COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2018-00083
- Event Type
- Injury
- Date Received
- February 26, 2018
- Date of Event
- April 4, 2017
- Report Date
- February 26, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
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 PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS COMPLAINT IS RELATED TO (B)(4) WHEREBY 4 PATIENTS IN TOTAL HAD PERFORATION IN THE DUODENUM AS A RESULT OF STENT MIGRATION AFTER ERCP. FOR THE PURPOSE OF THE INVESTIGATION OF THESE COMPLAINTS (B)(4) REFERS TO CASE 1, (B)(4) REFERS TO CASE 2, (B)(4) REFERS TO CASE 3 AND (B)(4) REFERS TO CASE 4. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION FROM THE SALES REP CLARIFIED THAT THE PERFORATION WAS IN THE DUODENUM FOR ALL FOUR CASES INVOLVED IN THESE COMPLAINTS I.E (B)(4). THIS INVESTIGATION EVALUATION WILL DEAL WITH COMPLAINT NUMBER (B)(4) (CASE 1) . LAB EVALUATION: 2 X CLSO-10-18 DEVICES OF A UNKNOWN LOT NUMBER WERE INVOLVED IN THIS COMPLAINT. AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT CONFIRMED, A DOCUMENT BASED INVESTIGATION AND IMAGE REVIEW WAS COMPLETED FOR THIS COMPLAINT. IMAGING 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: FINDINGS: MULTIPLE IMAGES CONTAINED IN A PDF FORMAT, ALONG WITH THE COMPLAINT REPORT, WERE SUBMITTED FOR REVIEW. A SINGLE FLUOROSCOPIC IMAGE FROM AN ERCP WITHOUT DATE, CORONAL REFORMATTED CT SCAN OF THE ABDOMEN AND PELVIS WITH IV CONTRAST AND 2 FLUOROSCOPIC IMAGES FROM ERCP AT TIME OF STENT RETRIEVAL, DATED (B)(6) 2017, WERE SUBMITTED FOR REVIEW. IMAGES WILL BE DISCUSSED SEPARATELY. IMAGE 1 IS A FLUOROSCOPIC IMAGE PRESUMABLY FROM THE TIME OF BILIARY STENT PLACEMENT, NO DATE IS INCLUDED ON THE IMAGE. THERE ARE 2 PLASTIC BILIARY STENTS PRESENT, ONE DIRECTED TOWARDS THE LEFT HEPATIC LOBE, THE OTHER TOWARDS THE RIGHT HEPATIC LOBE. THE STENT DIRECTED TOWARDS THE RIGHT HEPATIC LOBE APPEARS KINKED AT THE ORIGIN OF THE PLASTIC FLAP. THE LEFTWARD DIRECTED STENT EXTENDS MEDIALLY OVER TO THE LEVEL OF THE RIGHT VERTEBRAL PEDICLES. THERE IS CONTRAST SEEN WITHIN THE INTRAHEPATIC BILIARY TREE, WHICH IS MILDLY DILATED. THERE IS GAS SEEN WITHIN THE COMMON BILE DUCT, WITH PRESUMABLE POINT OF STRICTURE AT THE HILUM ALTHOUGH NOT DEFINITIVELY SEEN ON THIS SINGLE IMAGE. THE CAUDAL ASPECTS OF THE STENT ARE NOT INCLUDED ON THIS IMAGE. CORONAL CT SCAN WITH IV CONTRAST, DEMONSTRATES THE DISTAL MARGINS OF BOTH OF THE BILIARY STENTS. ONE OF THE STENTS EXTENDS COMPLETELY OUTSIDE OF THE DUODENAL LUMEN. THE OTHER STENT APPEARS TO STOP AT THE WALL OF THE DUODENUM. THERE ARE INFLAMMATORY CHANGES WITHIN THE PERIDUODENAL FAT AND THERE IS MINIMAL AMOUNT OF ASCITES SEEN OUTLINING THE DOME OF THE LIVER AND IN THE LEFT ABDOMEN, SUGGESTING BILE IS LEAKING INTO THE PERITONEAL CAVITY. THE CRANIAL ASPECT OF THE STENT IS NOT INCLUDED ON THIS PLANE OF IMAGING. THE BILIARY TREE APPEARS DECOMPRESSED ON THIS SINGLE IMAGE. TWO FLUOROSCOPIC IMAGES FROM ERCP, AT THE TIME OF BILIARY STENT RETRIEVAL, AGAIN DEMONSTRATE THE 2 BILIARY STENTS. THE PLASTIC STENT DIRECTED TOWARDS THE RIGHT LOBE OF THE LIVER HAS BEEN DISPLACED CAUDALLY, WITH THE CRANIAL ASPECT NOW TERMINATING JUST SUPERIOR TO THE 11TH RIB MARGIN, WHERE ON THE PREVIOUS ERCP IMAGE THE PLASTIC FLAP STOPPED ABOVE THE 11TH RIB MARGIN. THE CAUDAL ASPECT OF THE STENT HAS MIGRATED INFERIORLY AND CORRELATES WITH THE FINDINGS SEEN ON THE CT SCAN. THE ENTIRE PLASTIC FLAP AND CAUDAL ASPECT OF THE STENT PROJECT OUTSIDE OF THE AIR SEEN WITHIN THE DUODENAL LUMEN, INDICATING PERFORATION. THE LEFTWARD DIRECTED STENT HAS ALSO MIGRATED CAUDALLY AND NOW NO LONGER PROJECTS OVER THE RIGHT PEDICLES BUT HAS RETRACTED SEVERAL CENTIMETERS. THE CAUDAL ASPECT OF THE STENT APPEARS TO PROJECT JUST BARELY OUTSIDE OF THE AIR SEEN WITHIN THE DUODENUM AND MAY REPRESENT THE CAUDAL MARGIN OF THE STENT IMBEDDED IN THE WALL OF THE DUODENUM VERSUS JUST BARELY PERFORATING THROUGH THE WALL. THE SECOND IMAGE DEMONSTRATES CONTRAST INJECTED INTO THE BILIARY TREE, DEMONSTRATING THE BIRD BEAK LIKE STENOSIS OCCURRING AT THE LEVEL OF THE 11TH RIB, CORRESPONDING TO THE HILAR STENOSIS PREVIOUSLY TREATED WITH THE STENTS. THIS IS THE LEVEL AT WHICH THE RIGHT SIDED STENT HAD STOPPED DURING THE CAUDAL MIGRATION. THERE IS AN OVER THE SCOPE CLIP SEEN ALONG THE INFERIOR MARGIN OF THE X-RAY INDICATING ITS USE TO CLOSE THE PERFORATED DUODENUM. IMPRESSION: PER THE COMPLETE REPORT, THE ERCP AND PLACEMENT OF RIGHT LEFT BILIARY STENTS WAS PERFORMED DUE TO A HILAR STENOSIS. THERE IS NO DISCUSSION WHETHER THIS STENOSIS WAS MALIGNANT OR BENIGN. THE COMPLAINT REPORT DESCRIBES THE DETECTION OF PERFORATION 6 DAYS AFTER ERCP, HOWEVER, THE DATE OF THE INITIAL ERCP IMAGES IS NOT INCLUDED ON THE IMAGE TO CONFIRM THIS. THE FOLLOW-UP ERCP IMAGES AT THE TIME OF STENT RETRIEVAL APPEAR TO HAVE OCCURRED 1 DAY AFTER THE ABDOMINAL CT SCAN DEMONSTRATED PERFORATION OF THE DUODENAL WALL. THE INITIAL ERCP IMAGE DEMONSTRATES THE CRANIAL ASPECT OF STENT PLACEMENT IN THE INTRAHEPATIC BILIARY TREE DIRECTED TOWARDS THE RIGHT AND LEFT LOBES OF THE LIVER. THE RIGHT DIRECTED STENT APPEARS BENT ON ITSELF, AT THE ORIGIN OF THE PLASTIC FLAP. LEFT STENT EXTENDS INTO THE INTRAHEPATIC BILIARY TREE SEVERAL CENTIMETERS TOWARDS THE LEFT. THE EXACT POINT OF HILAR STENOSIS AND THE LENGTH OF THE STENOSIS IS NOT DEPICTED ON THE STUDY. FURTHERMORE, THE CAUDAL ASPECTS OF THE STENT ARE NOT INCLUDED ON THIS IMAGE. THE FOLLOW-UP CT SCAN DEMONSTRATES PERFORATION OF AT LEAST ONE OF THE STENTS THROUGH THE WALL OF THE DUODENUM WITH ABDOMINAL ASCITES PRESENT, SUGGESTING LEAKAGE OF BILE INTO THE PERITONEAL SPACE. THE LEFTWARD DIRECTED STENT APPEARS TO STOP AT THE WALL OF THE DUODENUM OR EXTEND JUST PAST THE WALL, SUGGESTING IT IS EITHER PERFORATED AS WELL, OR AT LEAST EMBEDDED IN THE WALL OF THE DUODENUM. THE FOLLOW-UP ERCP IMAGES AT THE TIME OF STENT RETRIEVAL DEMONSTRATE CAUDAL MIGRATION OF THE 2 STENTS BY SEVERAL CENTIMETERS, RELATIVE TO THE CRANIAL ASPECT OF THE METALIC STENT. IT APPEARS THE STENTS HAVE MIGRATED TO THE LEVEL OF THE STENOSIS AS SEEN ON FOLLOW-UP ERCP IMAGE. THE STENT IS EXTREMELY LONG, AND ALTHOUGH NO IMAGES OF THE CAUDAL ASPECT OF THE STENT WERE SUBMITTED FROM THE TIME OF STENT PLACEMENT, GIVEN THE LENGTH, THE CAUDAL ASPECTS OF THE STENT WOULD HAVE LIKELY TERMINATED AGAINST THE LATERAL WALL OF THE DUODENUM DURING THE INITIAL PLACEMENT, IN A NEAR PERPENDICULAR FASHION. THE STENT LENGTH AND INTERACTION WITH THE LATERAL WALL OF THE DUODENUM AT THE INITIAL PLACEMENT, COMBINED WITH THE BEND IN THE CRANIAL ASPECT OF THE RIGHT STENT WHICH LIKELY RESULTED IN INTRINSIC DOWNWARD FORCES PLACED ON THE STENT, ALONG WITH BREATHING MOTION, AND NON-COMPRESSIBLE NATURE OF THE STENT ALONG ITS LONG ACCESS, RESULTED IN THE RAPID PERFORATION OF THE DUODENAL WALL. IN ADDITION, THE PATIENT HAS A HISTORY OF PRIMARY BILIARY CIRRHOSIS AND MAY HAVE BEEN ON CHRONIC STEROIDS, WHICH CAN INCREASE TISSUE FRIABILITY AND MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF PERFORATION. DUODENAL PERFORATIONS ARE A REPORTED COMPLICATION OF PLASTIC BILIARY STENTS, AND IN THE LITERATURE, INAPPROPRIATELY LONG AS WELL AS STRAIGHT (NON-PIGTAIL), BILIARY STENTS APPEAR TO BE ASSOCIATED WITH A HIGHER LIKELIHOOD OF DUODENAL PERFORATION DUE TO THE DIRECT PRESSURES EXERTED ON THE DUODENAL WALL. A SHORTER STENT, POSITIONED WITH THE CRANIAL ASPECT CLOSER TO THE FOCAL STENOSIS AND DISTAL ASPECT JUST DISTAL TO THE AMPULLA, WOULD HAVE LIKELY DECREASED THE RISK OF PERFORATION IN THIS INDIVIDUAL. THE OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE AS FOLLOWS: DEVELOPMENT OF DUODENAL PERFORATION FROM BILIARY STENT FELT TO BE RELATED TO STENT LENGTH AND POSITION OF DEPLOYMENT THE OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE WERE AS FOLLOWS: PATIENT HAS PRIMARY BILIARY CIRRHOSIS AND MAY HAVE BEEN ON AN IMMUNOMODULATOR, SUCH AS CORTICOSTEROIDS, LEADING TO MORE FRIABLE TISSUES AND THEREFORE POTENTIALLY CONTRIBUTING TO THE DEVELOPMENT OF DUODENAL PERFORATION. THE IMAGE REPORT WAS REVIEWED BY THE MEDICAL ADVISOR AT CIRL WHO CONCURS WITH THE IMAGE REVIEW REPORT FINDINGS OUTLINING THAT THE DEVELOPMENT OF DUODENAL PERFORATION FROM BILIARY STENT WAS RELATED TO STENT LENGTH CHOSEN FOR PLACEMENT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN A LABORATORY SETTING. A PROBABLE ROOT CAUSE FOR THIS COMPLAINT MAY BE ATTRIBUTED TO THE INAPPROPRIATE STENT LENGTH CHOSEN WHICH MAY HAVE CONTRIBUTED TO EARLY MIGRATION AND PERFORATION. FEEDBACK FROM R&D ENGINEERING VIEWED THAT THE CHOICE OF STENT (I.E. STENTS THAT ARE TOO LONG OR TOO SHORT) MAY BE A CONTRIBUTORY FACTOR TO THIS COMPLAINT. A STENT THAT IS TOO SHORT WILL NOT BRIDGE THE STRICTURE AND MIGRATE OUT OF THE DUCT OR A STENT THAT IS TOO LONG WILL SIT TOO FAR BEYOND THE STRICTURE SUCH THAT THE FLAP IS NOT ANCHORED AGAINST ANYTHING WHICH MAY CAUSE IT TO MIGRATE UNTIL IT ANCHORS AGAINST THE STRICTURE OR THE DUODENAL WALL (DEPENDING ON WHAT IT REACHES FIRST). FEEDBACK FROM CLINICAL PERSONNEL AT CIRL SUGGESTS THAT MIGRATION/PERFORATION MAY BE RELATED TO PAPILLOTOMY AND THE PHYSICIANS MAY HAVE LEFT THE DUODENAL END TOO LONG INTO THE DUODENUM. THE SUMMARY FROM THE MEETING BETWEEN COOK MEDICAL PERSONNEL AND PHYSICIANS AT THE MEDICAL FACILITY SUGGESTS THAT ON REVIEW OF THE IMAGES, THE STENTS HAVE A CERTAIN SHAPE SET AFTER PLACEMENT WHEREBY THERE IS PRESSURE IN THE SENT AT DIFFERENT LEVELS THAT COULD CONTRIBUTE TO EARLY MIGRATION. HOWEVER THIS MAY BE UNCERTAIN. THE COMPLAINT IS CONFIRMED BASED ON THE INDEPENDENT CLINICAL REVIEW OF THE IMAGES AND PERFORATION HAD OCCURRED FOLLOWING STENT MIGRATION. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0045-6, "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION". ACCORDING TO INSTRUCTION FOR USE, IFU0045-6, THE USER IS ADVISED OF THE FOLLOWING PRECAUTIONS: "THE TAPERED END OF THE STENT* OR SIDE HOLES* MUST BE POSITIONED IN THE COMMON BILE DUCT WHILE THE OTHER END REMAINS IN THE DUODENUM. THE LONGER LAPS OF THE ST-2 BILIARY STENT SHOULD BE POSITIONED IN THE DUCT WHILE THE SHORTER FLAPS REMAIN THE DUODENUM." SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE INDEPENDENT CLINICAL REVIEW OF THE IMAGES AND PERFORATION HAD OCCURRED FOLLOWING STENT MIGRATION. FOLLOWING THE MEETING BETWEEN MEETING BETWEEN COOK MEDICAL PERSONNEL AND PHYSICIANS AT THE MEDICAL FACILITY, IT WAS AGREED THAT THE FACILITY WOULD CHANGE TO TANNENBAUM STENTS WITH THE USE OF HUIBREGTSE DESIGN STENTS AS A BACK UP FOR THE LEFT SIDE STRICTURE. THE USE OF THESE STENTS WILL BE CLOSELY MONITORED. THE PRODUCT MANAGER HAS BEEN NOTIFIED OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INITIAL MDR IS BEING SUBMITTED BASED ON SURGICAL INTERVENTION. HILAR STENOSE RIGHT AND LEFT PERFORATION DETECTED 6 DAYS AFTER ERCP. PAPILLOTOMY: YES. DILATION LEFT: 4 MM. ACTION TAKEN: OTSC. LOT NUMBER NOT CONFIRMED.
THIS MDR IS BEING SUBMITTED BASED ON SURGICAL INTERVENTION. HILAR STENOSE RIGHT AND LEFT PERFORATION DETECTED 6 DAYS AFTER ERCP. PAPILLOTOMY : YES. DILATION LEFT: 4MM. ACTION TAKEN: OTSC. LOT NUMBER NOT CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140681 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |