GEENEN PANCREATIC STENT SET
Report
- Report Number
- 3001845648-2019-00695
- Event Type
- Injury
- Date Received
- December 9, 2019
- Report Date
- June 22, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE INITIAL BLEEDING ALONG WITH THE USER ERROR IS CAPTURED UNDER REPORT REF#: 3001845648-2019-00694. THIS REPORT WAS A DUPLICATION.
LITERATURE REPORTED EVENT. ¿MASSIVE HEMOBILIA FOLLOWING PLASTIC STENT REMOVAL IN COMMON BILE DUCT CANCER ASSOCIATED WITH PRIMARY SCLEROSING CHOLANGITIS.¿ A 72-YEAR-OLD MAN, WHO WAS DIAGNOSED AS HAVING PSC 1 YEAR PREVIOUSLY, HAD UNDERGONE REPEATED INSERTION OF A PS INTO THE CBD FOR THE TREATMENT OF OBSTRUCTIVE JAUNDICE. WHILE TWO BILIARY PSS (GEPD-5-12, COOK IRELAND, LTD., LIMERICK, IRELAND) WERE BEING EXCHANGED, BILIARY TRACT BIOPSY USING BIOPSY FORCEPS (E634043, OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) WAS PERFORMED BASED ON THE SUSPICION OF CBD CANCER DUE TO THE PROGRESSION OF CBD STENOSIS. WHEN ONE OF THE TWO BILIARY PSS WAS REMOVED USING A SNARE, PULSATILE BLEEDING FROM THE MAJOR PAPILLA BEGAN ABRUPTLY. AS A RESULT OF THE MASSIVE BLEEDING, THE PATIENT WENT INTO A PRE-SHOCK STATE OWING TO DECREASED BLOOD PRESSURE AND TACHYCARDIA. DURING THE BLEEDING, CANNULATION OF THE MAJOR PAPILLA WAS PERFORMED AND A GUIDEWIRE WAS INSERTED INTO THE BILIARY TRACT. A RETRIEVAL BALLOON CATHETER (B-V232P-B, OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) WAS COMPRESSED AGAINST THE MAJOR PAPILLA FOR HEMOSTASIS (FIG. 2C). AFTER CESSATION OF BLEEDING FROM THE MAJOR PAPILLA, ONE PS (FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM, 7FRX7CM, BOSTON SCIENTIFIC CORP., MARLBOROUGH, MA, USA) WAS REINSERTED INTO THE BILIARY TRACT. DESPITE CONSERVATIVE TREATMENT, THE PATIENT DEVELOPED BLOODY DISCHARGE ON DAY 11 AFTER ERCP. UPPER GASTROINTESTINAL ENDOSCOPY SHOWED THAT THE PSS WERE COVERED BY FRESH COAGULATED BLOOD, AND THE PULSATILE BLEEDING BESIDE THE PSS STARTED IMMEDIATELY AFTER THE REMOVAL OF THE COAGULA. IT WAS JUDGED THAT ENDOSCOPIC HEMOSTASIS WOULD BE DIFFICULT. EMERGENT CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED A RIGHT HEPATIC ARTERY ANEURYSM ACROSS THE CBD. THEREFORE, TRANSARTERIAL EMBOLIZATION (TAE) WITH COILS WAS PERFORMED ON DAY 13 POST-ERCP. A SELF-EXPANDABLE METAL STENT (SEMS) (BONASTENT® FULL COVER STENT, 8 MM × 7 CM, SEWOON MEDICAL CO., LTD., CHEONANSI, CHUNGCHEONGNAM-DO, KOREA) WAS THEN INSERTED INTO THE CBD ON DAY 15 POST-ERCP (FIG. 4A, B). THE PATIENT¿S POSTTHERAPEUTIC COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED ON DAY 44 POST-ERCP. WE OBSERVED A LIFE-THREATENING CASE OF HEMOBILIA THAT OCCURRED WITH REMOVAL OF PS IN A PATIENT WITH CBD CANCER ASSOCIATED WITH PSC.
THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE INITIAL BLEEDING ALONG WITH THE USER ERROR IS CAPTURED UNDER REPORT REF#: 3001845648-2019-00694. THIS REPORT WAS A DUPLICATION.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
LITERATURE REPORTED EVENT; ARTICLE IS ATTACHED. ¿MASSIVE HEMOBILIA FOLLOWING PLASTIC STENT REMOVAL IN COMMON BILE DUCT CANCER ASSOCIATED WITH PRIMARY SCLEROSING CHOLANGITIS.¿ A (B)(6) MAN, WHO WAS DIAGNOSED AS HAVING PSC 1 YEAR PREVIOUSLY, HAD UNDERGONE REPEATED INSERTION OF A PS INTO THE CBD FOR THE TREATMENT OF OBSTRUCTIVE JAUNDICE. WHILE TWO BILIARY PSS (GEPD-5-12, COOK IRELAND, LTD., (B)(4)) WERE BEING EXCHANGED, BILIARY TRACT BIOPSY USING BIOPSY FORCEPS (E634043, OLYMPUS MEDICAL SYSTEMS, (B)(4)) WAS PERFORMED BASED ON THE SUSPICION OF CBD CANCER DUE TO THE PROGRESSION OF CBD STENOSIS. WHEN ONE OF THE TWO BILIARY PSS WAS REMOVED USING A SNARE, PULSATILE BLEEDING FROM THE MAJOR PAPILLA BEGAN ABRUPTLY. AS A RESULT OF THE MASSIVE BLEEDING, THE PATIENT WENT INTO A PRE-SHOCK STATE OWING TO DECREASED BLOOD PRESSURE AND TACHYCARDIA. DURING THE BLEEDING, CANNULATION OF THE MAJOR PAPILLA WAS PERFORMED AND A GUIDEWIRE WAS INSERTED INTO THE BILIARY TRACT. A RETRIEVAL BALLOON CATHETER (B-V232P-B, OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) WAS COMPRESSED AGAINST THE MAJOR PAPILLA FOR HEMOSTASIS (FIG. 2C). AFTER CESSATION OF BLEEDING FROM THE MAJOR PAPILLA, ONE PS (FLEXIMA BILIARY STENT WITH DELIVERY SYSTEM, 7FRX7CM, BOSTON SCIENTIFIC CORP., (B)(4)) WAS REINSERTED INTO THE BILIARY TRACT. DESPITE CONSERVATIVE TREATMENT, THE PATIENT DEVELOPED BLOODY DISCHARGE ON DAY 11 AFTER ERCP. UPPER GASTROINTESTINAL ENDOSCOPY SHOWED THAT THE PSS WERE COVERED BY FRESH COAGULATED BLOOD, AND THE PULSATILE BLEEDING BESIDE THE PSS STARTED IMMEDIATELY AFTER THE REMOVAL OF THE COAGULA. IT WAS JUDGED THAT ENDOSCOPIC HEMOSTASIS WOULD BE DIFFICULT. EMERGENT CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED A RIGHT HEPATIC ARTERY ANEURYSM ACROSS THE CBD. THEREFORE, TRANSARTERIAL EMBOLIZATION (TAE) WITH COILS WAS PERFORMED ON DAY 13 POST-ERCP. A SELF-EXPANDABLE METAL STENT (SEMS) (BONASTENT® FULL COVER STENT, 8 MM × 7 CM, SEWOON MEDICAL CO., LTD., CHEONANSI, CHUNGCHEONGNAM-DO, KOREA) WAS THEN INSERTED INTO THE CBD ON DAY 15 POST-ERCP (FIG. 4A, B). THE PATIENT¿S POSTTHERAPEUTIC COURSE WAS UNEVENTFUL, AND HE WAS DISCHARGED ON DAY 44 POST-ERCP. WE OBSERVED A LIFE-THREATENING CASE OF HEMOBILIA THAT OCCURRED WITH REMOVAL OF PS IN A PATIENT WITH CBD CANCER ASSOCIATED WITH PSC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1234126 | GEENEN PANCREATIC STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L| R |