RESONANCE STENT SET
Report
- Report Number
- 3001845648-2018-00386
- Event Type
- Injury
- Date Received
- August 16, 2018
- Date of Event
- July 20, 2018
- Report Date
- September 13, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FAD
- PMA / PMN Number
- K063742
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 WITH 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 TO MANUFACTURER SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: 1 X RMS-060024-R OF UNKNOWN LOT NUMBER WAS RETURNED TO CIRL FOR EVALUATION AND A LAB EVALUATION WAS HELD ON (B)(6) 2018. DURING THE LAB EVALUATION IT WAS NOTED THAT THE BALL WELD ON EITHER END OF THE STENT WAS MISSING AND THE STENT COIL WAS UN RAVELLED. IT WAS NOTED THAT THE DAMAGE TO THE STENT WAS LIKELY SUSTAINED DURING THE ATTEMPTED REMOVAL DURING TISSUE INGROWTH. DOCUMENTS REVIEW: A REVIEW OF MANUFACTURING RECORDS AND COMPLAINTS HISTORY FOR THE METAL RESONANCE STENT SET RMS-060024-R INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IMAGE REVIEW: OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: 1. SIGNIFICANT TISSUE INGROWTH OF THE RENAL PELVIC PORTION OF A RESONANCE STENT AFTER A REPORTED DWELL TIME OF 9-10 MONTHS, RESULTING IN DIFFICULTY IN RETRIEVAL WITH UTILIZATION OF A LASER AND INADVERTENTLY CAUSING A FRACTURE OF THE STENT WITH THE PELVIC PORTION REMAINING IN THE PATIENT. FIVE, POOR QUALITY URETEROSCOPIC IMAGES, ALONG WITH THE COMPLAINT REPORT, WERE SUBMITTED FOR REVIEW. SIGNIFICANT TISSUE INGROWTH OF THE RENAL PELVIC PORTION OF A RESONANCE STENT AFTER A REPORTED DWELL TIME OF 9-10 MONTHS, RESULTING IN DIFFICULTY IN RETRIEVAL WITH UTILIZATION OF A LASER AND INADVERTENTLY CAUSING A FRACTURE OF THE STENT WITH THE PELVIC PORTION REMAINING IN THE PATIENT. THE FIVE, VERY POOR QUALITY, URETEROSCOPIC IMAGES DEMONSTRATE A RESONANCE METALLIC URETERAL STENT IN WHAT APPEARS TO BE THE RENAL PELVIS AND URETER. THERE IS TISSUE INGROWTH AND POTENTIAL EARLY ENCRUSTATION ALONG WHAT APPEARS TO BE THE PIGTAIL PORTION/PROXIMAL PORTION OF THE URETERAL STENT. THE MORE DISTAL PORTION/URETERIC PORTION OF THE STENT APPEARS TO BE FREE OF THIS TISSUE INGROWTH, BUT DOES APPEAR TO HAVE MINIMAL ENCRUSTATION DUE TO THE DEBRIS PRESENT. IMPRESSION: INDICATION FOR UTILIZATION OF THE RESONANCE URETERAL STENT WAS NOT DISCUSSED IN THE COMPLAINT REPORT. PER THE COMPLAINT REPORT, THE STENT HAD BEEN IN THE PATIENT FOR 9 TO 10 MONTHS. WHEN THE UROLOGIST WENT TO REMOVE THE RESONANCE STENT, THEY WERE UNABLE TO DO SO AS THE PIGTAIL PORTION WITHIN THE RENAL PELVIS WAS IMPACTED AND DEMONSTRATED SIGNIFICANT TISSUE INGROWTH. ATTEMPTS AT LASER REMOVAL OF THE STENT WERE UNSUCCESSFUL, EVENTUALLY BREAKING THE STENT WITH THE LASER. THE DISTAL COMPONENT OF THE STENT WAS REMOVED, HOWEVER, THE FRAGMENT THAT DEMONSTRATED SIGNIFICANT INTERVAL INGROWTH WAS LEFT IN PLACE IN THE RENAL PELVIS. THE IMAGES SUBMITTED ARE OF VERY POOR QUALITY BUT DO DEMONSTRATE SIGNIFICANT TISSUE INGROWTH IN THE AREA OF THE RENAL PELVIS AS WELL AS EARLY ENCRUSTATION OF THE URETERAL COMPONENT OF THE STENT. THE IFU DESCRIBES THE STENT AS BEING A TEMPORARY DEVICE, AND THE STENT MAY REMAIN IN THE PATIENT FOR UP TO 12 MONTHS. HOWEVER, IT IS NOTED THAT INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN THE STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE AND THAT TISSUE INGROWTH AND STENT ENCRUSTATION ARE POTENTIAL ADVERSE EVENTS. IN THIS CASE, THE IRRITATION OF THE RENAL PELVIS DUE TO THE URETERAL STENT RESULTED IN SIGNIFICANT TISSUE INGROWTH AND EARLY SIGNS TO SUGGEST STENT ENCRUSTATION. THIS TISSUE INGROWTH CAUSED SIGNIFICANT DIFFICULTY IN ATTEMPTED RETRIEVAL, CONTRIBUTING TO A FRACTURE OF THE STENT WHILE USING THE LASER. IT COULD BE ARGUED THAT OTHER MANEUVERS TO REMOVE THE STENT MAY NOT HAVE RESULTED IN A FRACTURE, BUT GIVEN THE DEGREE OF INGROWTH SEEN, THIS IS UNCERTAIN. POTENTIALLY, EARLIER REMOVAL OF THE STENT MAY HAVE ALSO AVOIDED THIS SCENARIO, BUT GIVEN THE REPORTED DWELL TIME IS WITHIN THE RECOMMENDED TIME FRAME IN THE IFU, THIS WOULD NOT HAVE LIKELY OCCURRED, UNLESS THE PATIENT WAS SYMPTOMATIC. THE CAUSE OF THE INGROWTH IS LIKELY MULTIFACTORIAL AND RELATED TO THE DEVICE MATERIAL, SHAPE, POSITION WITHIN THE RENAL PELVIS AND THE PATIENT¿S ANATOMY/BIOLOGY. DIFFERENTIATING WHICH OF THESE CONTRIBUTING FACTORS WAS MOST RESPONSIBLE FOR THE INGROWTH IS NOT POSSIBLE. IFU REVIEW: ACCORDING TO THE INSTRUCTIONS FOR USE TISSUE INGROWTH IS LISTED AS A POTENTIAL ADVERSE EVENT. ACCORDING TO THE INSTRUCTIONS FOR USE THE USER IS INSTRUCTED THAT ¿PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAYS (KUB FILM). PATIENTS USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION¿, AND THAT ¿INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE¿, AND ALSO ¿USE OF THIS DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PATIENT¿ AND TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. ACCORDING TO CLINICAL INPUT A POSSIBLE ROOT CAUSE COULD BE MULTIFACTORIAL AND RELATED TO THE DEVICE MATERIAL, SHAPE, POSITION WITHIN THE RENAL PELVIS AND THE PATIENT¿S ANATOMY/BIOLOGY. DIFFERENTIATING WHICH OF THESE CONTRIBUTING FACTORS WAS MOST RESPONSIBLE FOR THE INGROWTH IS NOT POSSIBLE. IT SHOULD ALSO BE NOTED THAT THE USER IS INSTRUCTED TO CAREFULLY MONITOR THE PATIENT DURING INDWELLING TIME AS PATIENT- STENT INTERACTIONS ARE UNPREDICTABLE AND THAT EARLIER REMOVAL OF THE STENT MAY HAVE ALSO AVOIDED THIS SCENARIO. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGES. PRDS/FQC REVIEW: PRIOR TO DISTRIBUTION ALL RMS-060024-R DEVICES ARE SUBJECT TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY, THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. MANUFACTURING TEAM MEMBERS ARE INSTRUCTED TO " CHECK FOR KINKS OR DAMAGE ALONG STENT LENGTH. ¿ AND TO ¿TUG AT BOTH ENDS OF THE STENT TO CONFIRM THE INNER WIRE TO COILED WIRE CONNECTION". THERE IS ALSO 100% VISUAL INSPECTION OF PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC AND POST STERILE QC. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
AS REPORTED TO CUSTOMER RELATIONS "THEY WENT TO REMOVE THE INITIAL RESONANCE STENT. THEY WERE UNABLE TO DO SO BECAUSE THE PIGTAIL IN THE KIDNEY WAS IMPACTED IN THE RENAL PELVIS. THE TISSUE HAD GROWN AROUND THE STENT. THEY THEN TRIED TO LASER OFF THE TISSUE. THEY WERE UNSUCCESSFUL. THEY ENDED UP BREAKING THE STENT WITH THE LASER. THEY REMOVED THE PART OF THE STENT THAT IS BEING RETURNED. PART OF HE PIGTAIL REMAINS IN THE PATIENT. THE DOCTOR MAY HAVE THE PATIENT COME BACK TO HAVE THE PIGTAIL REMOVED. THEY THEN PLACED A UNIVERSA FIRM STENT IN THE PLACE WHERE THE RESONANCE STENT HAD BEEN."
AS REPORTED TO CUSTOMER RELATIONS "THEY WENT TO REMOVE THE INITIAL RESONANCE STENT. THEY WERE UNABLE TO DO SO BECAUSE THE PIGTAIL IN THE KIDNEY WAS IMPACTED IN THE RENAL PELVIS. THE TISSUE HAD GROWN AROUND THE STENT. THEY THEN TRIED TO LASER OFF THE TISSUE. THEY WERE UNSUCCESSFUL. THEY ENDED UP BREAKING THE STENT WITH THE LASER. THEY REMOVED THE PART OF THE STENT THAT IS BEING RETURNED. PART OF HE PIGTAIL REMAINS IN THE PATIENT. THE DOCTOR MAY HAVE THE PATIENT COME BACK TO HAVE THE PIGTAIL REMOVED. THEY THEN PLACED A UNIVERSA FIRM STENT IN THE PLACE WHERE THE RESONANCE STENT HAD BEEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630284 | RESONANCE STENT SET | FAD STENT, URETERAL | FAD | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |