ZIMMON BILIARY STENT
Report
- Report Number
- 3001845648-2024-00464
- Event Type
- Injury
- Date Received
- August 13, 2024
- Date of Event
- April 1, 2018
- Report Date
- June 27, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "THE DEVELOPMENT OF ENDOSCOPIC TECHNIQUES FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS: A SINGLE-CENTER EXPERIENCE". THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO PRS: 437327, 437323, 437325, 437326, 437328. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ZSO-10-5 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0045 WHICH INFORMS THE USER ABOUT INTENDED USE ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ AS PER THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0045, WHICH INFORMS THE USER TO ¿THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. ATTEMPTS TO REPROCESS, RESTERILIZE, AND/OR REUSE MAY LEAD TO DEVICE FAILURE AND/OR TRANSMISSION OF DISEASE. DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045) THE USER IS ADVISED OF THE FOLLOWING POTENTIAL COMPLICATIONS IN THE IFU, (IFU0045). "THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, THE ZSO-10-5 DEVICE WAS USED IN A PROCEDURE TO PUNCTURE A WOPN (WALLED-OFF PANCREATIC NECROSIS), THIS WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0045) STATES "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED IN THE INTENDED USE.¿ AS PER IFU POTENTIAL ADVERSE EVENTS ¿HEMORRHAGE¿ IS A KNOWN POTENTIAL COMPLICATION. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 7 PATIENTS REQUIRED PACKED RED BLOOD CELL TRANSFUSIONS, ONE UNDERWENT ENDOVASCULAR EMBOLIZATION OF THE HEPATODUODENAL ARTERY PSEUDOANEURYSM, AND ONE PATIENT DIED BECAUSE OF SPLENIC ARTERY PSEUDOANEURYSM HEMORRHAGE. AS PER CLINICAL INPUT "THE COOK DEVICE WAS NOT RELATED TO THE DEATH MENTIONED IN THE ARTICLE." COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.
JAGIELSKI ET AL 2018 ¿ THE DEVELOPMENT OF ENDOSCOPIC TECHNIQUES FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS: A SINGLE-CENTER EXPERIENCE. THE STUDY GROUP COMPRISED 101 PATIENTS WITH SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS WHO UNDERWENT ENDOSCOPIC THERAPY IN OUR DEPARTMENT OVER A 5-YEAR PERIOD FROM 2011 TO 2015. IN ALL PATIENTS, AN ATTEMPT TO PERFORM TRANSMURAL DRAINAGE WAS MADE. THE PLACE OF THE TRANSMURAL TRACT WAS CHOSEN WITH EUS GUIDANCE. GASTROSTOMY(OR DUODENOSTOMY) WAS CREATED WITH THE USE OF GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE FISTULA FORMED BETWEEN THE GASTROINTESTINAL LUMEN AND NECROTIC CAVITY WAS SEQUENTIALLY DILATED WITH AN 8 MM OR 20 MM BALLOON DILATOR (BOSTON SCIENTIFIC). A 7FR OR 8FR NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND DOUBLE-PIGTAIL STENTS 7FR OR 8.5FR (ZSO-10-5, WILSON-COOK OR MAR FLOW) WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. WHEN THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED, SPHINCTEROTOMY WAS PERFORMED WITH AN OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME AND PANCREATIC STENT WAS PLACED (PASSIVE TRANSPAPILLARY DRAINAGE) TO BRIDGE THE LEAK¿5FR, 7FR, 8.5FR, OR 10FR (GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR MAR FLOW) (FIGURES 1(A)¿1(C)). THE STENT WAS THEN REPLACED WITH A NEW ONE AFTER 6, 12, AND 24 MONTHS OR UNTIL THE PANCREATIC DUCT LEAK WAS NO LONGER DEMONSTRATED. THIS COMPLAINT WAS OPENED TO CAPTURE GASTROINTESTINAL BLEEDING THAT WAS OBSERVED IN 9/101 (8.91%) PATIENTS .OFF LABEL USE OF THE ZSO STENT FOR WALLED-OFF PANCREATIC NECROSIS (WOPN) STENT DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. 7 PATIENTS REQUIRED PACKED RED BLOOD CELL TRANSFUSIONS, ONE UNDERWENT ENDOVASCULAR EMBOLIZATION OF THE HEPATODUODENAL ARTERY PSEUDOANEURYSM, AND ONE PATIENT DIED BECAUSE OF SPLENIC ARTERY PSEUDOANEURYSM HEMORRHAGE. AS PER CLINICAL INPUT "THE COOK DEVICE WAS NOT RELATED TO THE DEATH MENTIONED IN THE ARTICLE."
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 27 JUN 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1683418 | ZIMMON BILIARY STENT | FGE - STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | COOK IRELAND LTD | G21975 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |