAFT WITH CRIMPING. ALTHOUGH THE PATIENT¿S GROSS HEMATURIA DISAPPEARED THEREAFTER, AND NO FURTHER EPISODES OF HEMORRHAGE OCCURRED, SHE DIED 11 MONTHS LATER OF PROGRESSION OF HER PRIMARY DISEASE. THIS FILE WILL CAPTURE THE OCCURRENCE OF A URETEROILIAC ARTERY FISTULA CAUSING GROSS HEMATURIA PRESENTING AS BLADDER TAMPONADE. PATIENT OUTCOME: ANGIOGRAPHY SHOWED NARROWING OF THE EXTERNAL ILIAC ARTERY BUT DID NOT DETECT A FISTULA TO THE URINARY TRACT. A HEPARIN-BONDED STENT GRAFT (GORE VIABAHN; W.L. GORE & ASSOCIATES, INC., NEWARK, DE, USA) WAS PLACED IN THE NARROWED EXTERNAL ILIAC ARTERY, FOLLOWED BY EXPANSION OF THE STENT GRAFT WITH CRIMPING. ALTHOUGH THE PATIENT¿S GROSS HEMATURIA DISAPPEARED THEREAFTER, AND NO FURTHER EPISODES OF HEMORRHAGE OCCURRED, SHE DIED 11 MONTHS LATER OF PROGRESSION OF HER PRIMARY DISEASE.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-JAN-2023.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2534688 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK MEDICAL IRELAND | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |