COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2018-00240
- Event Type
- Injury
- Date Received
- May 22, 2018
- Date of Event
- March 22, 2018
- Report Date
- April 24, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
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 IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
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: ED SUTKOWSKI (B)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 ADDITIONAL INFORMATION: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES IF YES, PLEASE DESCRIBE. REMOVAL OF STENT AND PLACEMENT OF HEMOCLIP TO CLOSE DEFECT. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. STENT MIGRATED AND PERFORATED DUODENUM HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? YES HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. SEVERE ABDOMINAL PAIN (CAUSED BY STENT MIGRATION/PERFORATION OF DUODENUM) ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN ON 02MAY2018: "THE STENT WAS INSERTED ON 1/21/2018. THE STENT WAS REMOVED ON 3/22/2018. 65 YEAR OLD FEMALE WITH NORMAL ANATOMY. HAD STENTING DONE FOR HILAR CHOLANGIOCARCINOMA. SHE WAS ON CHEMOTHERAPY AT THE TIME THE PERFORATION OCCURRED." THERE WERE THREE ATTEMPTS MADE TO OBTAIN THE FOLLOWING ADDITIONAL INFORMATION AND A RESPONSE HAS NOT BEEN RECEIVED TO DATE. IF THERE WAS ANOTHER STENT PLACED INSTEAD OF THE CLSO-10-12 WHEN IT WAS REMOVED? THE PATIENT WAS ON CHEMO ¿ WAS THE CHEMO EFFECTIVE IN REDUCING THE TUMOUR SIZE THAT WAS AFFECTING THE FLUID FLOW IN BILE DUCT WAS A SPHINCTEROTOMY PERFORMED? HOW MANY STENTS WERE INITIALLY PLACED ¿ IE. WAS IT JUST ONE CLSO-10-12 OR WERE THERE SEVERAL? WHAT WAS THE PATIENT'S DIAGNOSIS? WHAT WAS THE TYPE OF CANCER AND WHAT STAGE? ARE X-RAYS AVAILABLE FOR EVALUATION? LAB EVALUATION: 1 X CLSO-10-12 OF AN UNKNOWN LOT NUMBER WAS INVOLVED IN THIS COMPLAINT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DOCUMENT-BASED INVESTIGATION WAS COMPLETED. CLINICAL REVIEW: THE MEDICAL ADVISOR AT COOK IRELAND REVIEWED THE COMPLAINT. THE FOLLOWING COMMENTS WERE MADE ABOUT FACTORS THAT MAY CONTRIBUTE TO STENT MIGRATION AND PERFORATION OUTLINED IN THIS COMPLAINT: (REFERENCE: RE PR225521 STENT MIGRATION COMPLAINT - CLINICAL OPINION 15TH MAY 2018.MSG) (1) COMMON BILE DUCT DIAMETERS (2) DISTAL BILIARY STRICTURES (3) STRAIGHT PLASTIC STENT (CLSO) VS PIGTAIL STENT (4) CHEMOTHERAPY (5) DUODENAL INVASION BY TUMOR (6) STENT LENGTH/LOCATION/POSITION ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED, AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN A LABORATORY SETTING AND LIMITED INFORMATION WAS RECEIVED FROM THE COMPLAINT ORIGINATOR. A POSSIBLE 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 ENGINEERING R&D OUTLINED SOME FACTORS THAT MAY CONTRIBUTE TO THE STENT MIGRATION AND PERFORATION OUTLINED IN THIS COMPLAINT: (1) THE STENT CHOSEN WAS TOO LONG AND IT MIGRATED DUE TO NON ENGAGEMENT OF THE ANTI-MIGRATION FEATURE WITH THE STRICTURE. (2) THE TUMOUR SHRUNK AND THERE WAS NOTHING FOR THE ANTI-MIGRATION FEATURE TO ANCHOR AGAINST CAUSING THE STENT TO MIGRATE. (3) THE STENT WAS TOO SHORT INITIALLY AND THE FLAP WAS NOT ABOVE THE STRICTURE TO ANCHOR IT. (4) THE STENT WAS PLACED WHERE THERE WAS NO STRICTURE. (5) THE STENT WAS INITIALLY PLACED WITH TOO MUCH OF IT EXTENDING INTO THE DUODENUM. (6) THE STENT HAD A MANUFACTURING ERROR AND NO FLAPS WERE PRESENT ON IT. (HIGHLY UNLIKELY ¿ CHECKED AT FINAL QUALITY CONTROL) (7) THE STENT HAD A MANUFACTURING ERROR AND THE FLAPS WERE TOO SHORT. (HIGHLY UNLIKELY ¿ CHECKED AT FINAL QUALITY CONTROL) THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. FQC/PKG REVIEW: PRIOR TO DISTRIBUTION, ALL CLSO DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. 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: PERFORATION. 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". SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INITIAL MDR IS BEING SUBMITTED BASED SERIOUS INJURY, THE PHYSICIAN REPORTED STENT MIGRATION AND PERFORATION OF THE DUODENUM. AS REPORTED TO CUSTOMER RELATIONS: "I WAS IN A CASE WITH DR. (B)(6) YESTERDAY AND HE MENTIONED THAT HE HAD PLACED A CLSO-10-12 STENT IN (B)(6)¿TWO WEEKS LATER, PATIENT RETURNED WITH SEVERE ABDOMINAL PAIN. WAS SCOPED BY DR. (B)(6); DR. (B)(6) DISCOVERED THAT THE STENT MIGRATED AND PERFORATED THE DUODENUM. SHE WAS ABLE TO REMOVE THE STENT AND WAS ABLE TO CLOSE THE DEFECT USING A BEAR CLAW HEMOCLIP (NOT A COOK PRODUCT). PATIENT RECOVERED FULLY, NO ADDITIONAL INTERVENTION REQUIRED. DEVICE NOT AVAILABLE FOR RETURN. LOT NUMBER IS UNKNOWN (DEVICE THROWN OUT)." ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN ON 02MAY2018: "THE STENT WAS INSERTED ON (B)(6) 2018. THE STENT WAS REMOVED ON (B)(6) 2018. 65 YEAR OLD FEMALE WITH NORMAL ANATOMY. HAD STENTING DONE FOR HILAR CHOLANGIOCARCINOMA. SHE WAS ON CHEMOTHERAPY AT THE TIME THE PERFORATION OCCURRED."
INITIAL MDR IS BEING SUBMITTED BASED SERIOUS INJURY, THE PHYSICIAN REPORTED STENT MIGRATION AND PERFORATION OF THE DUODENUM. AS REPORTED TO CUSTOMER RELATIONS: "I WAS IN A CASE WITH DR. KAVEH SHARZEHI ([email protected]) YESTERDAY AND HE MENTIONED THAT HE HAD PLACED A CLSO-10-12 STENT IN FEBRUARY¿TWO WEEKS LATER, PATIENT RETURNED WITH SEVERE ABDOMINAL PAIN. WAS SCOPED BY DR. ENESTVEDT; DR. ENESTVEDT DISCOVERED THAT THE STENT MIGRATED AND PERFORATED THE DUODENUM. SHE WAS ABLE TO REMOVE THE STENT AND WAS ABLE TO CLOSE THE DEFECT USING A BEAR CLAW HEMOCLIP (NOT A COOK PRODUCT). PATIENT RECOVERED FULLY, NO ADDITIONAL INTERVENTION REQUIRED. DEVICE NOT AVAILABLE FOR RETURN. LOT NUMBER IS UNKNOWN (DEVICE THROWN OUT)." ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN ON 02MAY2018: "THE STENT WAS INSERTED ON 1/21/2018. THE STENT WAS REMOVED ON 3/22/2018. 65 YEAR OLD FEMALE WITH NORMAL ANATOMY. HAD STENTING DONE FOR HILAR CHOLANGIOCARCINOMA. SHE WAS ON CHEMOTHERAPY AT THE TIME THE PERFORATION OCCURRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377634 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |