BILIARY STENT
Report
- Report Number
- 3001845648-2019-00693
- Event Type
- Injury
- Date Received
- December 9, 2019
- Report Date
- April 7, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CONTACT PERSON: N.L. LEE. USER FACILITY: DEPARTMENT OF RADIOLOGY, UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, ASAN MEDICAL CENTER, 88, OLYMPIC-RO 43-GIL , SONGPA-GU, SEOUL 05505 , REPUBLIC OF KOREA. DEPARTMENT OF GAST ROENTEROLOGY , UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, ASAN MEDICAL CENTER, SEOUL, REPUBLIC OF KOREA. A 510(K) NUMBER CANNOT BE PROVIDED AS THE RPN IS UNKNOWN. DEVICE EVALUATION: THE UNKNOWN DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. NINETY PATIENTS WERE INCLUDED. TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE. SEE "LEE NJ TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING.PDF" THE PURPOSE OF THIS STUDY WAS TO REPORT THE INCIDENCE OF MASSIVE BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED TRANSMURAL PANCREATICOBILIARY DRAINAGE (EUS-TPBD) AND THE CLINICAL OUTCOMES IN PATIENTS WITH THIS CONDITION TREATED WITH TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). ALL EUS-TPBD PROCEDURES WERE PERFORMED BY EXPERT GASTROINTESTINAL ENDOSCOPISTS. EUS-TPBD WAS CARRIED OUT USING A GF-UCT 240 LINEAR-ARRAY ECHOENDOSCOPE (OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND WAS PERFORMED BY DIRECTLY PUNCTURING THE DILATED INTRAHEPATIC BILIARY SYSTEM, PROXIMAL COMMON BILE DUCT OR PANCREATIC DUCT WITH A 19-GAUGE NEEDLE (EUSN-19-T; COOK ENDOSCOPY, WINSTON-SALEM, NC). THEN, THE TRACT WAS DILATED USING A 4 MM BALLOON DILATATION CATHETER, AND A 4F CANNULA (GLO-TIP, GT-1-UT; COOK) WAS ADVANCED OVER THE GUIDEWIRE. FINALLY, A PLASTIC STENT (DOUBLE PIG TAIL, COOK MEDICAL, WINSTON-SALEM, NC), A FULLY COVERED SELF EXPANDABLE METAL STENT (MITECH, FC GROUP SEOUL, KOREA) OR A HYBRID STENT (BONA, STANDARD SCI TECH, SEOUL, KOREA) WAS THEN DEPLOYED OVER THE GUIDEWIRE. THIS FILE (B)(4) WAS OPENED TO INVESTIGATION THE TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE ADVERSE EFFECTS REPORT IN THE ARTICLE. INVESTIGATION (B)(4) WAS CREATED TO CAPTURE OFF LABEL USE AS A DOUBLE PIGTAIL BILIARY STENT WAS USED FOR PANCREATICOBILIARY DRAINAGE. CONSIDERED AS OFF-LABEL USE. LAB EVALUATION: N/A. IMAGE REVIEW: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL ZIMMON BILIARY STENT 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. (D00059776 [QSI0975] REV.031, D00052025 [PRD0086] REV.081 AND D00055291 [FQC0144] REV.016). A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIMMON BILIARY STENT STENT DEVICES COULD NOT BE COMPLETE AS THE LOT NUMBERS ARE UNKNOWN. AS PER INSTRUCTIONS FOR USE, IFU0045-7, INTENDED USE SECTION: ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ NOTES SECTION: ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ IT MAY BE NOTED THAT FILE WAS CREATED TO CAPTURE THE OFF LABEL USE THAT A BILIARY STENT WAS USED AS TRANSMURAL DRAINAGE FOR PFCS (PERIPANCREATIC FLUID COLLECTIONS). AS COOK ONLY HAVE A DOUBLE PIGTAIL BILIARY STENT NOT A PANCREATIC STENT, IT HAS BEEN ASSUMED THIS IS A BILIARY STENT AND IS THEREFORE USED OFF LABEL. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. TWO PATIENTS EXPERIENCED MAJOR BLEEDING REQUIRING SECONDARY INTERVENTION I.E., TAE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
A 510(K) NUMBER CANNOT BE PROVIDED AS THE RPN IS UNKNOWN. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EVENT REPORTED AS LITERATURE - ARTICLE IS ATTACHED. TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE. THE PURPOSE OF THIS STUDY WAS TO REPORT THE INCIDENCE OF MASSIVE BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED TRANSMURAL PANCREATICOBILIARY DRAINAGE (EUS-TPBD) AND THE CLINICAL OUTCOMES IN PATIENTS WITH THIS CONDITION TREATED WITH TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). ALL EUS-TPBD PROCEDURES WERE PERFORMED BY EXPERT GASTROINTESTINAL ENDOSCOPISTS. EUS-TPBD WAS CARRIED OUT USING A GF-UCT 240 LINEAR-ARRAY ECHOENDOSCOPE (OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND WAS PERFORMED BY DIRECTLY PUNCTURING THE DILATED INTRAHEPATIC BILIARY SYSTEM, PROXIMAL COMMON BILE DUCT OR PANCREATIC DUCT WITH A 19-GAUGE NEEDLE (EUSN-19-T; COOK ENDOSCOPY, WINSTON-SALEM, NC). THEN, THE TRACT WAS DILATED USING A 4 MM BALLOON DILATATION CATHETER, AND A 4F CANNULA (GLO-TIP, GT-1-UT; COOK) WAS ADVANCED OVER THE GUIDEWIRE. FINALLY, A PLASTIC STENT (DOUBLE PIG TAIL, COOK MEDICAL, WINSTON-SALEM, NC), A FULLY COVERED SELFEXPANDABLE METAL STENT (MITECH, FC GROUP SEOUL, KOREA) OR A HYBRID STENT (BONA, STANDARD SCI TECH, SEOUL, KOREA) WAS THEN DEPLOYED OVER THE GUIDEWIRE. 90 PATIENTS HAD A PLASTIC STENT INSERTED. TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE. THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ON THE ASSUMPTION INTERVENTION WAS REQUIRED AS TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE.
EVENT REPORTED AS LITERATURE. TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE. THE PURPOSE OF THIS STUDY WAS TO REPORT THE INCIDENCE OF MASSIVE BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED TRANSMURAL PANCREATICOBILIARY DRAINAGE (EUS-TPBD) AND THE CLINICAL OUTCOMES IN PATIENTS WITH THIS CONDITION TREATED WITH TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). ALL EUS-TPBD PROCEDURES WERE PERFORMED BY EXPERT GASTROINTESTINAL ENDOSCOPISTS. EUS-TPBD WAS CARRIED OUT USING A GF-UCT 240 LINEAR-ARRAY ECHOENDOSCOPE (OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND WAS PERFORMED BY DIRECTLY PUNCTURING THE DILATED INTRAHEPATIC BILIARY SYSTEM, PROXIMAL COMMON BILE DUCT OR PANCREATIC DUCT WITH A 19-GAUGE NEEDLE (EUSN-19-T; COOK ENDOSCOPY, WINSTON-SALEM, NC). THEN, THE TRACT WAS DILATED USING A 4 MM BALLOON DILATATION CATHETER, AND A 4F CANNULA (GLO-TIP, GT-1-UT; COOK) WAS ADVANCED OVER THE GUIDEWIRE. FINALLY, A PLASTIC STENT (DOUBLE PIG TAIL, COOK MEDICAL, WINSTON-SALEM, NC), A FULLY COVERED SELFEXPANDABLE METAL STENT (MITECH, FC GROUP SEOUL, KOREA) OR A HYBRID STENT (BONA, STANDARD SCI TECH, SEOUL, KOREA) WAS THEN DEPLOYED OVER THE GUIDEWIRE. 90 PATIENTS HAD A PLASTIC STENT INSERTED. TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE. THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ON THE ASSUMPTION INTERVENTION WAS REQUIRED AS TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE.
A 510(K) NUMBER CANNOT BE PROVIDED AS THE RPN IS UNKNOWN. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EVENT REPORTED AS LITERATURE. TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE. THE PURPOSE OF THIS STUDY WAS TO REPORT THE INCIDENCE OF MASSIVE BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED TRANSMURAL PANCREATICOBILIARY DRAINAGE (EUS-TPBD) AND THE CLINICAL OUTCOMES IN PATIENTS WITH THIS CONDITION TREATED WITH TRANSCATHETER ARTERIAL EMBOLIZATION (TAE). ALL EUS-TPBD PROCEDURES WERE PERFORMED BY EXPERT GASTROINTESTINAL ENDOSCOPISTS. EUS-TPBD WAS CARRIED OUT USING A GF-UCT 240 LINEAR-ARRAY ECHOENDOSCOPE (OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND WAS PERFORMED BY DIRECTLY PUNCTURING THE DILATED INTRAHEPATIC BILIARY SYSTEM, PROXIMAL COMMON BILE DUCT OR PANCREATIC DUCT WITH A 19-GAUGE NEEDLE (EUSN-19-T; COOK ENDOSCOPY, WINSTON-SALEM, NC). THEN, THE TRACT WAS DILATED USING A 4 MM BALLOON DILATATION CATHETER, AND A 4F CANNULA (GLO-TIP, GT-1-UT; COOK) WAS ADVANCED OVER THE GUIDEWIRE. FINALLY, A PLASTIC STENT (DOUBLE PIG TAIL, COOK MEDICAL, WINSTON-SALEM, NC), A FULLY COVERED SELFEXPANDABLE METAL STENT (MITECH, FC GROUP SEOUL, KOREA) OR A HYBRID STENT (BONA, STANDARD SCI TECH, SEOUL, KOREA) WAS THEN DEPLOYED OVER THE GUIDEWIRE. 90 PATIENTS HAD A PLASTIC STENT INSERTED. TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE. THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15. BASED ON THE ASSUMPTION INTERVENTION WAS REQUIRED AS TWO CASES OF BLEEDING FOLLOWING DOUBLE PIGTAIL PLASTIC BILIARY STENT PLACEMENT FOR PANCREATICOBILIARY DRAINAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1231555 | BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |