COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2024-00140
- Event Type
- Injury
- Date Received
- April 5, 2024
- Date of Event
- January 16, 2019
- Report Date
- June 18, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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: (B)(4) UNIT OF CLSO-10-10 OF LOT NUMBER UNKNOWN WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS NO DEVICE WAS RETURNED. MANUFACTURING RECORDS: AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT WORK ORDER COULD NOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION, ALL CLSO-10-10 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. REVIEW HISTORICAL DATA: HISTORICAL DATA COULD NOT BE REVIEWED AS LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: THE INSTRUCTIONS FOR USE (IFU0045), WHICH ACCOMPANIES THIS DEVICE ADVISES THE USER ON POTENTIAL COMPLICATIONS: THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION. THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE BUT ARE NOT LIMITED TO: STENT MIGRATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION REPORTED. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO BOTH THE STENT AND PROCEDURE AS PER THE DEVICE IFU, MIGRATION AND PERFORATION ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH PLACEMENT OF THE DEVICE. POTENTIAL CAUSES WERE LISTED IN THE ARTICLE AND HIGHLIGHTED BY MEDICAL ADVISOR, 1. THE STENT MAY BE PLACED INCORRECTLY, LEADING TO IRRITATION AND, EVENTUALLY NECROSIS OF THE DUODENAL MUCOSA. 2. INFLEXIBILITY OR INCORRECT LENGTH OF THE STENT MAY IRRITATE THE DUODENAL MUCOSA AND LEAD TO PRESSURE NECROSIS. 3. ADHESION OF HE TUMOR TO THE PROXIMAL PORTION OF THE PS MAY INCREASE TRAUMA CAUSED BY THE DISTAL INTRADUODENAL SEGMENT OF THE PS, PREVENTING ITS ADAPTION TO INTESTINAL PERISTALSIS. FROM THE AVAILABLE INFORMATION, THE PATIENT HAD UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY WHICH RESULTED IN A BILIARY LEAK. IT IS KNOWN AS PER THE DEVICE IFU THAT BOTH PERFORATION AND MIGRATION ARE KNOWN POTENTIAL COMPLICATIONS OF USING THE DEVICE. INPUT FROM THE MEDICAL ADVISOR ALSO CONFIRMS MIGRATION AND DUODENAL PERFORATION ARE RARE. ALL PATIENTS IN THIS STUDY WERE RECOVERED WITHOUT SEVERE COMPLICATIONS OR DEATH. COMPLAINT IS CONFIRMED BASED CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: FAILURE IDENTIFIED - STENT PERFORATION - 01 DEVICE CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT EXPERIENCED DUODENAL PERFORATION WHICH REQUIRED INTERVENTION/ADDITIONAL PROCEDURES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION REPORTED. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO BOTH THE STENT AND PROCEDURE AS PER THE DEVICE IFU, MIGRATION AND PERFORATION ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH PLACEMENT OF THE DEVICE. POTENTIAL CAUSES WERE LISTED IN THE ARTICLE AND HIGHLIGHTED BY MEDICAL ADVISOR, 1. THE STENT MAY BE PLACED INCORRECTLY, LEADING TO IRRITATION AND, EVENTUALLY NECROSIS OF THE DUODENAL MUCOSA. 2. INFLEXIBILITY OR INCORRECT LENGTH OF THE STENT MAY IRRITATE THE DUODENAL MUCOSA AND LEAD TO PRESSURE NECROSIS. 3. ADHESION OF HE TUMOR TO THE PROXIMAL PORTION OF THE PS MAY INCREASE TRAUMA CAUSED BY THE DISTAL INTRADUODENAL SEGMENT OF THE PS, PREVENTING ITS ADAPTION TO INTESTINAL PERISTALSIS. FROM THE AVAILABLE INFORMATION, THE PATIENT HAD UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY WHICH RESULTED IN A BILIARY LEAK. IT IS KNOWN AS PER THE DEVICE IFU THAT BOTH PERFORATION AND MIGRATION ARE KNOWN POTENTIAL COMPLICATIONS OF USING THE DEVICE. INPUT FROM THE MEDICAL ADVISOR ALSO CONFIRMS MIGRATION AND DUODENAL PERFORATION ARE RARE. ALL PATIENTS IN THIS STUDY WERE RECOVERED WITHOUT SEVERE COMPLICATIONS OR DEATH. COMPLAINT IS CONFIRMED BASED CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
SHIN HEE KIM ET AL., 2019 ¿ ENDOSCOPIC MANAGEMENT OF DUODENAL PERFORATIONS CAUSED BY MIGRATED BILIARY PLASTIC STENTS. SHIN HEE KIM ET AL., 2019 ¿ ENDOSCOPIC MANAGEMENT OF DUODENAL PERFORATIONS CAUSED BY MIGRATED BILIARY PLASTIC STENTS. A 50-YEAR-OLD MALE WITH END-STAGE RENAL DISEASE PRESENTED WITH DIFFUSE ABDOMINAL PAIN. HE HAD UNDERGONE EBD USING A PS (CLSO, 10 FR, 10 CM; COOK ENDOSCOPY, WINSTON-SALEM, NORTH CAROLINA, UNITED STATES) 4 WEEKS PRIOR FOR TREATMENT OF A BILIARY LEAK AFTER LAPAROSCOPIC CHOLECYSTECTOMY. THE PATIENT HAD A DISTENDED ABDOMEN AND DIFFUSE ABDOMINAL TENDERNESS, AND AN ABDOMINAL X-RAY SHOWED DISTAL MIGRATION OF THE PANCREATIC STENT. ABDOMINAL COMPUTED TOMOGRAPHY (CT) DEMONSTRATED THAT THE PANCREATIC STENT HAD PENETRATED THE PERITONEAL CAVITY THROUGH THE DUODENAL WALL. ENDOSCOPIC FINDINGS SHOWED A DUODENAL FISTULA, AND THE PROXIMAL PORTION OF THE PANCREATIC STENT WAS ALMOST PENETRATING THE DUODENAL WALL. THIS COMPLAINT IS BEING OPENED TO CAPTURE 1 PATIENT EXPERIENCE OF PERFORATION. PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=+4.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 18-JUN-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2334317 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |