RESONANCE STENT SET
Report
- Report Number
- 3001845648-2018-00539
- Event Type
- Injury
- Date Received
- November 22, 2018
- Date of Event
- October 25, 2018
- Report Date
- February 21, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- UDI-DI
- 10827002341095
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER: K063742. 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.
510 (K) NUMBER: K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1. DEVICE EVALUATION: 1 X RMS-060022-R OF LOT NUMBER C1296687 WAS RETURNED TO CIRL FOR AN EVALUATION. IT WAS RETURNED USED AND BROKEN AND IT WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. 2. LAB EVALUATION: 1 X RMS-060022-R OF LOT NUMBER C1296687 WAS RETURNED TO CIRL FOR AN EVALUATION AFTER SOME TIME AFTER THE ORIGINAL INVESTIGATION WAS CONCLUDED. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN LABORATORY ON (B)(6) 2019. THE RETURNED DEVICE LAB EXAMINATION FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH ATTACHED PHOTOS. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION. A BROKEN PART OF THE STENT, IT WAS APPROX. 5CM IN LENGTH WAS RETURNED THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THROUGH PREVIOUSLY SUBMITTED THE IMAGES. 3. IMAGE REVIEW: AN IMAGE REVIEW WAS COMPLETED ON (B)(6) SEE ATTACHED ¿(B)(4) IMAGING REVIEW VER1.PDF¿. THE SUMMARY FROM THE IMAGE REVIEW IS A FRACTURE OF A RESONANCE METALLIC URETERAL STENT DURING ATTEMPTED EXCHANGE AFTER A DWELL TIME EXCEEDING THE IFU RECOMMENDED DWELL TIME. THE RIGHT STENT FRACTURED NEAR THE RENAL PELVIS WHEN RESISTANCE WAS FELT BY THE PHYSICIAN. THE DISTAL COMPONENT REMAINED INSIDE THE PATIENT, GIVEN THE POINT OF FRACTURE, THIS LIKELY INDICATES THERE WAS EITHER STENT ENCRUSTATION OR TISSUE INGROWTH INVOLVING THE RENAL PORTION OF THE STENT, INHIBITING ITS REMOVAL. THERE WAS NO DISCUSSION IN THE COMPLAINT REPORT REGARDING ANY CLINICAL SCENARIOS THAT MAY HAVE FACILITATED EITHER THESE 2 SCENARIOS AND IS THEREFORE LIKELY RELATED TO THE PROLONGED DWELL TIME. 4. ROOT CAUSE (POSSIBLE): A POSSIBLE CAUSE OF THIS COMPLAINT COULD BE ATTRIBUTED TO THE DWELL TIME WHICH EXCEEDED THE RECOMMENDED DWELL TIME OF 12 MONTHS AND IT IS POSSIBLE THERE WAS EITHER STENT ENCRUSTATION OR TISSUE INGROWTH INVOLVING THE RENAL PORTION OF THE STENT, INHIBITING ITS REMOVAL AS A RESULT OF THIS EXTENDED DWELL TIME. 5. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR RMS-060022-R OF LOT # C1296687 DID NOT REVEAL ANY ISSUES ASSOCIATED WITH THIS COMPLAINT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1296687; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1296687. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL STEP 1.1 ¿CHECK FOR KINKS OR DAMAGE ALONG STENT LENGTH,¿ STEP 1.4 ¿ENSURE SMOOTH AND CLEAN (NON- DISCOLORED) WELDED ENDS¿ AND STEP 1.5 ¿TUG AT BOTH ENDS OF THE STENT TO CONFIRM THE INNER WIRE TO COILED WIRE CONNECTION.¿ THE INSTRUCTIONS FOR USE, IFU0020-15 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER ¿ 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.¿ ALSO IT WARNS ¿INDIVIDUAL VARIATIONS OF INTERACTIONS BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS 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.¿ ALSO THE INSTRUCTION FOR USE WARNS THE USER ¿IF ANY RESISTANCE IS ENCOUNTERED WHEN REMOVING THE URETERAL STENT, DETERMINE THE CAUSE OF THE RESISTANCE BY SUCH AS X-RAY EXAMINATION AND PERFORM APPROPRIATE TREATMENT. FORCEFUL REMOVAL MAY RESULT IN DAMAGE TO RENAL PELVIS AND THE URETER.¿ THE STENTS WERE PLACED IN (B)(6) 2017 AND REMOVAL WAS (B)(6) 2018, WHICH EXCEEDS THE INDWELL TIME AS OUTLINED IN THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE. THE USER DID NOT FOLLOW THE INSTRUCTION FOR USE FOR THIS DEVICE. 6. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE PATIENT DIDN¿T EXPERIENCE ANY ADVERSE AS RESULT OF THE DEVICE FAILURE AND BASED ON THE INFORMATION PROVIDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510 (K) NUMBER: K063742. 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. THE DEVICE WAS RETURNED PENDING EVALUATION, AN ADDITIONAL MDR WILL BE SUBMITTED TO INCLUDE THE EVALUATION FINDINGS.
510 (K) NUMBER: K063742. 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. 1 X RMS-060022-R OF LOT NUMBER C1296687 WAS NOT RETURNED TO CIRL FOR AN EVALUATION THEREFORE A LIMITED DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. AN IMAGE REVIEW WAS COMPLETED ON 20TH OF NOVEMBER, THE SUMMARY FROM THE IMAGE REVIEW IS A FRACTURE OF A RESONANCE METALLIC URETERAL STENT DURING ATTEMPTED EXCHANGE AFTER A DWELL TIME EXCEEDING THE IFU RECOMMENDED DWELL TIME. THE RIGHT STENT FRACTURED NEAR THE RENAL PELVIS WHEN RESISTANCE WAS FELT BY THE PHYSICIAN. THE DISTAL COMPONENT REMAINED INSIDE THE PATIENT, GIVEN THE POINT OF FRACTURE, THIS LIKELY INDICATES THERE WAS EITHER STENT ENCRUSTATION OR TISSUE INGROWTH INVOLVING THE RENAL PORTION OF THE STENT, INHIBITING ITS REMOVAL. THERE WAS NO DISCUSSION IN THE COMPLAINT REPORT REGARDING ANY CLINICAL SCENARIOS THAT MAY HAVE FACILITATED EITHER THESE 2 SCENARIOS AND IS THEREFORE LIKELY RELATED TO THE PROLONGED DWELL TIME. A POSSIBLE CAUSE OF THIS COMPLAINT COULD BE ATTRIBUTED TO THE DWELL TIME WHICH EXCEEDED THE RECOMMENDED DWELL TIME OF 12 MONTHS AND IT IS POSSIBLE THERE WAS EITHER STENT ENCRUSTATION OR TISSUE INGROWTH INVOLVING THE RENAL PORTION OF THE STENT, INHIBITING ITS REMOVAL AS A RESULT OF THIS EXTENDED DWELL TIME. HOWEVER, AS THE DEVICE WAS NOT RETURNED AND THE CLINICAL CONDITIONS CANNOT BE REPLICATED IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. A REVIEW OF THE MANUFACTURING RECORDS FOR RMS-060022-R OF LOT # C1296687 DID NOT REVEAL ANY ISSUES ASSOCIATED WITH THIS COMPLAINT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1296687; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1296687. THE INSTRUCTIONS FOR USE, IFU0020-15 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER ¿ THE STENT MUST NOT REMAIN INDWELLING MORE THAN TWELVE MONTHS. IF THE PATIENT¿S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT.¿ ALSO IT WARNS ¿INDIVIDUAL VARIATIONS OF INTERACTIONS BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS 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.¿ ALSO THE INSTRUCTION FOR USE WARNS THE USER ¿IF ANY RESISTANCE IS ENCOUNTERED WHEN REMOVING THE URETERAL STENT, DETERMINE THE CAUSE OF THE RESISTANCE BY SUCH AS X-RAY EXAMINATION AND PERFORM APPROPRIATE TREATMENT. FORCEFUL REMOVAL MAY RESULT IN DAMAGE TO RENAL PELVIS AND THE URETER.¿ THE STENTS WERE PLACED IN (B)(6) 2017 AND REMOVAL WAS (B)(6) 2018, WHICH EXCEEDS THE INDWELL TIME AS OUTLINED IN THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE. THE USER DID NOT FOLLOW THE INSTRUCTION FOR USE FOR THIS DEVICE. A NOTIFICATION OF USER ERROR HAS BEEN SEND TO THE PRODUCT MANAGER SEE ATTACHED EMAIL CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. THE PATIENT DIDN¿T EXPERIENCE ANY ADVERSE AS RESULT OF THE DEVICE FAILURE AND BASED ON THE INFORMATION PROVIDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES AFTER 12 MONTHS OF PLACEMENT. ONE STENT COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE PATIENT. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED ON (B)(6) 2018, ON (B)(6) 2017 (EXACT DATE UNKNOWN): RMS-060022-R/ LOT# C1296687 (COMPLAINT DEVICE) AND RMS-060022-R/ LOT# C1307377 WERE PLACED IN THE RIGHT AND LEFT SIDES RESPECTIVELY. THERE HAD BEEN NO PROBLEM OBSERVED IN THE RENAL FUNCTION AND DEVICES PERFORMANCE OF DRAINAGE DURING PLACEMENT. ON (B)(6) 2018: RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES. ONE STENT (C1307377) COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT (C1296687) AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE RENAL PELVIS. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. AS OF (B)(6) 2018: THE PATIENT HAD A FAVORABLE OUTCOME WITHOUT BLEEDING AFTER STENTS EXCHANGE. THE PHYSICIAN HAS A PLAN TO RETRIEVE THE REMAINED SEGMENT FROM THE RENAL PELVIS PERCUTANEOUSLY THROUGH THE NEPHROSTOMY ROUTE SINCE THE PRE EXISTING DISEASE IS RETROPERITONEAL FIBROSIS WHICH IS BENIGN AND GOOD PROGNOSIS CAN BE EXPECTED. HOWEVER, THE PATIENT DOES NOT PARTICULARLY REQUIRE EXTRACTION OF THE REMAINED SEGMENT SINCE NO PROBLEM HAS OCCURRED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES AFTER 12 MONTHS OF PLACEMENT. ONE STENT COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE PATIENT. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. <UPDATED (B)(6) 2018, (B)(6) 2017 (EXACT DATE UNKNOWN): RMS-060022-R/ LOT# C1296687 (COMPLAINT DEVICE) AND RMS-060022-R/ LOT# C1307377 WERE PLACED IN THE RIGHT AND LEFT SIDES RESPECTIVELY. THERE HAD BEEN NO PROBLEM OBSERVED IN THE RENAL FUNCTION AND DEVICES PERFORMANCE OF DRAINAGE DURING PLACEMENT. (B)(6) 2018: RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES. ONE STENT (C1307377) COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT (C1296687) AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE RENAL PELVIS. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. AS OF (B)(6) 2018: THE PATIENT HAD A FAVORABLE OUTCOME WITHOUT BLEEDING AFTER STENTS EXCHANGE. THE PHYSICIAN HAS A PLAN TO RETRIEVE THE REMAINED SEGMENT FROM THE RENAL PELVIS PERCUTANEOUSLY THROUGH THE NEPHROSTOMY ROUTE SINCE THE PRE EXISTING DISEASE IS RETROPERITONEAL FIBROSIS WHICH IS BENIGN AND GOOD PROGNOSIS CAN BE EXPECTED. HOWEVER, THE PATIENT DOES NOT PARTICULARLY REQUIRE EXTRACTION OF THE REMAINED SEGMENT SINCE NO PROBLEM HAS OCCURRED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. <ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2018, (B)(4)> IT WAS CONFIRMED WITH THE PHYSICIAN THAT THE REMAINED SEGMENT WOULD BE RETRIEVED FROM THE PATIENT VIA THE PERCUTANEOUS APPROACH ON (B)(6) 2019. THE SEGMENT WILL BE RETURNED TO COOK FOR INVESTIGATION. <ADDITIONAL INFORMATION ((B)(6) 2019, (B)(4))> (B)(6) 2019: THE RMS- STENT WHICH HAD BEEN PLACED ON (B)(6) 2018 AFTER THE REPORTED EVENT WAS REMOVED TRANSURETHRALLY WITH NO PROBLEM. (B)(6) 2019: THE PHYSICIAN PERFORMED RETRIEVAL OF THE REMAINED SEGMENT AS PLANNED. THE PATIENT CONDITIONS INCLUDING RENAL FUNCTION HAD BEEN EXCELLENT. A NEPHROSTOMY TRACT WAS ESTABLISHED WITH AN ULTRAXX NEPHROSTOMY BALLOON PERCUTANEOUSLY. THOUGH THE TIP OF THE REMAINED SEGMENT LOOKED AS IF IT HAD BEEN EMBEDDED IN THE DISTAL RENAL CALIX UNDER FLUOROSCOPIC GUIDANCE PRIOR TO ESTABLISHING THE NEPHROSTOMY TRACT, PYELOSCOPE SHOWED THE SEGMENT RIGHT IN FRONT, WHICH MADE THE PHYSICIAN IMPOSSIBLE TO OBSERVE HOW THE TIP HAD BEEN POSITIONED. THE SEGMENT WAS RETRIEVED WITH FORCEPS SUCCESSFULLY AND FOUND TO BE SO CLEAN AS IT LOOKED LIKE AN UNUSED STENT. A NEPHROSTOMY BALLOON WAS PLACED AFTER THAT, THEN THE PROCEDURE WAS FINISHED. THE PLACED NEPHROSTOMY BALLOON IS SCHEDULED TO BE REMOVED IN ONE OR TWO DAYS AND THE FLOW OF URINE IS CHECKED IN ORDER TO DECIDE WHICH STENT, RMS- OR OTHER MODELS, SHOULD BE PLACED NEXT OR WHETHER WAIT-AND-SEE APPROACH WOULD BE PREFERABLE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED - REPORTING REQUIRED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION AS THE STENT BROKE ON REMOVAL FROM THE PATIENT AND THE PHYSICIAN "PLANS TO RETRIEVE THE REMAINED SEGMENT FROM THE RENAL PELVIS PERCUTANEOUSLY THROUGH THE NEPHROSTOMY ROUTE" NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES AFTER 12 MONTHS OF PLACEMENT. ONE STENT COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE PATIENT. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED ON 30/OCT/2018, ON (B)(6) 2017 (EXACT DATE UNKNOWN): RMS-060022-R/ LOT#: C1296687 (COMPLAINT DEVICE) AND RMS-060022-R/ LOT#: C1307377 WERE PLACED IN THE RIGHT AND LEFT SIDES RESPECTIVELY. THERE HAD BEEN NO PROBLEM OBSERVED IN THE RENAL FUNCTION AND DEVICES PERFORMANCE OF DRAINAGE DURING PLACEMENT. ON (B)(6) 2018: RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES. ONE STENT (C1307377) COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT (C1296687) AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE RENAL PELVIS. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. AS OF ON (B)(6) 2018: THE PATIENT HAD A FAVORABLE OUTCOME WITHOUT BLEEDING AFTER STENTS EXCHANGE. THE PHYSICIAN HAS A PLAN TO RETRIEVE THE REMAINED SEGMENT FROM THE RENAL PELVIS PERCUTANEOUSLY THROUGH THE NEPHROSTOMY ROUTE SINCE THE PRE EXISTING DISEASE IS RETROPERITONEAL FIBROSIS WHICH IS BENIGN AND GOOD PROGNOSIS CAN BE EXPECTED. HOWEVER, THE PATIENT DOES NOT PARTICULARLY REQUIRE EXTRACTION OF THE REMAINED SEGMENT SINCE NO PROBLEM HAS OCCURRED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2018, (B)(6). IT WAS CONFIRMED WITH THE PHYSICIAN THAT THE REMAINED SEGMENT WOULD BE RETRIEVED FROM THE PATIENT VIA THE PERCUTANEOUS APPROACH ON (B)(6) 2019. THE SEGMENT WILL BE RETURNED TO COOK FOR INVESTIGATION. ADDITIONAL INFORMATION (25/JAN/2019, (B)(6). ON (B)(6) 2019: THE RMS- STENT WHICH HAD BEEN PLACED ON (B)(6) 2018 AFTER THE REPORTED EVENT WAS REMOVED TRANSURETHRALLY WITH NO PROBLEM. ON (B)(6) 2019: THE PHYSICIAN PERFORMED RETRIEVAL OF THE REMAINED SEGMENT AS PLANNED. THE PATIENT CONDITIONS INCLUDING RENAL FUNCTION HAD BEEN EXCELLENT. A NEPHROSTOMY TRACT WAS ESTABLISHED WITH AN ULTRAXX NEPHROSTOMY BALLOON PERCUTANEOUSLY. THOUGH THE TIP OF THE REMAINED SEGMENT LOOKED AS IF IT HAD BEEN EMBEDDED IN THE DISTAL RENAL CALIX UNDER FLUOROSCOPIC GUIDANCE PRIOR TO ESTABLISHING THE NEPHROSTOMY TRACT, PYELOSCOPE SHOWED THE SEGMENT RIGHT IN FRONT, WHICH MADE THE PHYSICIAN IMPOSSIBLE TO OBSERVE HOW THE TIP HAD BEEN POSITIONED. THE SEGMENT WAS RETRIEVED WITH FORCEPS SUCCESSFULLY AND FOUND TO BE SO CLEAN AS IT LOOKED LIKE AN UNUSED STENT. A NEPHROSTOMY BALLOON WAS PLACED AFTER THAT, THEN THE PROCEDURE WAS FINISHED. THE PLACED NEPHROSTOMY BALLOON IS SCHEDULED TO BE REMOVED IN ONE OR TWO DAYS AND THE FLOW OF URINE IS CHECKED IN ORDER TO DECIDE WHICH STENT, RMS- OR OTHER MODELS, SHOULD BE PLACED NEXT OR WHETHER WAIT-AND-SEE APPROACH WOULD BE PREFERABLE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES AFTER 12 MONTHS OF PLACEMENT. ONE STENT COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE PATIENT. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED ON 30/OCT/2018, (B)(6) 2017 (EXACT DATE UNKNOWN): RMS-060022-R/ LOT# C1296687 (COMPLAINT DEVICE) AND RMS-060022-R/ LOT# C1307377 WERE PLACED IN THE RIGHT AND LEFT SIDES RESPECTIVELY. THERE HAD BEEN NO PROBLEM OBSERVED IN THE RENAL FUNCTION AND DEVICES PERFORMANCE OF DRAINAGE DURING PLACEMENT. (B)(6) 2018: RMS- STENT EXCHANGE WAS PERFORMED ON BOTH RIGHT AND LEFT SIDES. ONE STENT (C1307377) COULD BE REMOVED WITH NO PROBLEM, THEN EXCHANGED. THE PHYSICIAN ATTEMPTED TO REMOVE ANOTHER STENT (C1296687) AS WELL AFTER GRASPING THE STENT WITH FORCEPS, BUT HE FELT RESISTANCE DURING THE ATTEMPT OF STENT REMOVAL. HE MANAGED TO REMOVE THE STENT, BUT IT BROKE AT THE RENAL SIDE AND THE SEPARATED SEGMENT REMAINED INSIDE THE RENAL PELVIS. NO TREATMENT WAS CONDUCTED AT PHYSICIAN'S JUDGMENT AND A NEW RMS- STENT WAS PLACED TO COMPLETE THE PROCEDURE. AS OF (B)(6) 2018: THE PATIENT HAD A FAVORABLE OUTCOME WITHOUT BLEEDING AFTER STENTS EXCHANGE. THE PHYSICIAN HAS A PLAN TO RETRIEVE THE REMAINED SEGMENT FROM THE RENAL PELVIS PERCUTANEOUSLY THROUGH THE NEPHROSTOMY ROUTE SINCE THE PRE EXISTING DISEASE IS RETROPERITONEAL FIBROSIS WHICH IS BENIGN AND GOOD PROGNOSIS CAN BE EXPECTED. HOWEVER, THE PATIENT DOES NOT PARTICULARLY REQUIRE EXTRACTION OF THE REMAINED SEGMENT SINCE NO PROBLEM HAS OCCURRED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938541 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD | G34109 | C1296687 | 10827002341095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |