RESONANCE STENT SET
Report
- Report Number
- 3001845648-2019-00096
- Event Type
- Malfunction
- Date Received
- March 11, 2019
- Report Date
- March 11, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION RMS-060012-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 RMS-060012-R OF UNKNOWN LOT NUMBER COULD NOT BE COMPLETED. THE INSTRUCTIONS FOR USE, IFU0020-15, WHICH ACCOMPANIES THIS DEVICES STATES THE INTENDED USE IS ¿ FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. INTENDED FOR ONE-TIME USE.¿ THERE IS SUFFICIENT EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU. THE PATIENT AS STATED IN THE ARTICLE HAS HAD THE STENT EXCHANGED PERIODICALLY, THE PATIENT HAS HAD 4 NO. RMS-060012-R PLACED OVER A 3 YEAR PERIOD. THIS IS LIFE-TIME STENTING; SECONDLY, RMS IS TO RESIST EXTRINSIC URETERAL OBSTRUCTION WHICH DIFFERS FROM THE OBSTRUCTION DUE TO RENAL TRANSPLANT. 5. ROOT CAUSE (POSSIBLE): THIS COMPLAINT WAS GENERATED AS THE RESULT OF AN ARTICLE WRITTEN IN THE US NATIONAL LIBRARY OF MEDICINE NATIONAL INSTITUTES OF HEALTH WITHIN THE JOURNAL OF ENDOUROLOGY CASE REPORTS AND PUBLISHED ONLINE ON (B)(6) 2017. THE DATE COOK MEDICAL IRELAND BECAME AWARE OF THIS ARTICLE WAS (B)(6) 2019. IN CASE 1 THE FEMALE PATIENT HAD THE FIRST RMS-060012-R PLACED TO MANAGE OBSTRUCTIVE UROPATHY. THE RMS-060012-R WAS SELECTED INSTEAD OF A DOUBLE PIGTAIL PLASTIC STENT, AS THE RMS-060012-R HAS A LONGER INDWELLING PERIOD OF 12 MONTHS AND WOULD GIVE A REDUCTION OF PROCEDURE TIME AND EXPOSURE TO RADIATION. THE STUDY INDICATED THE FIRST RMS-060012-R WAS PLACED AFTER THE PATIENT HAD A LIVE RELATED DONOR RENAL TRANSPLANTATION BECAUSE POSTOPERATIVELY SHE DEVELOPED OBSTRUCTIVE UROPATHY WITH MARKED HYDRONEPHROSIS. THE RMS-060012-R WAS PLACED IN THE PATIENT UNDER GENERAL ANAESTHETIC AFTER THEY HAD PREVIOUSLY PERFORMED OPEN SURGERY AND MULTIPLE DISTAL STENT MULTIPLE DISTAL STENT MIGRATION AND EXPULSIONS AND FREQUENT NEPHROSTOMY INSERTIONS. THE PLACEMENT OF THE FIRST RMS-060012-R WAS DIFFICULT DUE TO ACCESS TO THE TRANSPLANTED URETER. A NUMBER OF TECHNIQUES WERE ATTEMPTED TO PASS THE GUIDEWIRE AND INSERT THE STENT. THESE INCLUDED THE USE OF A RIGID CYSTOSCOPE, A SEMI-RIGID URETEROSCOPE, AND A FLEXIBLE CYSTOSCOPE. THE INITIAL RMS-060012-R WAS FINALLY PLACED USING A FLEXIBLE CYSTOSCOPE. THE THREE SUBSEQUENT RMS-060012-R WERE PLACED USING A FLEXIBLE CYSTOSCOPE AND EACH TIME SAW A REDUCTION IN OPERATING TIME AND RADIATION EXPOSURE TIMES. WHILE THERE IS NO PRODUCT COMPLAINT RECEIVED AND THE DEVICES HAVE FUNCTIONED WITHIN THE PATIENT WITHOUT INCIDENT, THE USE OF THE RMS-060012-R IS VIEWED AS OFF-LABEL AS RMS-060012-R ¿S INSTRUCTIONS FOR USE, IFU0020-15, STATES THAT THE DEVICE IS ¿USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. INTENDED FOR ONE-TIME USE.¿ FIRSTLY, ¿TEMPORARY¿ IS AN AMBIGUOUS TERM BECAUSE EVEN THE STENT IS ¿TEMPORARY¿ FOR 12-MONTHS, BUT FOR THE PATIENT WHO CONSTANTLY HAS HAD THE STENT EXCHANGED PERIODICALLY IS LIFE-TIME STENTING; SECONDLY, RMS-060012-R IS TO RESIST EXTRINSIC URETERAL OBSTRUCTION WHICH DIFFERS FROM THE OBSTRUCTION DUE TO RENAL TRANSPLANT. REFERENCE EMAIL FROM THE CLINICAL REVIEWER ¿PR 254940 CIRL CLINICAL INPUT CC 07MAR19¿ ATTACHED. 6. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EVENT IDENTIFIED FROM SCIENTIFIC LITERATURE: STAINER V, JONES R, AGAWAL S, SHERGILL IS (2017) THE USE OF COOK RESONANCE METALLIC URETERAL STENT IN CASES OF OBSTRUCTIVE UROPATHY FROM PERSISTENT NEOURETERAL STENOSIS, FOLLOWING KIDNEY TRANSPLANTATION, JOURNAL OF ENDOUROLOGY CASE REPORTS 3:1, 39¿41, DOI: 10.1089/CREN.2017.0005. USING RESONANCE STENT IN CASES OF OBSTRUCTIVE UROPATHY FOLLOWING KIDNEY TRANSPLANT. IS CONSIDERED OFF-LABEL AND THE RISK IS NOT REMOTE. FDA MDR REPORTING REQUIRED - THIS SPECIFIC RESONANCE DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL URETERAL STENTS/SETS (RESONANCE) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. 5-10 K NUMBER REFERENCED IS OF SIMILAR DEVICES REGISTERED IN THE US.
EVENT IDENTIFIED FROM SCIENTIFIC LITERATURE: STAINER V, JONES R, AGAWAL S, SHERGILL IS (2017). THE USE OF COOK RESONANCE METALLIC URETERAL STENT IN CASES OF OBSTRUCTIVE UROPATHY FROM PERSISTENT NEOURETERAL STENOSIS, FOLLOWING KIDNEY TRANSPLANTATION, JOURNAL OF ENDOUROLOGY CASE REPORTS 3: 1, 39¿41, DOI: 10.1089/CREN.2017.0005. USING RESONANCE STENT IN CASES OF OBSTRUCTIVE UROPATHY FOLLOWING KIDNEY TRANSPLANT. IS CONSIDERED OFF-LABEL AND THE RISK IS NOT REMOTE. FDA MDR REPORTING REQUIRED - THIS SPECIFIC RESONANCE DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL URETERAL STENTS/SETS (RESONANCE) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. 5-10 K NUMBER REFERENCED IS OF SIMILAR DEVICES REGISTERED IN THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203726 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |