ZIMMON BILIARY STENT
Report
- Report Number
- 3001845648-2022-00313
- Event Type
- Injury
- Date Received
- June 1, 2022
- Date of Event
- March 21, 2011
- Report Date
- September 30, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION: 10 X ZSO-7-15 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, ¿"LEE T H. ET AL., 2011, ZIMMON BILIARY STENT, OUTCOMES OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING FOR SYMPTOMATIC GALLBLADDER DISEASES: A MULTICENTER PROSPECTIVE FOLLOW-UP STUDY". DOCUMENT REVIEW AS THE LOT NUMBER OF THE PLASTIC STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZSO-7-15 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. IN THIS JOURNAL, A TOTAL OF 10 PATIENTS HAD: PANCREATITIS (MILD PANCREATITIS (N=2) AND MILD POST-ERCP PANCREATITIS DEVELOPED (N =2) ), STENT MIGRATION (DISTAL MIGRATION (N = 2), CHOLESTASIS (N=2), RECURRENT BILIARY PAIN (N=1) AND CHOLANGITIS (N=1). IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045) THAT ACCOMPANY THE DEVICE STATES: THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS. DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THERE IS EVIDENCE FROM THE JOURNAL TO STATE THAT THE USER DIDN¿T FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. PLACEMENT OF THE DEVICE TO STENT THE GALLBLADDER IS CONSIDERED OFF-LABEL USE AS PER THE IFU, THE DEVICE'S INTENDED USE IS TO DRAIN OBSTRUCTED BILIARY DUCTS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED IN THE JOURNAL, PANCREATITIS (MILD PANCREATITIS (N=2) AND MILD POST-ERCP PANCREATITIS DEVELOPED (N =2) ), STENT MIGRATION (DISTAL MIGRATION (N = 2), CHOLESTASIS (N=2), RECURRENT BILIARY PAIN (N=1) AND CHOLANGITIS (N=1). AS PER MEDICAL ADVISOR INPUT, REINTERVENTION WAS REQUIRED FOR THE CASE OF MIGRATION (REF. ATT. 'LEE 2011 CLINICAL INPUT_WG_20MAY2022') COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
"LEE T H. ET AL., 2011, ZIMMON BILIARY STENT, OUTCOMES OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING FOR SYMPTOMATIC GALLBLADDER DISEASES: A MULTICENTER PROSPECTIVE FOLLOW-UP STUDY*. FOLLOWING AN OVERNIGHT FAST, ALL PATIENTS UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A STANDARD DUODENOSCOPE (TJF 240; OLYMPUS OPTICAL CO., LTD., TOKYO, JAPAN) IN THE PRONE OR LATERAL POSITION, AFTER SEDATION WITH INTRAVENOUS MIDAZOLAM (0.05 MG/KG) AND/OR PROPOFOL (0.5 MG/KG). PROPHYLACTIC ANTIBIOTICS AND ANALGESICS WERE PERMITTED (100 %). ACCESS TO THE CYSTIC DUCT AND GALLBLADDER WAS ATTEMPTED WITH ONE OF THE FOLLOWING GUIDE WIRES: A 0.035-INCH-DIAMETER, 450-CM-LONG HYDROPHILIC JAGWIRE CATHETER TIP (BOSTON SCIENTIFIC CORP., NATICK, MASSACHUSETTS, USA); A 0.035-INCH HYDROPHILIC RADIFOCUS GUIDE WIRE (STIFF TYPE, TERUMO, TOKYO, JAPAN); OR A 0.035-INCH-DIAMETER, 480-CM-LONG, HYDROPHILIC, SLIP-COAT TIP TRACER GUIDE WIRE (WILSON-COOK MEDICAL INC., WINSTON-SALEM, NORTH CAROLINA, USA), THROUGH CANNULATING CATHETERS, INCLUDING THE STANDARD CATHETER, PULL-SPHINCTEROTOME, OR ROTATING SPHINCTEROTOME (AUTOTOME RX; BOSTON SCIENTIFIC). AFTER SUCCESSFUL BILE DUCT CANNULATION, THE GUIDE WIRE-PRELOADED CATHETER WAS ADVANCED TO NEGOTIATE THE CYSTIC DUCT. THE DISTANCE BETWEEN THE GALLBLADDER AND THE DUODENUM WAS MEASURED BY PULLING THE CATHETER CONVENIENTLY OUTSIDE THE ENDOSCOPE UNTIL IT TRAVERSED FROM THE GALLBLADDER TO THE MAJOR DUODENAL PAPILLA. BASED ON THE MEASURED DISTANCE, A 7-FR, 7¿15-CM-LONG DOUBLE-PIGTAIL POLYETHYLENE PLASTIC STENT (ZIMMON; WILSON-COOK MEDICAL) WAS PLACED BETWEEN THE GALLBLADDER AND THE DUODENUM (¿"" FIG. 1). ENDOSCOPIC SPHINCTEROTOMY (EST) AND/OR ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) WERE PERFORMED IN PATIENTS WITH COMMON BILE DUCT (CBD) STONES, SUSPECTED CHOLEDOCHOLITHIASIS, OR CBD DILATATION (>8MM WITH GALLBLADDER IN SITU) WITH ABNORMAL LIVER BIOCHEMICAL TESTS, INCLUDING BILIRUBIN. ETGS WAS SUCCESSFUL IN 23 (79.3 %) OF THE 29 CANDIDATES. PROCEDURE-RELATED ADVERSE EVENTS IN THE ETGS GROUP WERE MILD PANCREATITIS (2/23, 8.7 %) AND CHOLESTASIS (2/23, 8.7 %). MILD POST-ERCP PANCREATITIS DEVELOPED IN TWO PATIENTS WHO DID NOT UNDERGO EST OR EPBD (P = 0.012) EST AND/OR EPBD WERE PERFORMED IN 20 PATIENTS (87 %) WHO HAD CBD STONES (N = 10), SUSPECTED CHOLEDOCHOLITHIASIS (N = 4), AND CBD DILATATION (N = 6). THREE PATIENTS WHO DID NOT UNDERGO EST OR EPBD HAD CALCULOUS CHOLECYSTITIS (N = 2) AND BILIARY PAIN (N = 1) WITH NORMAL CBD AND LIVER CHEMISTRY. CHOLESTATIC LIVER DYSFUNCTION WITH NO EVIDENCE OF CHOLANGITIS DEVELOPED IN TWO PATIENTS WHO DID NOT UNDERGO EST OR EPBD. HOWEVER, ALL OF THESE RESOLVED WITH CONSERVATIVE MANAGEMENT. DURING THE FOLLOW-UP PERIOD (MEDIAN 586, RANGE 11¿1403 DAYS), THREE PATIENTS WERE EXCLUDED DUE TO UNRELATED DEATH: COMPLICATION OF LUNG CANCER (11 DAYS), LIVER TRANSPLANTATION (303 DAYS), AND STENT REMOVAL BY DEMAND OF THE PATIENT (850 DAYS). DELAYED ADVERSE EVENTS DEVELOPED IN FOUR PATIENTS (20 %), INCLUDING DISTAL MIGRATION (N = 2), CHOLANGITIS (N = 1), AND RECURRENT BILIARY PAIN (N = 1). SPONTANEOUS DISTAL MIGRATION OCCURRED IN TWO PATIENTS, WHO HAD UNDERGONE SPHINCTEROTOMY (P = 1.00), AT 7 MONTHS AFTER ETGS. ONE PATIENT CONTINUED TO HAVE RECURRENT BILIARY PAIN WITHOUT STONES AT 12 MONTHS AFTER ETGS, AND ANOTHER PATIENT, WHO HAD NOT UNDERGONE SPHINCTEROTOMY, DEVELOPED CHOLANGITIS WITH CHOLEDOCHOLITHIASIS 19 MONTHS AFTER ETGS. MIGRATED OR COMPLICATED STENTS WERE REMOVED WITHOUT STENT EXCHANGE, AND PATIENTS REMAINED UNDER OUTPATIENT OBSERVATION WITHOUT ADVERSE EVENTS. IN TOTAL, CLINICALLY SIGNIFICANT ADVERSE EVENTS DEVELOPED IN THREE PATIENTS (TWO DISTAL MIGRATION, ONE RECURRENT BILIARY PAIN) IN THE EST OR EPBD GROUP AND THREE PATIENTS (TWO MILD PANCREATITIS AND ONE CHOLANGITIS) IN THE NO EST OR EPBD GROUP (P < 0.05). HOWEVER, THERE WAS NO DIFFERENCE IN EVENT-FREE INTERVAL BETWEEN PATIENTS WHO UNDERWENT EST OR EPBD AND THOSE WHO DID NOT (P = 0.397). THE REMAINING 16 PATIENTS WERE FOLLOWED FOR MORE THAN 12 MONTHS, AND NINE OF THESE WERE FOLLOWED FOR MORE THAN 24 MONTHS WITHOUT SIGNIFICANT ADVERSE EVENTS. SCHEDULED STENT EXCHANGE OR REMOVAL WAS NOT PERFORMED IN OUR STUDY. THIS FILE WAS OPENED TO CAPTURE: PANCREATITIS (MILD PANCREATITIS (N=2) AND MILD POST-ERCP PANCREATITIS DEVELOPED (N =2) ), STENT MIGRATION (DISTAL MIGRATION (N = 2), CHOLESTASIS (N=2), RECURRENT BILIARY PAIN (N=1) AND CHOLANGITIS (N=1) IT CAN BE NOTED THAT THE ZIMMON BILIARY STENTS WERE USED OFF-LABEL AS THE STENT WAS USED TO STENT THE GALLBLADDER. AS PER IFU0045-7, 'THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.' RE-INTERVENTION REQUIRED.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 30-SEP-2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730267 | ZIMMON BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |