RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
Report
- Report Number
- 3001845648-2020-00591
- Event Type
- Injury
- Date Received
- September 9, 2020
- Date of Event
- June 13, 2019
- Report Date
- November 2, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
INFORMATION PERTAINING TO SECTION F. 3 AS FOLLOWS: (B)(6) INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THE UNKNOWN RMS DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE "NAVETTA - TANDEM RESONANCE METALLIC DOUBLE J URETERAL STENTS - REVIEWED VERSION.PDF" COMPLAINT FILES PR 308244 (REF MDR# 3001845648-2020-00589), (B)(4) (REF MDR# 3001845648-2020-00590), (B)(4) (REF MDR# 3001845648-2020-00591), (B)(4) (REF MDR# 3001845648-2020-00593) & (B)(4) (REF MDR# 3001845648-2020-00592) WERE OPENED AS A RESULT OF THIS PAPER. WITHIN THE PAPER IN "TABLE 1 -CHARACTERISTICS OF FOUR PATIENTS WHO RECEIVED TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION", DESCRIBED THE ADVERSE EFFECTS EXPERIENCED BY THE 4 PATIENTS DISCUSSED IN THE PAPER. COMPLIANT FILE MDR# 3001845648-2020-00589 RELATES TO ALL 4 PATIENTS IN STUDY HAD A SINGLE RMS FAIL PRIOR TO THE STUDY. COMPLIANT FILE MDR# 3001845648-2020-00590 RELATES TO PATIENT # 2 WHERE TANDEM RESONANCE STENTS (TRS) FAILED DUE TO HYDRONEPHROSIS AND RENAL FAILURE WHICH WAS MANAGED WITH A NEPHROSTOMY. ALSO CAPTURED IN THIS FILE, IS THE USER ERROR OF THE INCORRECT WIRE GUIDE USED TO PLACE THE FOUR STENTS. COMPLIANT FILE MDR# 3001845648-2020-00591 RELATES TO PATIENT # 4 WHERE TRS FAILED DUE TO FLANK PAIN AND RENAL FAILURE AND WAS MANAGED BY A NEPHROSTOMY . ALSO CAPTURED IN THIS FILE, IS THE USER ERROR OF THE INCORRECT WIRE GUIDE USED TO PLACE THE TWO STENTS. COMPLIANT FILE MDR# 3001845648-2020-00593 RELATES TO THE USER ERROR OF INCORRECT WIRE GUIDE SIZE USED IN PLACING ALL 14 STENTS IN THE 4 PATIENTS. A 0.035 HYDROPHILIC GUIDEWIRE WAS USED. RECOMMENDED TO USE WITH WIRE GUIDE 0.038¿ DIAMETER. THIS FILE (B)(4) IS TO BE CANCELLED AS THE USER ERROR OF THE INCORRECT WIRE GUIDE WILL BE DISCUSSED WITHIN THE EXISTING FILES (B)(4) (REF MDR# 3001845648-2020-00590),(B)(4) (REF MDR# 3001845648-2020-00591) &(B)(4) (REF MDR# 3001845648-2020-00592) COMPLAINT FILE MDR# 3001845648-2020-00592 RELATES TO OVERALL OFF LABEL OF THE PLACEMENT OF TANDEM RESONANCE STENTS (TRS). A DEVICE WAS ALSO USED ON ONE PATIENT WITH DYSTROPHIC CALCIFICATIONS TREATED (NOT EXTRINSIC COMPRESSION), ALSO OFF-LABEL USE. THE FILE PR 308255 CAPTURES THE OFF LABEL USE OF 8 OF THE STENTS OF WHICH 14 IN TOTAL WHERE USED OFF LABEL. ALSO CAPTURED IN THIS FILE, IS THE USER ERROR OF THE INCORRECT WIRE GUIDE USED TO PLACE THE EIGHT STENTS. THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN SEVEN RENAL UNITS THAT EQUATES TO A TOTAL OF 14 RMS STENTS BEING PLACED OFF LABEL. HOWEVER AS 6 /14 CASES OF OFF LABEL USE ARE ALREADY CAPTURED IN MDR# 3001845648-2020-00590( 4/14) AND MDR# 3001845648-2020-00591 (2/14), THE FILE MDR# 3001845648-2020-00592 CAPTURES THE REMAINING 8 CASES OF OFF LABEL USE. AS PER THE MEDICAL ADVISOR - THE SIMULTANEOUSLY PLACING TWO RMS STENTS IN TANDEM (SIDE-BY-SIDE) IN ONE URETER HAS BEEN ADVISED AS OFF-LABEL USE DESPITE THERE BEING NO SPECIFIC CONTRAINDICATIONS TO THIS IN THE IFU AND ALSO THERE IS NO GUIDANCE FOR PLACING STENTS IN TANDEM . SEE EMAIL ATTACH "RE: OFF-LABEL USE" LAB EVALUATION ¿ N/A IMAGE REVIEW ¿ N/A DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION RMS-060026-R DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL A REVIEW OF THE MANUFACTURING RECORDS FOR THE UNKNOWN RMS DEVICE COULD NOT BE COMPLETED AS THE LOT NUMBER WAS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0020-17) STATES THE FOLLOWING: INTENDED USE " USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. INTENDED FOR ONE-TIME USE" ¿WARNINGS ¿THESE STENTS ARE NOT INTENDED AS PERMANENT INDWELLING DEVICES. ¿THE STENT MUST NOT REMAIN INDWELLING MORE THAN TWELVE (12) MONTHS. IF THE PATIENT¿S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT. ¿ PATIENTS SHOULD BE CHECKED AT REGULAR INTERVAL UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENT USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE¿ IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0020-17, THE USER IS INSTRUCTED THAT ¿HEMATURIA AND INCONTINENCE MAY INDICATE FISTULA FORMATION.¿ PER THE INSTRUCTIONS FOR USE (IFU0020-17) STATES THE FOLLOWING POTENTIAL EVENTS: LOSS OF RENAL FUNCTION, PAIN/DISCOMFORT, HYDRONEPHROSIS" IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0020-17). AS PER THE MEDICAL ADVISOR - THE SIMULTANEOUSLY PLACING TWO RMS STENTS IN TANDEM (SIDE-BY-SIDE) IN ONE URETER HAS BEEN ADVISED AS OFF-LABEL USE DESPITE THERE BEING NO SPECIFIC CONTRAINDICATIONS TO THIS IN THE IFU AND ALSO THERE IS NO GUIDANCE FOR PLACING STENTS IN TANDEM . PER THE INSTRUCTIONS FOR USE (IFU0020-17) STATES "RECOMMENDED WIRE GUIDE TO USE WITH WIRE GUIDE 0.038¿ DIAMETER". AS PER LITERATURE PAPER; ''SEVEN RENAL UNITS FROM FOUR PATIENTS WITH A MEDIAN AGE OF 62 YEARS WERE MANAGED WITH TRS.' AND 'CYSTOSCOPICALLY, A 0.035 HYDROPHILIC GUIDEWIRE IS USED TO CANNULATE THE AFFECTED URETERAL ORIFICE AND IS ADVANCED INTO THE RENAL PELVIS UNDER FLUOROSCOPIC GUIDANCE'' THIS USE ERROR IN THE CASE OF THE WIRE GUIDE. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE MEDICAL ADVISOR ALSO CONFIRMED THE FLANK PAIN WAS CAUSED BY HYDRONEPHROSIS CAUSED BY STENT OBSTRUCTION OR THE RETROPERITONEAL FIBROSIS ITSELF. BOTH COULD HAVE CAUSED RENAL FAILURE. THE FLANK PAIN IS A SYMPTOM NOT THE CAUSE OF RENAL FAILURE. FURTHER TO THE OFF LABEL USE OF THE RMS STENTS, IT WAS NOTED THE INCORRECT SIZED WIRE GUIDE WAS USED TO PLACE THE RMS STENTS. THIS FILE COVERS 2 DEVICES AND THEREFORE 2 INCORRECT WIRE GUIDES WERE USED IN ERROR TOO. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT # 4 REQUIRED NEPHROSTOMY. MEDICAL ADVISOR HAS CONFIRMED THAT DEATH IS LIKELY RELATED TO DISEASE / PALLIATION AND NOT CAUSED / CONTRIBUTED BY DEVICE.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED AS FURTHER TO THE OFF LABEL USE OF THE RMS STENTS, IT WAS NOTED THE INCORRECT SIZED WIRE GUIDE WAS USED TO PLACE THE RMS STENTS. THIS FILE COVERS 2 DEVICES AND THEREFORE 2 INCORRECT WIRE GUIDES WERE USED IN ERROR ALSO. RELATED TO REPORTS# 3001845648-2020-00590 AND 3001845648-2020-00592. INITIAL REPORT DETAILS: "NAVETTA, 2019 ¿TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION¿ AS PER TABLE 1 - PATIENT # 4 TRS FAILED DUE TO FLANK PAIN AND RENAL FAILURE AND WAS MANAGED BY A NEPHROSTOMY. AS PER LITERATURE PAPER; ''IN OUR STUDY, ONLY ONE PATIENT WITH METASTATIC COLON CANCER WAS NEVER SUCCESSFULLY MANAGED WITH TRS. A PCN WAS REPLACED AFTER JUST 6 DAYS FOR FLANK PAIN, AND HE DIED 82 DAYS LATER.'' MEDICAL ADVISOR HAS CONFIRMED THAT DEATH IS LIKELY RELATED TO DISEASE / PALLIATION AND NOT CAUSED / CONTRIBUTED BY DEVICE' PLEASE NOTE: THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN 1 RENAL UNITS FOR PATIENT #4 THAT EQUATES TO A TOTAL OF 2 RMS STENTS BEING PLACED. PLEASE ALSO NOTE, ALTHOUGH WE CANNOT CONFIRM THE EXACT RPN OF THE RESONANCE METALLIC DOUBLE-J URETERAL STENTS USED IT HAD THE POTENTIAL TO BE ANY ONE OF THE FOLLOWING: (B)(4) THIS FILE IS CREATED TO CAPTURE PATIENT 4 FLANK PAIN AND RENAL FAILURE REQUIRING NEPHROSTOMY.
INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
(B)(6). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
"NAVETTA, 2019 ¿TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION¿. AS PER TABLE 1 - PATIENT # 4 TRS FAILED DUE TO FLANK PAIN AND RENAL FAILURE AND WAS MANAGED BY A NEPHROSTOMY. AS PER LITERATURE PAPER; ''IN OUR STUDY, ONLY ONE PATIENT WITH METASTATIC COLON CANCER WAS NEVER SUCCESSFULLY MANAGED WITH TRS. A PCN WAS REPLACED AFTER JUST 6 DAYS FOR FLANK PAIN, AND HE DIED 82 DAYS LATER.'' MEDICAL ADVISOR HAS CONFIRMED THAT DEATH IS LIKELY RELATED TO DISEASE / PALLIATION AND NOT CAUSED / CONTRIBUTED BY DEVICE'. PLEASE NOTE: THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN 1 RENAL UNITS FOR PATIENT #4 THAT EQUATES TO A TOTAL OF 2 RMS STENTS BEING PLACED. PLEASE ALSO NOTE, ALTHOUGH WE CANNOT CONFIRM THE EXACT RPN OF THE RESONANCE METALLIC DOUBLE-J URETERAL STENTS USED IT HAD THE POTENTIAL TO BE ANY ONE OF THE FOLLOWING: RMS-060012-R, RMS-060014-R, RMS-060016-R, RMS-060018-R, RMS-060020-R, RMS-060022-R, RMS-060024-R, RMS-060026-R, RMS-060028-R, RMS-060030-R. THIS FILE IS CREATED TO CAPTURE PATIENT 4 FLANK PAIN AND RENAL FAILURE REQUIRING NEPHROSTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 976488 | RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |