EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2020-00301
- Event Type
- Injury
- Date Received
- May 18, 2020
- Report Date
- August 14, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231280
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATION: THE EVO-10-11-4-B DEVICE OF LOT NUMBER C1692898 INVOLVED IN THIS COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-10-11-4-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-4-B DEVICE OF LOT NUMBER C1692898 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1692898; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1692898. THE INSTRUCTIONS FOR USE IFU0056-5 WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLECYSTITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRACT OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (B)(4). IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IMPRESSION: 1. THE COMPLAINT OF BILIARY SEPSIS IS NOT CONFIRMED. THE PROVIDED IMAGE CONFIRMS CONSTRAINT OF THE EVO-10-11-4-B IN THE EXPECTED LOCATION OF THE CBD AS IT COURSES THROUGH THE PANCREATIC HEAD HOWEVER THIS DOES NOT CONFIRM BILIARY SEPSIS. THE STENT WAS PATENT IMMEDIATELY POST IMPLANTATION. 2. STENT CONSTRAINT WOULD BE EXPECTED FROM A PANCREATIC HEAD MASS PARTICULARLY WITHOUT PRE-OR POST-IMPLANTATION ANGIOPLASTY. AS PER IMAGES REVIEW, ¿THE LEFT MAIN BILIARY DUCT APPEARANCE SUGGESTING A FILLING DEFECT COULD HAVE ALSO REPRESENTED ARTIFACT FROM A DISTAL BILIARY DUCT SUPERIMPOSED ON THE LEFT MAIN BILIARY DUCT.¿ AS PER MEDICAL ADVISOR, " FILLING DEFECT¿ MEANS EXCESS TISSUE OR SUBSTANCE IN THE DISTAL BILIARY DUCT FROM A PREVIOUS ARTEFACT. IT WAS NOT RELATED TO EVO-B AS PER FIG.1 IN THE IMAGING REVIEW. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER IMAGING REVIEW: " THE LEFT MAIN BILIARY DUCT APPEARANCE SUGGESTING A FILLING DEFECT COULD HAVE ALSO REPRESENTED ARTIFACT FROM A DISTAL BILIARY DUCT SUPERIMPOSED ON THE LEFT MAIN BILIARY DUCT. (FIGURE 1) THESE CONTRAST COLLECTIONS INDICATE GREATER CONTRAST OPACIFICATION OF THE BILIARY TREE PRIOR TO THE PERFORMANCE OF THE PROVIDED IMAGE. THIS CONFIRMS THAT THE STENT WAS PATENT AT LEAST IMMEDIATELY POST IMPLANTATION." AS PER MEDICAL ADVISOR, "AS PER IMAGING REVIEW, THE SEPSIS WAS NOT STENT RELATED." SUMMARY: THE COMPLAINT IS NOT CONFIRMED AS THE ISSUES IDENTIFIED WERE DETERMINED NOT TO BE DEVICE RELATED. ACCORDING TO THE INITIAL REPORTER, THE SEPSIS DEVELOPED 2-3 DAYS AFTER THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
IT WAS NOTED ON (B)(6) 2020 THAT THE RPN (EVO-10-11-4-B) REFERENCED IN THE PREVIOUSLY SUBMITTED REPORT WAS INCORRECT. THE RPN IS EVO-10-11-6-B. PMA/510(K)#: K121430. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA VERBAL COMMUNICATION WITH THE DISTRICT MANAGER: TWO TO THREE DAYS AFTER THE PATIENT UNDERWENT AN ERCP PROCEDURE IN WHICH THE EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED, G23127, WAS USED, THE PATIENT HAD BILIARY SEPSIS. PATIENT OUTCOME: 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? PT 2 WAS AN OUTPT AND WAS D/C HOME FOLLOWING PROCEDURE. FELT WEAK OVER THE NEXT FEW DAYS WITH PROGRESSIVE LETHARGY AND ENCOURAGED TO GO TO HIS LOCAL ER. HE WAS ADMITTED TO ICU LOCALLY AND DX WITH GRAM NEG SEPSIS ¿ THOUGH HIS LFTS WERE DECREASING, IT WAS THOUGHT THAT BILIARY SEPSIS WAS THE LIKELY ETIOLOGY IN THE ABSENCE OF OTHER CAUSES. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? IF YES, PLEASE DESCRIBE. PT 2: PRESENTED TO OSH AND WAS IN THEIR ICU. I DO NOT THINK THAT EITHER GI OR IR WAS CONSULTED BUT MY ABILITY TO REVIEW RECORDS FROM THIS HOSPITALIZATION IS LIMITED¿ 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES?NA IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NA. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NA. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: 2.1 GENERAL QUESTIONS: 2.1.1 AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? (WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) 2-3 DAYS POST PROCEDURE. 2.1.2 WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS TJF. 2.1.3 WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? NA. 2.1.4 DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? NA. 2.1.5 DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? THIS WAS 2-3 DAYS POST PROCEDURE. 2.1.6 HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 2-3 DAYS 2.1.7 FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? NA. FOR PT 2, I HAVE ATTACHED THE IMAGE IMMEDIATELY AFTER STENT PLACEMENT WHICH DEMONSTRATES A NARROWING, BUT NOT AS SEVERE AS IN CASE 1. I WOULD LIKE TO ASK IF DURING INITIAL PLACEMENT AFTER THE STENT WAS DEPLOYED, WAS THERE ANY ABNORMALITY TO THE FLUOROSCOPIC IMAGE, I AM REFERRING TO- WAS THERE ANY EXTREME NARROWING OF THE STENT WITHIN THE BILE DUCT? WAS THERE BILE SEEN EXITING THE BILE DUCT AFTER INITIAL PLACEMENT? YES IN BOTH CASES. WHEN THE PATIENTS PRESENTED WITH BILIARY SEPSIS- DID YOU REPEAT THE ERCP? NO, SEE BELOW¿ DID YOU OBTAIN FLUOROSCOPIC IMAGE OF INITIAL BILIARY METAL STENT? IF SO, WAS THERE ANY ABNORMALITY TO THAT FLUOROSCOPIC IMAGE? YES, SEE ATTACHED¿ DID THE STENT SHOW ANY EXTREME NARROWING WHICH WOULD SUGGEST BLOCKAGE OF THE BILE DUCT PREVENTING BILE FLOW? EXTREME NARROWING BUT HAVE SEEN THIS BEFORE¿AND THERE EVENTUALLY WAS ADEQUATE PALLIATION OF JAUNDICE SUGGESTING THAT THE STENT EXPANDED ADEQUATELY¿ IF YOU REPEATED THE ERCP ON THESE PATIENTS, WHAT ACTIONS DID YOU TAKE? WHAT TYPE OF THERAPY WAS PERFORMED. SEE BELOW. IF YOU HAVE ANY FLUOROSCOPIC IMAGES REGARDING THESE TWO PATIENTS COULD YOU PLEASE PROVIDE THEM WITH NO PATIENT IDENTIFIERS. 08MAY2020.
IT WAS NOTED ON (B)(6) 2020 THAT THE RPN (EVO-10-11-4-B) REFERENCED IN THE PREVIOUSLY SUBMITTED REPORT WAS INCORRECT. THE RPN IS EVO-10-11-6-B.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA VERBAL COMMUNICATION WITH THE DISTRICT MANAGER: TWO TO THREE DAYS AFTER THE PATIENT UNDERWENT AN ERCP PROCEDURE IN WHICH THE EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED, G23127, WAS USED, THE PATIENT HAD BILIARY SEPSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528650 | EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G23128 | C1692898 | 10827002231280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Life Threatening |